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INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research - PowerPoint PPT Presentation

INTRODUCTION TO CLINICAL RESEARCH Lecture 1: Who, What, Why and Where of Clinical Research

Introduction to clinical research lecture 1: who, what, why and where of clinical research richard j. barohn, m.d. professor and chairman department of neurology – powerpoint ppt presentation.

• Richard J. Barohn, M.D.
• Professor and Chairman
• Department of Neurology
• Director, General Clinical Research Center
• University of Kansas Medical School
• August 24, 2006
• Types of clinical research
• Retrospective looking back at data previously collected
• - Case Reports
• - Case Series
• Prospective make plan for future data collection
• - Observational
• - Interventional
• - Device/technique
• Can involve direct participant contact
• - Measure a clinical end-point
• Obtain tissue samples from participant to study in the laboratory
• Can be data-mining of clinical databases
• - Never see participant
• - Example Medicare database
• Survival (mortality)
• Physiologic parameter
• Example quantitative strength, breathing (vital capacity)
• Clinical scales
• Example Mini Mental Status
• Blood or other body tissue measurement
• Example - Glucose Level
• - Hormone Level
• Open-label Trial
• Everyone receives research intervention
• Controlled Trial
• Some receive research intervention, some do not
• Control group - Ones that do not receive research intervention
• Control group can be getting another intervention
• Comparing new drug to older one
• Or control group can get placebo (inactive intervention)
• Randomized Trials
• Participants randomly allocated to active intervention or control group
• Blinded usually double blind
• Doctor and participant do not know which group subject is in
• Gold Standard Randomized Double-Blinded Controlled Trial
• Most proceeded by beneficial results in laboratory models
• All multicenter with other ALS centers
• COX-2 inhibitor (glutamate inhibitor) (MDA)
• Celebrex trial just completed no benefit
• ? improves strength in athletes (NIH)
• Minocycline oral (cell death inhibitor) (NIH)
• Ceftriaxone intravenous (cell death inhibitor) (NIH)
• CoQ10 (antioxidant) (NIH)
• Arimoclomol (increases heat shock protein) (Biotech investigator initiated)
• Celebrex/creatine vs mino/creatine (ALSA)
• Pre-Clinical Animal and In Vitro Lab Studies
• Phase I Safety (normals disease)
• Phase II Preliminary Efficacy Data with
• additional safety
• usually lt 100 patients
• Phase III Pivotal efficacy trial
• Large, often multicenter
• Phase IV - Post-marketing
• In Academic Health Centers
• Faculty MD, DO, PhD are Principal Investigators and Co-Investigators in Schools of Medicine, Nursing, Allied Health
• Trainees (students, residents, fellows) work under Faculty
• Outside of Academic Health Centers
• Private practice health care providers
• Pharmaceutical companies, example Quintiles
• Biomedical device companies
• Investigator
• Clinical Research Coordinators
• (Example nurse, respiratory therapist, RD)
• Clinical Research Evaluator
• Research Assistant
• Biostatistician
• Data Manager
• Research Pharmacy
• If laboratory based
• Lab research personnel (students, post doctorate, technicians)
• Federal Grants
• Example National Institutes of Health
• FDA-Orphan Drug Grant Program
• Foundations
• Example Muscular Dystrophy Association
• Internal-funding at medical center
• Example Research Institute of KUMC
• Private Donations
• Non-Funded Research
• Local Institutional Support
• KUMC Research Institute
• Disease-Related Foundations
• Standard Research Grants
• Career Development Grants
• NIH (NIH.gov)
• Apply to NIH for
• K23 Clinical Research
• K08 Lab/Translational
• R03 Pilot Program
• R21 Developmental/Exploratory
• Institutional Awarded Training Grants
• T32 Training
• K12 Career Development
• VA Career Development Awards
• Merit Grants
• GOAL RO-1 THE BIG ONE
• Food Drug Administration (FDA)
• PI applies to get IND for drug trial
• Local Human Subjects Committee (Institutional Review Board)
• Local HIPPA Compliance Program
• General Clinical Research Center
• Research Subject Advocate
• Safety Monitors
• Data Safety Monitoring Boards
• Local KUMC DSMB
• National NIH DSMB
• Research Institute Clinical Trials Office
• Serve as centralized sponsor contact point for KUMC
• Prepares consent with PI input
• Prepares and negotiates trial budgets
• Submits protocol/consent to HSC if there is a sponsor
• Contact Laurie Kemble at 588-1242 or http//www2.kumc.edu/researchinstitute/
• Human Subjects Committee
• KUMCs Institutional Review Board
• Committed to ethical, legal and safe conduct in all research involving human participants
• Meets 2nd and 4th Tuesdays
• Submissions by noon Friday, 7 business days prior to meeting
• Submission of materials
• Contact Karen Blackwell at 588-0942 or http//www.kumc.edu/hipaa/
• Focus on steering mechanism not the
• drive train or brakes, as they are
• not usually accessible to mentors.
• The mentor should
• Be interested
• Have experience
• Be available
• Limit number of mentees
• Commit substantial time
• Be vigilant but not intrusive
• In academic health centers
• Departmental clinical space
• Designated research space
• Example GCRC
• Hoglund Brian Imaging Center
• Veterans Administration Medical Centers
• Hospitals not affiliated with AHC
• NIH in Bethesda intramural
• Private health care provider offices
• Industry offices
• Advance science/improve knowledge
• Obtain access to a potential Rx at the earliest possible time
• Current Rx not working
• It helps maintain hope - better than not doing anything
• Desire to meet and speak with researchers
• To help others
• Reimbursement to subject/patient
• Painful unpleasant procedures
• Fear of going off current medication
• New treatment may not be better
• Time commitment/travel
• Side effects
• Fear of the unknown
• Fear of being assigned to placebo
• They accept the disease is their fate
• Efforts futile
• Privacy concerns publication, etc.
• Resentment of medical personnel
• Distrust of science community
• Dont want to be a guinea pig
• Dont agree with focus of research
• Long wait to get research results
• Be considered a partner in the research
• Be treated with respect / taken seriously, kept informed and up-to-date
• Do not want to be talked down to
• Full disclosure of side effects
• Option to stop involvement in study
• Support from research team - availability
• After study, want to know results and if they were on drug or placebo
• Realistic idea when results will be available
• No cost to participant
• Confidentiality
• Enough time and comfortable area
• To ask questions
• In which to do the study
• A NIH-supported multidisciplinary research unit which facilitates investigator-initiated clinical studies and trials conducted by full-time faculty of the AHC.
• Provides clinical research infrastructure to investigators who receive funding from federal agencies, private foundations, other peer-reviewed sources.
• Also, can include investigator initiated unfunded pilot studies and industry sponsored studies.
• This is at no cost to the PIs for Investigator-Initiated Trials
• Provide clinical investigators from the SOM, SON, and SOAH with a modern, state-of-the-art facility in which clinical research could be conducted
• Enhance multidisciplinary research across departments and the three schools
• Enable and train junior faculty and trainees to become more involved in clinical research
• Apply for federal funding to support the GCRC
• Outpatient Unit
• Inpatient Unit
• Scatter Beds
• Metabolic Kitchen
• Informatics Core
• VOTING MEMBERS
• Matthew Mayo, PhD
• Jared Grantham, MD
• Marge Bott, RN, PhD
• Richard McCallum, MD
• Stephen Williamson, MD
• Richard Dubinsky, MD
• Barbara Lukert, MD
• Kevin Latinis, MD, PhD
• Debra Sullivan, PhD, RD, LD
• Patrick Moriarty, MD
• Jo Ann Harris, MD
• John Ferraro, PhD
• Andrea Charbonneau, MD
• Kathryn Ellerbeck, MD
• Ossama Tawfik, PhD, MD
• Barbara Quaney, PT, PhD
• Kathleen Gustafson, PhD
• NON-VOTING EX OFFICIO MEMBERS
• Barbara Atkinson, MD Executive Dean SOM
• Richard J. Barohn, MD Program Director
• Curt Hagedorn, MD Associate Director
• Jeff Burns, MD Assistant Director
• Patricia Kluding, PT, PhD Assistant Director
• Paul Terranova, PhD
• Susan Schmitz, BA, CCRC Administrative Director
• Judy Otey, RN, BSN Nurse Manager
• Ed Ellerbeck, MD, MPH
• Jon Jackson
• Jo Denton, MSN
• Laurie Kemble, BS, CRT
• For GAC approved studies
• Space to see patients
• Biostat support study design
• Data management
• Nurse support
• Administrative support
• Specimen collection/storage
• Common equipment
• No cost for above services to PIs on investigator initiated studies
• Industry sponsored with charges for space/resources
• Space/resources for industry studies
• Permanent space for research coordinators
• Overnight stay on GCRC unit
• GCRC Planning Committee formed 2002
• Construction/Remodeling began June 1, 2004
• Completed October 2004
• 6, 000 square feet in Delp
• Announce GAC will accept research applications from investigators, September 2004
• Began doing studies on GCRC January 2005
• Approval of 53 on-going studies by GAC as of June 2006
• GCRC NIH grant submitted June 1, 2006
• 2 million (direct costs) per year for 3 years
• Contact Judy Otey, RN, BSN
• GCRC Administrative Director
• 913-588-0984 alt. 2460
• jotey_at_kumc.edu
• Nicole Ladesich, BS
• GCRC Senior Coordinator
• 913-588-0976 alt. 2294
• nladesich_at_kumc.edu
• Visit Website http//gcrc.kumc.edu
• Recruiting and retaining researchers
• Explosion in clinical demands, reduced financial margins ? limit time, diluted value
• Regulatory burden
• Fragmented training
• Complexity of training
• No real HOME for clinical researchers
• Limitations / barriers due to NIH funding mechanisms, review, program structures
• Clinical Research covers all studies of diseases and trials of
• treatments in human subjects
• Translational Research describes the steps between a
• fundamental discovery and its application in clinical
• medicine. For example
• Testing a new anti-cancer drug in humans for the first time
• Identifying best practices in the diagnosis, prevention, or management of a disease and enhancing their adoption by the community
• Purpose Forge a transformative and integrative academic home for clinical and translational science
• The home must be a Center, Department, or Institute.
• Encompass all components of clinical research (education, career development, clinical research infrastructure)
• Promote multidisciplinary research teams
• Create an incubator for innovative research tools
• Catalyze the application of new knowledge to clinical practice
• Degree granting capabilities in Clinical Research
• Masters and/or PhD
• No current GCRC funding
• Current K12 applicability?
• Small pool of clinical mentors, current clinical R01s
• Limited culture for CR
• GCRC infrastructure
• Institutional support
• Research Institute
• SOM / SON / SOAH
• Bioinformatics Center (Mayo)
• K-BRIN (Hunt)
• KU Lawrence (Georg and others)
• Intro to CR Course
• K30 (MSCR program)
• KU Lawrence
• Life Span Institute
• Drug Development
• Introduction to CR Course
• No Clinical T32
• Letter of Intent February 27, 2006
• Grant Application March 27, 2006
• Planning grant 150,000 for 1 year
• Full CTSA up to 6 million with pediatrics
• 4 million without pediatrics
• Existing K30, T32, and GCRC are in addition
• 5 year award RFA offered annually
• Goal 60 CTSAs to be awarded by 2012
• Will replace all GCRCs and NCRR / Roadmap K12s
• Planning Steering Committee
• Barbara Atkinson, MD
• Richard J. Barohn, MD
• Governance Planning Sub-Committee
• Grant Writing Planning Sub-Committee
• Lauren Aaronson, PhD, RN
• Education Planning Committee
• Chair Ed Ellerbeck, MD, MPH
• Clinical Research Resources Planning Committee
• Regulatory Planning Committee
• Jim Voogt, PhD
• John Finley, JD, MPH
• Novel Methods Translational Technologies Planning Committee
• Curt Hagedorn, MD
• Health Disparities Research Planning Committee
• Patricia Thomas, MD
• Kirby Randolph, PhD
• Community Participant Planning Committee
• Joshua Freeman, MD

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Top 10 Clinical Research Roadmap PowerPoint Presentation Templates in 2024

Introducing our Clinical Research Roadmap PowerPoint presentation, a fully editable and customizable tool designed to streamline the complex journey of clinical research. This comprehensive roadmap visually guides researchers, sponsors, and stakeholders through the essential phases of clinical trials, from initial concept development to regulatory submission and post-marketing surveillance. With an intuitive layout and clear milestones, our presentation helps teams align their objectives, timelines, and resources effectively, ensuring that every critical step is accounted for.Use cases for the Clinical Research Roadmap are vast and varied. It serves as an invaluable resource for academic institutions, pharmaceutical companies, and contract research organizations (CROs) looking to enhance their project management capabilities. Researchers can utilize the roadmap to present their study plans to stakeholders, ensuring transparency and fostering collaboration. Additionally, it can be employed in training sessions for new team members, providing them with a clear understanding of the clinical trial process. By customizing the roadmap to fit specific projects, organizations can effectively communicate their strategies, track progress, and adapt to challenges, ultimately driving successful outcomes in clinical research. Elevate your presentations and facilitate better decision-making with our Clinical Research Roadmap today!

Quarterly clinical research roadmap for human medicine

Presenting Quarterly Clinical Research Roadmap For Human Medicine PowerPoint Template. This PPT presentation is Google Slides compatible hence it is easily accessible. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements.

Utilize our pre build Quarterly Clinical Research Roadmap For Human Medicine to present your plan of action in the most effective way. Reduce the paperwork and showcase how different activities are linked to each other by incorporating this attention grabbing PowerPoint theme. This completely editable roadmap PPT layout is suitable to fit all your needs and to have a structured outline of the entire process flow using color coding. Provide guidelines to your teammates about the progression process by employing our PPT theme. Team members can easily be designated into teams by accessing the work milestones to be accomplished within the timeframe. You can easily modify the PowerPoint slide according to real time situations. Download our stunning Quarterly Clinical Research Roadmap For Human Medicine, and you are good to go to prove your expertise in strategic planning.

Quarterly clinical research roadmap with different phases

Presenting Quarterly Clinical Research Roadmap With Different Phases PowerPoint slide which is percent editable. You can change the color, font size, font type, and shapes of this PPT layout according to your needs. This PPT template is compatible with Google Slides and is available in both 4,3 and 16,9 aspect ratios. This ready to use PowerPoint presentation can be downloaded in various formats like PDF, JPG, and PNG.

A cohesive work plan is essential for achieving the desired target. Communicate your vision and lay a firm ground in front of your audience with our PowerPoint layout. Align your project milestones, budgets, deliverables, deadlines, and all the requisite information for a dynamic presentation by employing this amazingly designed Quarterly Clinical Research Roadmap With Different Phases. Maximize team efficiency and streamline a work plan efficiently by introducing our ready made roadmap PowerPoint theme. You can quickly establish coordination between different activities across the organization and present an insight to your colleagues by utilizing this useful business tool. Color code specific tasks, prioritize, and keep a close eye on the deadlines with the help of our eye catchy PowerPoint template. Download our Quarterly Clinical Research Roadmap With Different Phases for excelling at productive management.

Quarterly clinical research roadmap with drug review

Presenting Quarterly Clinical Research Roadmap With Drug Review PowerPoint slide. This PPT presentation is Google Slides compatible hence it is easily accessible. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG.

A well thought out action plan makes execution easier and increases the possibility of success significantly. Ensure hitting all the milestones within the deadlines by introducing our fully customizable Quarterly Clinical Research Roadmap With Drug Review. Streamline the work related information, budget, timeframe, key deliverable, landmarks, and major steps involved, all in one place to give an organized overview of the project by utilizing our PowerPoint theme. Minimize time lag and increase work efficiency by providing insight into the process with our comprehensively researched roadmap PowerPoint layout. Color coding helps in highlighting the process and grabs the attention of the audience. Download our handy Quarterly Clinical Research Roadmap With Drug Review to identify the possible problem areas in a much shorter time and propose solutions. Have a productive brainstorming session with your workforce by utilizing our action plan visualization tool.

Five years clinical research roadmap for human medicine

Presenting Five Years Clinical Research Roadmap For Human Medicine PowerPoint Template. This PPT presentation is Google Slides compatible hence it is easily accessible. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements.

Utilize our pre build Five Years Clinical Research Roadmap For Human Medicine to present your plan of action in the most effective way. Reduce the paperwork and showcase how different activities are linked to each other by incorporating this attention grabbing PowerPoint theme. This completely editable roadmap PPT layout is suitable to fit all your needs and to have a structured outline of the entire process flow using color coding. Provide guidelines to your teammates about the progression process by employing our PPT theme. Team members can easily be designated into teams by accessing the work milestones to be accomplished within the timeframe. You can easily modify the PowerPoint slide according to real time situations. Download our stunning Five Years Clinical Research Roadmap For Human Medicine, and you are good to go to prove your expertise in strategic planning.

Five years clinical research roadmap with different phases

Presenting Five Years Clinical Research Roadmap With Different Phases PowerPoint slide which is percent editable. You can change the color, font size, font type, and shapes of this PPT layout according to your needs. This PPT template is compatible with Google Slides and is available in both 4,3 and 16,9 aspect ratios. This ready to use PowerPoint presentation can be downloaded in various formats like PDF, JPG, and PNG.

A cohesive work plan is essential for achieving the desired target. Communicate your vision and lay a firm ground in front of your audience with our PowerPoint layout. Align your project milestones, budgets, deliverables, deadlines, and all the requisite information for a dynamic presentation by employing this amazingly designed Five Years Clinical Research Roadmap With Different Phases. Maximize team efficiency and streamline a work plan efficiently by introducing our ready made roadmap PowerPoint theme. You can quickly establish coordination between different activities across the organization and present an insight to your colleagues by utilizing this useful business tool. Color code specific tasks, prioritize, and keep a close eye on the deadlines with the help of our eye catchy PowerPoint template. Download our Five Years Clinical Research Roadmap With Different Phases for excelling at productive management.

Five years clinical research roadmap with drug review

Presenting Five Years Clinical Research Roadmap With Drug Review PowerPoint slide. This PPT presentation is Google Slides compatible hence it is easily accessible. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG.

A well thought out action plan makes execution easier and increases the possibility of success significantly. Ensure hitting all the milestones within the deadlines by introducing our fully customizable Five Years Clinical Research Roadmap With Drug Review. Streamline the work related information, budget, timeframe, key deliverable, landmarks, and major steps involved, all in one place to give an organized overview of the project by utilizing our PowerPoint theme. Minimize time lag and increase work efficiency by providing insight into the process with our comprehensively researched roadmap PowerPoint layout. Color coding helps in highlighting the process and grabs the attention of the audience. Download our handy Five Years Clinical Research Roadmap With Drug Review to identify the possible problem areas in a much shorter time and propose solutions. Have a productive brainstorming session with your workforce by utilizing our action plan visualization tool.

Half yearly clinical research roadmap for human medicine

Presenting Half Yearly Clinical Research Roadmap For Human Medicine PowerPoint Template. This PPT presentation is Google Slides compatible hence it is easily accessible. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements.

Utilize our pre build Half Yearly Clinical Research Roadmap For Human Medicine to present your plan of action in the most effective way. Reduce the paperwork and showcase how different activities are linked to each other by incorporating this attention grabbing PowerPoint theme. This completely editable roadmap PPT layout is suitable to fit all your needs and to have a structured outline of the entire process flow using color coding. Provide guidelines to your teammates about the progression process by employing our PPT theme. Team members can easily be designated into teams by accessing the work milestones to be accomplished within the timeframe. You can easily modify the PowerPoint slide according to real time situations. Download our stunning Half Yearly Clinical Research Roadmap For Human Medicine, and you are good to go to prove your expertise in strategic planning.

Half yearly clinical research roadmap with different phases

Presenting Half Yearly Clinical Research Roadmap With Different Phases PowerPoint slide which is percent editable. You can change the color, font size, font type, and shapes of this PPT layout according to your needs. This PPT template is compatible with Google Slides and is available in both 4,3 and 16,9 aspect ratios. This ready to use PowerPoint presentation can be downloaded in various formats like PDF, JPG, and PNG.

A cohesive work plan is essential for achieving the desired target. Communicate your vision and lay a firm ground in front of your audience with our PowerPoint layout. Align your project milestones, budgets, deliverables, deadlines, and all the requisite information for a dynamic presentation by employing this amazingly designed Half Yearly Clinical Research Roadmap With Different Phases. Maximize team efficiency and streamline a work plan efficiently by introducing our ready made roadmap PowerPoint theme. You can quickly establish coordination between different activities across the organization and present an insight to your colleagues by utilizing this useful business tool. Color code specific tasks, prioritize, and keep a close eye on the deadlines with the help of our eye catchy PowerPoint template. Download our Half Yearly Clinical Research Roadmap With Different Phases for excelling at productive management.

Half yearly clinical research roadmap with drug review

Presenting Half Yearly Clinical Research Roadmap With Drug Review PowerPoint slide. This PPT presentation is Google Slides compatible hence it is easily accessible. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG.

A well thought out action plan makes execution easier and increases the possibility of success significantly. Ensure hitting all the milestones within the deadlines by introducing our fully customizable Half Yearly Clinical Research Roadmap With Drug Review. Streamline the work related information, budget, timeframe, key deliverable, landmarks, and major steps involved, all in one place to give an organized overview of the project by utilizing our PowerPoint theme. Minimize time lag and increase work efficiency by providing insight into the process with our comprehensively researched roadmap PowerPoint layout. Color coding helps in highlighting the process and grabs the attention of the audience. Download our handy Half Yearly Clinical Research Roadmap With Drug Review to identify the possible problem areas in a much shorter time and propose solutions. Have a productive brainstorming session with your workforce by utilizing our action plan visualization tool.

Six months clinical research roadmap for human medicine

Presenting Six Months Clinical Research Roadmap For Human Medicine PowerPoint Template. This PPT presentation is Google Slides compatible hence it is easily accessible. You can download and save this PowerPoint layout in different formats like PDF, PNG, and JPG. This PPT theme is available in both 4,3 and 16,9 aspect ratios. This PowerPoint template is customizable so you can modify the font size, font type, color, and shapes as per your requirements.

Utilize our pre build Six Months Clinical Research Roadmap For Human Medicine to present your plan of action in the most effective way. Reduce the paperwork and showcase how different activities are linked to each other by incorporating this attention grabbing PowerPoint theme. This completely editable roadmap PPT layout is suitable to fit all your needs and to have a structured outline of the entire process flow using color coding. Provide guidelines to your teammates about the progression process by employing our PPT theme. Team members can easily be designated into teams by accessing the work milestones to be accomplished within the timeframe. You can easily modify the PowerPoint slide according to real time situations. Download our stunning Six Months Clinical Research Roadmap For Human Medicine, and you are good to go to prove your expertise in strategic planning.

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Clinical research PowerPoint Presentation Templates and Google Slides

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• Introduction
• Conclusions
• Article Information

BMI indicates body mass index (calculated as the weight in kilograms divided by the height in meters squared); FDA, US Food and Drug Administration; and T2D, type 2 diabetes.

Available weight measurements were captured from baseline through 18 months in 1-month increments. Shaded areas indicate 95% CIs. GLP-1 RA indicates glucagonlike peptide-1 receptor agonists.

Medication indication was categorized based on the brand name and presence of type 2 diabetes (T2D).

eTable 1. Mean Percent Body Weight Change at 1 Year by GLP-1 RA Agent, Indication, and Persistence at 1 Year

eTable 2. Cumulative Distribution of Categorical Weight Loss at 1 Year in the Overall Cohort

eTable 3. Results of the Sensitivity Analysis, After Excluding Patients Who Switched Between the Medications of Interest From the Multivariable Model

eFigure. Cumulative Distribution of Categorical Weight Reduction Percentage at 1 Year Among Patients Who Persisted With the Medications of Interest

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Gasoyan H , Pfoh ER , Schulte R , Le P , Butsch WS , Rothberg MB. One-Year Weight Reduction With Semaglutide or Liraglutide in Clinical Practice. JAMA Netw Open. 2024;7(9):e2433326. doi:10.1001/jamanetworkopen.2024.33326

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One-Year Weight Reduction With Semaglutide or Liraglutide in Clinical Practice

• 1 Center for Value-Based Care Research, Department of Internal Medicine and Geriatrics, Primary Care Institute, Cleveland Clinic, Cleveland, Ohio
• 2 Department of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio
• 3 Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio
• 4 Department of Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio
• 5 Department of Internal Medicine and Geriatrics, Primary Care Institute, Cleveland Clinic, Cleveland, Ohio

Question   What are the observed weight outcomes and the factors associated with clinically meaningful reductions at 1 year in patients with obesity who receive injectable forms of semaglutide or liraglutide in clinical practice?

Findings   In this cohort study of 3389 patients with obesity, the mean percentage of body weight change from baseline to 1 year was −5.1% for semaglutide vs −2.2% for liraglutide treatment; −3.2% for type 2 diabetes vs −5.9% for obesity indications; and −5.5% for patients with persistent medication coverage vs −2.8% with 90 to 275 coverage days and −1.8% with fewer than 90 coverage days. Factors positively associated with achieving at least 10% weight reduction at year 1 included semaglutide (vs liraglutide), obesity as a treatment indication (vs type 2 diabetes), persistent medication coverage, high dosage, and female sex.

Meaning   These findings suggest that future research should focus on identifying the reasons for discontinuation of medication use and interventions aimed at improving long-term persistent coverage.

Importance   Limited data are available on long-term weight loss achieved with semaglutide or liraglutide for type 2 diabetes (T2D) or obesity in clinical practice.

Objective   To document weight loss achieved with injectable forms of semaglutide or liraglutide and identify factors associated with weight reduction of 10% or greater at 1 year.

Design, Setting, and Participants   This retrospective cohort study used electronic health records from a large, integrated health system in Ohio and Florida. Participants included adults with a body mass index (calculated as the weight in kilograms divided by the height in meters squared) of at least 30.0 who initiated treatment with semaglutide or liraglutide between July 1, 2015, and June 30, 2022. Follow-up was completed July 28, 2023.

Exposure   Injectable forms of semaglutide or liraglutide approved for T2D or obesity.

Main Outcomes and Measures   Percentage weight change and categorical weight reduction of 10% or greater at 1 year.

Results   A total of 3389 patients (mean [SD] age, 50.4 [12.2] years; 1835 [54.7%] female) were identified. Of these, 1341 patients received semaglutide for T2D; 1444, liraglutide for T2D; 227, liraglutide for obesity; and 377, semaglutide for obesity. Mean (SD) percentage weight change at 1 year was −5.1% (7.8%) with semaglutide vs −2.2% (6.4%) with liraglutide ( P  < .001); −3.2% (6.8%) for T2D as a treatment indication vs −5.9% (9.0%) for obesity ( P  < .001); and −5.5% (7.5%) with persistent medication coverage (ie, a cumulative gap of less than 90 days) at 1 year vs −2.8% (7.0%) with 90 to 275 medication coverage days and −1.8% (6.7%) with fewer than 90 medication coverage days ( P  < .001). In the multivariable model, semaglutide vs liraglutide (adjusted odds ratio [AOR], 2.19 [95% CI, 1.77-2.72]), obesity as a treatment indication vs T2D (AOR, 2.46 [95% CI, 1.83-3.30]), persistent medication coverage vs 90 medication coverage days (AOR, 3.36 [95% CI, 2.52-4.54]) or 90 to 275 medication coverage days within the first year (AOR, 1.50 [95% CI, 1.10-2.06]), high dosage of the medication vs low (AOR, 1.58 [95% CI, 1.11-2.25]), and female sex (AOR, 1.57 [95% CI, 1.27-1.94]) were associated with achieving a 10% or greater weight reduction at year 1.

Conclusions and Relevance   In this retrospective cohort study of 3389 patients with obesity, weight reduction at 1 year was associated with the medication’s active agent, its dosage, treatment indication, persistent medication coverage, and patient sex. Future research should focus on identifying the reasons for discontinuation of medication use and interventions aimed at improving long-term persistent coverage.

Obesity is a complex chronic disease that represents a significant public health and economic challenge, affecting 42% of the US adult population. 1 It causes or exacerbates the risk of numerous major health complications, such as cardiovascular disease, type 2 diabetes (T2D), cancer, osteoarthritis, and obstructive sleep apnea. 2 Given the medical burden of obesity and the $173 billion in associated annual costs, 3 advances in treatment are of paramount importance.

In the past decade, 2 glucagonlike peptide-1 receptor agonists (GLP-1 RAs) were approved by the US Food and Drug Administration (FDA) for the treatment of obesity: liraglutide (2014) and semaglutide (2021). 4 Additionally, the dual glucose-dependent insulinotropic polypeptide and GLP-1 RA agonist tirzepatide was approved by the FDA for obesity in November 2023. 5 These medications produced clinically meaningful weight reduction in randomized clinical trials. 6 - 8 For example, in the STEP 1 (Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity) study, once-weekly subcutaneous semaglutide, 2.4 mg, plus a lifestyle intervention produced a mean 14.9% reduction in body weight in patients with overweight or obesity (without diabetes) at 68 weeks, compared with a 2.4% weight reduction in the placebo group plus a lifestyle intervention. 6 In the SCALE (Effect of Liraglutide on Body Weight in Non-Diabetic Obese Subjects or Overweight Subjects With Co-Morbidities) trial, once-daily subcutaneous liraglutide, 3.0 mg (plus lifestyle modification), produced a mean 8.0% weight reduction in patients with overweight or obesity (without diabetes) at 56 weeks vs a 2.6% weight reduction in the placebo group. 7 In the STEP 8 trial, which compared once-weekly subcutaneous semaglutide, 2.4 mg, vs once-daily subcutaneous liraglutide, 3.0 mg (both groups also received counseling for diet and physical activity), over 68 weeks, adults with overweight or obesity without diabetes who received semaglutide achieved a mean body weight reduction of 15.8% vs 6.4% with liraglutide. 9

Outside randomized clinical trial settings, data on weight loss with semaglutide or liraglutide for obesity are generally limited to 6 months of follow-up, based on brand names approved by the FDA for T2D only, or cohorts that exclude patients who did not persist with the treatment. 10 - 13 Furthermore, emerging data suggest that persistent coverage with GLP-1 RAs (ie, a cumulative gap of less than 90 days) 14 , 15 is difficult to achieve, but little is known about how persistence affects weight loss. Such understanding could inform the need and scope of future research, as well as clinical and policy interventions aimed at addressing the barriers to the use of these medications. 16 , 17 We examined weight outcomes at 1 year in patients with obesity who received injectable forms of liraglutide or semaglutide and compared outcomes by GLP-1 RA agent, indication, dosage, and persistent coverage with the medication.

Data for this retrospective cohort study were obtained from the Cleveland Clinic electronic health record (EHR) in Ohio and Florida, including linked Surescripts pharmacy dispensation records, 18 from January 1, 2015, to July 28, 2023. The Surescripts prescription data service captures prescriptions paid for via insurance benefits, cash, coupons, or other methods, from nearly all major pharmacies and pharmacy benefit managers in the US. 19

The study was approved by the Cleveland Clinic Institutional Review Board as minimal risk research using data collected for routine clinical practice, for which the requirement for informed consent was waived. The Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guidelines were followed.

We identified adult patients (aged ≥18 years) who filled an initial prescription for injectable semaglutide or liraglutide from July 1, 2015, to June 30, 2022, and had a body mass index (BMI; calculated as the weight in kilograms divided by the height in meters squared) of at least 30.0, recorded on the date of treatment initiation (index date) or during the latest available primary care visit before the index date. To ensure that these were initial fills, we excluded patients prescribed these medications between January 1 and June 30, 2015. Individuals were required to have a follow-up weight measurement at least 12 months after the treatment initiation to be included in the study. Patients who were pregnant, had cancer diagnoses during the study period, or underwent bariatric surgery within 2 years of the initial medication fill were excluded ( Figure 1 ). This study captured fills for injectable forms of semaglutide and liraglutide under the brand names approved by the FDA for obesity (semaglutide, 1.7 or 2.4 mg [Wegovy], and liraglutide, 3.0 mg [Saxenda]), as well as those approved for T2D (semaglutide, 0.5, 1.0, or 2.0 mg [Ozempic], and liraglutide, 1.2 or 1.8 mg [Victoza]), including all starting doses.

The primary outcome measures in this study were (1) percentage of weight change at 1 year following initiation of injectable semaglutide or liraglutide treatment and (2) categorical weight loss of 10% or greater at 1 year, given that sustained weight loss of 10% or more in patients with obesity has a major beneficial impact on obesity-related comorbidities. 20 , 21 Baseline BMI was calculated using the weight data captured on the index date or, if not available, within 6 months before the index date. Body weight at 1 year was determined by the first weight measurement captured between 12 and 18 months. If no weight measurement was available after 12 months, the last weight measurement less than 3 months before the 1-year follow-up time was carried forward; otherwise, the 1-year weight measurement was considered missing. We also captured available weight data from baseline through 18 months (in 1-month increments) to compare the weight trajectories by GLP-1 RA agent. The end of the follow-up period for outcome ascertainment was July 28, 2023.

Medications were classified by their active agent (ie, semaglutide vs liraglutide) and indication (ie, for obesity vs T2D). For individuals who switched between these medications (83 for different brand name or agent in the first vs last fill within the first year), the brand name and active agent were classified based on the medication with the largest number of covered days within the first year. Medication indication was categorized based on the brand name and presence of T2D. Specifically, if a patient received semaglutide or liraglutide with a brand name approved for obesity or a brand name approved for T2D but without a documented diagnosis of T2D (indicating off-label use for obesity), 22 the indication was captured as for obesity; otherwise, the indication was for T2D. The presence of T2D was defined by either a glycated hemoglobin level of at least 6.5% (to convert to proportion of total hemoglobin, multiply by 0.01) or the presence of a diagnostic code for T2D ( International Classification of Diseases, Ninth Revision , code 250.X0 or 250.X2 or International Statistical Classification of Diseases, Tenth Revision, code E11.X). We also created a dichotomous variable for medication maintenance dosage with semaglutide, 1.7, 2.0, or 2.4 mg, and liraglutide, 3.0 mg, classified as high and all other dosages classified as low. The maintenance dosage was determined by the medication fills with the largest number of covered days within the first year. Previous receipt of other antiobesity medication approved by the FDA for chronic weight management (including phentermine-topiramate, naltrexone-bupropion, and orlistat) before the initial fill for liraglutide or semaglutide (index date) was also captured via binary (yes or no) variable.

Persistent coverage with injectable semaglutide and liraglutide use at 1 year was defined as a cumulative gap of less than 90 days within the first year after the initial prescription fill. 14 , 23 Patients who switched between injectable forms of liraglutide and semaglutide but had a cumulative gap of less than 90 days were considered to have persistent coverage at 1 year. We grouped patients with nonpersistent coverage into those who had 90 to 275 medication coverage days within the first year and those who had fewer than 90 medication coverage days.

Sociodemographic variables, including patients’ age, sex, race and ethnicity, primary payer type, and Area Deprivation Index (ADI) based on census block group neighborhood-level data 24 were recorded from the primary care visit closest to the index date. Data on sex and race and ethnicity were based on patient self-report using fixed categories. Race and ethnicity were categorized into Black, Hispanic, White, and other groups (including American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, multiracial, and other); these data were included because they could be associated with both exposure and study outcomes. Area Deprivation Index percentiles were based on a nationwide ranking from 1 to 100, where an ADI with a ranking of 1 indicates the lowest level of disadvantage. 24 Area Deprivation Index rankings were grouped into quartiles. Payer type was categorized as private, Medicare, Medicaid, self-pay, and other. Age-adjusted Charlson Comorbidity Index was also captured from the EHR. 25

Means and SDs were used to summarize normally distributed data, and medians and IQRs were used for data that were not normally distributed. Pearson χ 2 test, 2-sample t test, and Wilcoxon rank sum test were used for comparisons of baseline variables. 26 The mean percentage weight change at 1 year was compared using a 2-sample t test or analysis of variance. 26

A multivariable logistic regression model was used to examine the association of 10% or greater weight loss at 1 year with the following independent variables: GLP-1 RA agent, medication indication, dosage, persistent coverage with GLP-1 RA treatment at 1 year, age, sex, race and ethnicity, primary payer type, ADI quartile, baseline BMI, age-adjusted Charlson Comorbidity Index, and previous use of other antiobesity medications. In the multivariable model, individuals with unknown race and ethnicity, primary payer type, or ADI quartile were included as a separate category. All statistical testing was 2 tailed with α = .05 used to determine statistical significance. All analyses were conducted in R, version 4.2.1, (R Program for Statistical Computing).

To assess the robustness of the identified association between medication and 10% or greater weight loss at 1 year, we conducted sensitivity analysis. For these, we excluded the patients who switched between the medications of interest from the multivariable logistic regression model.

This study included 3389 patients who filled an initial prescription for injectable semaglutide (n = 1718) or liraglutide (n = 1671) from July 1, 2015, to June 30, 2022. Mean (SD) age was 50.4 (12.2) years, and median baseline BMI was 38.5 (IQR, 34.4-44.3). A total of 1853 patients (54.7%) were female and 1536 (45.3%) were male, and 2785 (82.2%) had T2D as a treatment indication. In terms of race and ethnicity, 689 patients (20.3%) were Black, 237 (7.0%) were Hispanic, 2320 (68.5%) were White, and 116 (3.4%) were of other race or ethnicity. Most patients were privately insured (2202 [65.0%]), 631 (18.6%) had Medicare, and 468 (13.8%) had Medicaid as a primary payer; and 958 (28.3%) resided in an area in the most disadvantaged quartile of the ADI ( Table 1 ).

Overall, 1341 patients (39.6%) received semaglutide indicated for T2D, 1444 (42.6%) received liraglutide for T2D, 227 (6.7%) received liraglutide for obesity, and 377 (11.1%) received semaglutide for obesity. Four in 10 patients (1381 [40.7%]) in the overall cohort had persistent medication coverage at 1 year, including 786 (45.8%) receiving semaglutide vs 595 (35.6%) receiving liraglutide ( P  < .001) ( Table 1 ).

Mean (SD) percentage weight change at 1 year was −3.7% (7.3%) in the study cohort; it was −5.1% (7.8%) with semaglutide vs −2.2% (6.4%) with liraglutide ( P  < .001); −3.2% (6.8%) in patients who received the medication for T2D vs −5.9% (9.0%) for obesity ( P  < .001); −5.5% (7.5%) in patients with persistent medication coverage at 1 year vs −2.8% (7.0%) with 90 to 275 medication coverage days within the first year and −1.8% (6.7%) with fewer than 90 medication coverage days ( P  < .001); and −3.5% (7.1%) with a low maintenance dosage vs −6.6% (9.1%) with a high dosage ( P  < .001). Figure 2 presents the mean percentage weight reduction by GLP-1 RA agent from initiation of the medication use during follow-up.

Mean percentage body weight change from baseline to 1 year by medication, indication, and persistence of coverage at 1 year is presented in eTable 1 in Supplement 1 . Notably, among patients with persistent coverage with their medication at year 1 (n = 1381), the mean (SD) percentage reduction in body weight was −12.9% (8.3%) with semaglutide for obesity, −5.9% (7.3%) with semaglutide for T2D, −5.6% (6.9%) with liraglutide for obesity, and −3.1% (6.1%) with liraglutide for T2D.

Figure 3 and eTable 2 in Supplement 1 present the cumulative distribution of categorical percentage of weight reduction in the overall cohort by GLP-1 RA medication and indication. Overall, 141 patients (37.4%) receiving semaglutide for obesity achieved 10% or greater body weight reduction vs 223 (16.6%) of those receiving semaglutide for T2D, 33 (14.5%) of those receiving liraglutide for obesity, and 134 (9.3%) of those receiving liraglutide for T2D. Among patients with persistent medication coverage at year 1, the proportion who achieved at least 10% weight reduction was 86 of 141 (61.0%) receiving semaglutide for obesity, 149 of 645 (23.1%) receiving semaglutide for T2D, 12 of 42 (28.6%) receiving liraglutide for obesity, and 68 of 553 (12.3%) with liraglutide for T2D (eFigure in Supplement 1 ).

In the multivariable model, semaglutide vs liraglutide (adjusted odds ratio [AOR], 2.19 [95% CI, 1.77-2.72]), obesity as a treatment indication vs T2D (AOR, 2.46, 95% CI, 1.83-3.30), persistent coverage for 1 year vs fewer than 90 medication coverage days (AOR, 3.36 [95% CI, 2.52-4.54]) or 90 to 275 medication coverage days (AOR, 1.50 [95% CI, 1.10-2.06]), high vs low dosage of medication (AOR, 1.58 [95% CI, 1.11-2.25]), and female sex (AOR, 1.57 [95% CI, 1.27-1.94]) were positively associated with achieving 10% or greater weight reduction at year 1. A 1-unit increase in baseline BMI was associated with 2% higher odds (AOR, 1.02 [95% CI, 1.01-1.03]) of achieving 10% or greater weight reduction at year 1 ( Table 2 ). These findings were supported by the sensitivity analysis, after excluding 83 patients who switched between the medications of interest from the multivariable model (eTable 3 in Supplement 1 ).

In this large cohort of patients with obesity who initiated treatment with injectable semaglutide or liraglutide, patients lost an average of 3.7% body weight at 1 year. Weight loss varied significantly by the medication, indication, dosage, and persistence of medication coverage. In the multivariable analysis, patients who received semaglutide (vs liraglutide), had a high dosage of the medication (vs low), had obesity (vs T2D) as treatment indication, had persistent medication coverage or 90 to 275 medication coverage days within the first year (vs <90 medication coverage days), had higher baseline BMI, and were female (vs male) had significantly higher odds of achieving 10% or greater weight reduction at 1 year.

Recently, injectable forms of semaglutide have been more commonly prescribed, in part related to their ability to demonstrate clinically meaningful weight outcomes. As a result of its superiority, the demand for the medication has skyrocketed, leading to notable drug shortages. 22 , 27 Patients have high expectations to achieve substantial weight reductions with GLP-1 RA medications. 27 Our clinical findings suggest that this was not the case for most patients in our cohort; however, those who persisted with the medication coverage experienced weight losses comparable with those shown in corresponding clinical trials. 6 , 9 , 28 Unfortunately, only 4 in 10 patients in this cohort had persistent medication coverage at 1 year, which underlines the current challenges with treating T2D and obesity with these highly effective medications. High out-of-pocket costs, insurance coverage–related issues, medication supply shortages, adverse effects, and weight reduction not meeting the patient’s expectations could be the reasons for this, warranting future studies on determinants of nonpersistent coverage with these medications. 14 , 15 However, 61.0% of the patients who received semaglutide for obesity and with persistent coverage at 1 year achieved 10% or greater weight loss, which is only slightly less than the proportion in the STEP 1 study, where 69.1% of participants achieved at least 10% weight reduction at 68 weeks. 6

Patients who received their medication for T2D in this study had significantly lower odds of achieving 10% or greater weight reduction at year 1, compared with those who received it for obesity, after controlling for relevant sociodemographic and clinical factors, including the GLP-1 RA agent, medication dosage, persistent coverage at 1 year, and baseline BMI. The smaller weight reduction for treatment of T2D is consistent with the results of STEP 1 and STEP 2 studies in which the placebo-adjusted mean weight reduction in patients with overweight or obesity with semaglutide, 2.4 mg, was 12.5% in those without T2D (STEP 1) vs 6.2% with T2D (STEP 2) at 68 weeks. 6 , 28 Potential explanations include background diabetes medications that could promote weight gain, hyperinsulinemia, altered microbiota or genetic predisposition, and a decrease in glycosuria in patients with T2D. 29

Furthermore, receipt of a higher dose of semaglutide or liraglutide and female sex were positively associated with a 10% or greater weight reduction at year 1. This is consistent with subgroup analyses of STEP clinical trials, 30 as well as observational data among individuals prescribed semaglutide dosages of 0.25 to 2.0 mg/wk, 31 but the mechanisms underlying this discrepancy are unknown. Our findings provide timely data on longer-term weight outcomes in patients receiving treatment with injectable semaglutide or liraglutide for obesity or T2D and identify key characteristics that could inform the probability of achieving sustained weight loss of a magnitude large enough to provide clinically significant health benefits. 20 , 21

Strengths of this study include its large and diverse sample (including 20.3% Black and 7.0% Hispanic individuals) comprising multiple years of data, integration of prescription dispensation data from Surescripts with clinical information, 19 , 32 and inclusion of all patients who received the medication, whether or not they achieved persistent coverage. This study also has some limitations. The present study used data from EHRs, including Surescripts dispensed prescription data, and included adult patients in Ohio and Florida in a single large integrated health system. Patient characteristics and health care delivery patterns may vary across the US, which may limit the generalizability of our findings. During the study period, shortages of semaglutide were reported, which could have limited the ability of patients to continuously access the medication. Some of the recorded weight loss achieved may be associated with other interventions (eg, lifestyle interventions and nutritional counseling); nevertheless, the studied medications have been approved to be used in addition to diet and exercise. This study did not capture concomitant medications that are known to affect body weight, such as insulin, or attendance to lifestyle interventions and nutritional counseling. Our database did not capture patient- and clinician-related factors (such as discontinuation of the medication therapy due to inadequate blood glucose level control, weight reduction, adverse effects, or coverage issues), 16 , 33 and these could not be examined in this study. Furthermore, using the EHR data might have increased susceptibility to coding errors.

In this retrospective cohort study of 3389 patients with obesity treated with injectable forms of semaglutide or liraglutide in a regular clinical setting, achieving sustained weight reduction of 10% or more was associated with the GLP-1 RA agent, treatment indication, medication dosage, sex, and persistence with medication coverage. Future research should focus on identifying the reasons for discontinuation of medication use and interventions aimed at improving long-term persistent coverage.

Accepted for Publication: July 18, 2024.

Published: September 13, 2024. doi:10.1001/jamanetworkopen.2024.33326

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Gasoyan H et al. JAMA Network Open .

Corresponding Author: Hamlet Gasoyan, PhD, Center for Value-Based Care Research, Department of Internal Medicine and Geriatrics, Primary Care Institute, Cleveland Clinic, 9500 Euclid Ave, G10, Cleveland, OH 44195 ( [email protected] ).

Author Contributions: Dr Gasoyan had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design : Gasoyan, Rothberg.

Acquisition, analysis, or interpretation of data : All authors.

Drafting of the manuscript : Gasoyan.

Critical review of the manuscript for important intellectual content : Pfoh, Schulte, Le, Butsch, Rothberg.

Statistical analysis : Schulte, Le.

Administrative, technical, or material support : Gasoyan, Pfoh.

Supervision : Gasoyan, Rothberg.

Conflict of Interest Disclosures: Dr Gasoyan reported receiving grant funding from the National Cancer Institute outside the submitted work. Dr Butsch reported advisory board fees from Novo Nordisk A/S and research funding from Eli Lilly and Co during the conduct of the study. Dr Rothberg reported receiving personal fees from the Blue Cross Blue Shield Association outside the submitted work. No other disclosures were reported.

Data Sharing Statement: See Supplement 2 .

Additional Contributions: Oleg Lisheba, MS, from the Department of Data and Analytics, Cleveland Clinic, created the database, for which he did not receive additional compensation.

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