Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy|Continue
JAMA
Sign In
Individual Sign In
Sign inCreate an Account
Access through your institution
Sign In
New Online
Special Communication
Integrating Clinical Trials and Practice
August5, 2024
Joseph B.Franklin,JD, PhD1; CarolineMarra,PhD1; Kaleab Z.Abebe,PhD2; et al Atul J.Butte,MD, PhD3,4; Deborah J.Cook,MD5; LauraEsserman,MD, MBA6; Lee A.Fleisher,MD7; Cynthia I.Grossman,PhD8; Nancy E.Kass,ScD9; Harlan M.Krumholtz,MD, SM10; KathyRowan,PhD11,12; Amy P.Abernethy,MD, PhD13; for the JAMA Summit on Clinical Trials Participants
Author Affiliations Article Information
-
1Verily Life Sciences, South San Francisco, California
-
2Center for Biostatistics & Qualitative Methodology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
-
3Bakar Computational Health Sciences Institute, University of California, San Francisco
-
4Center for Data-Driven Insights and Innovation, University of California Health, Oakland
-
5Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada
-
6Departments of Surgery and Radiology and Institute for Health Policy Studies, University of California, San Francisco
-
7Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia
-
8Biogen, Boston, Massachusetts
-
9Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
-
10Yale University School of Medicine, New Haven, Connecticut
-
11National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Programme, London, United Kingdom
-
12Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom
-
13Highlander Health, Dallas, Texas
JAMA. Published online August 5, 2024. doi:10.1001/jama.2024.0268
Full Text
Abstract
Importance The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated.
Observations Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure.
Conclusions and Relevance We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal.
Full Text
Add or change institution
Read More About
Research, Methods, Statistics Ophthalmology Neonatology Pediatrics Reproductive Health
Citation
Franklin JB, Marra C, Abebe KZ, et al. Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence. JAMA. Published online August 05, 2024. doi:10.1001/jama.2024.0268
Manage citations:
Ris (Zotero) EndNote BibTex Medlars ProCite RefWorks Reference Manager Mendeley
© 2024
Add or change institution
Artificial Intelligence ResourceCenter
Others Also Liked
Select Your Interests
Customize your JAMA Network experience by selecting one or more topics from the list below.
- Academic Medicine
- Acid Base, Electrolytes, Fluids
- Allergy and Clinical Immunology
- American Indian or Alaska Natives
- Anesthesiology
- Anticoagulation
- Art and Images in Psychiatry
- Artificial Intelligence
- Assisted Reproduction
- Bleeding and Transfusion
- Cardiology
- Caring for the Critically Ill Patient
- Challenges in Clinical Electrocardiography
- Climate and Health
- Climate Change
- Clinical Challenge
- Clinical Decision Support
- Clinical Implications of Basic Neuroscience
- Clinical Pharmacy and Pharmacology
- Complementary and Alternative Medicine
- Consensus Statements
- Coronavirus (COVID-19)
- Critical Care Medicine
- Cultural Competency
- Dental Medicine
- Dermatology
- Diabetes and Endocrinology
- Diagnostic Test Interpretation
- Drug Development
- Electronic Health Records
- Emergency Medicine
- End of Life, Hospice, Palliative Care
- Environmental Health
- Equity, Diversity, and Inclusion
- Ethics
- Facial Plastic Surgery
- Gastroenterology and Hepatology
- Genetics and Genomics
- Genomics and Precision Health
- Geriatrics
- Global Health
- Guide to Statistics and Methods
- Guidelines
- Hair Disorders
- Health Care Delivery Models
- Health Care Economics, Insurance, Payment
- Health Care Quality
- Health Care Reform
- Health Care Safety
- Health Care Workforce
- Health Disparities
- Health Inequities
- Health Policy
- Health Systems Science
- Hematology
- History of Medicine
- Humanities
- Hypertension
- Images in Neurology
- Implementation Science
- Infectious Diseases
- Innovations in Health Care Delivery
- JAMA Infographic
- Law and Medicine
- Leading Change
- Less is More
- LGBTQIA Medicine
- Lifestyle Behaviors
- Medical Coding
- Medical Devices and Equipment
- Medical Education
- Medical Education and Training
- Medical Journals and Publishing
- Melanoma
- Mobile Health and Telemedicine
- Narrative Medicine
- Nephrology
- Neurology
- Neuroscience and Psychiatry
- Notable Notes
- Nursing
- Nutrition
- Nutrition, Obesity, Exercise
- Obesity
- Obstetrics and Gynecology
- Occupational Health
- Oncology
- Ophthalmology
- Orthopedics
- Otolaryngology
- Pain Medicine
- Palliative Care
- Pathology and Laboratory Medicine
- Patient Care
- Patient Information
- Pediatrics
- Performance Improvement
- Performance Measures
- Perioperative Care and Consultation
- Pharmacoeconomics
- Pharmacoepidemiology
- Pharmacogenetics
- Pharmacy and Clinical Pharmacology
- Physical Medicine and Rehabilitation
- Physical Therapy
- Physician Leadership
- Poetry
- Population Health
- Primary Care
- Professional Well-being
- Professionalism
- Psychiatry and Behavioral Health
- Public Health
- Pulmonary Medicine
- Radiology
- Regulatory Agencies
- Reproductive Health
- Research, Methods, Statistics
- Resuscitation
- Rheumatology
- Risk Management
- Scientific Discovery and the Future of Medicine
- Shared Decision Making and Communication
- Sleep Medicine
- Sports Medicine
- Stem Cell Transplantation
- Substance Use and Addiction Medicine
- Surgery
- Surgical Innovation
- Surgical Pearls
- Teachable Moment
- Technology and Finance
- The Art of JAMA
- The Arts and Medicine
- The Rational Clinical Examination
- Tobacco and e-Cigarettes
- Toxicology
- Translational Medicine
- Trauma and Injury
- Treatment Adherence
- Ultrasonography
- Urology
- Users' Guide to the Medical Literature
- Vaccination
- Venous Thromboembolism
- Veterans Health
- Violence
- Women's Health
- Workflow and Process
- Wound Care, Infection, Healing
Save Preferences
Privacy Policy | Terms of Use
X
.
Access your subscriptions
Add or change institution
Free access to newly published articles
To register for email alerts, access free PDF, and more
Purchase access
Get full journal access for 1 year
Get unlimited access and a printable PDF ($40.00)—
Sign in or create a free account
Rent this article from DeepDyve
Access your subscriptions
Add or change institution
Free access to newly published articles
To register for email alerts, access free PDF, and more
Purchase access
Get full journal access for 1 year
Get unlimited access and a printable PDF ($40.00)—
Sign in or create a free account
Rent this article from DeepDyve
Sign in to access free PDF
Add or change institution
Free access to newly published articles
To register for email alerts, access free PDF, and more
Save your search
Free access to newly published articles
To register for email alerts, access free PDF, and more
Purchase access
Customize your interests
Free access to newly published articles
To register for email alerts, access free PDF, and more
Create a personal account or sign in to:
- Register for email alerts with links to free full-text articles
- Access PDFs of free articles
- Manage your interests
- Save searches and receive search alerts
Privacy Policy
Make a comment
Free access to newly published articles
To register for email alerts, access free PDF, and more
Create a personal account or sign in to:
- Register for email alerts with links to free full-text articles
- Access PDFs of free articles
- Manage your interests
- Save searches and receive search alerts
Privacy Policy
