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
June3, 2024
Derek C.Angus,MD, MPH1,2; Alison J.Huang,MD, MAS3; Roger J.Lewis,MD, PhD1,4; et al Amy P.Abernethy,MD, PhD5,6; Robert M.Califf,MD7; MartinLandray,PhD8,9; NancyKass,ScD10; KirstenBibbins-Domingo,PhD, MD, MAS1,3; for the JAMA Summit on Clinical Trials Participants
Author Affiliations Article Information
-
1JAMA, Chicago, Illinois
-
2University of Pittsburgh Schools of the Health Sciences, Pittsburgh, Pennsylvania
-
3University of California, San Francisco
-
4David Geffen School of Medicine at UCLA, Los Angeles, California
-
5Verily Life Sciences, San Francisco, California
-
6Now with Highlander Health, Dallas, Texas
-
7US Food and Drug Administration, Washington, DC
-
8Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom
-
9Protas, Manchester, United Kingdom
-
10Johns Hopkins University, Baltimore, Maryland
JAMA. Published online June 3, 2024. doi:10.1001/jama.2024.4088
JAMA Summit
- Editorial Introducing the JAMA Summit
KirstenBibbins-Domingo,PhD, MD, MAS; Derek C.Angus,MD, MPH; HannahPark; Roger J.Lewis,MD, PhD; RohanKhera,MD, MS; JenniferZeis; AnnetteFlanagin,RN, MA; GregoryCurfman,MD
JAMA
- Editor's Note Integrating Clinical Trials and Practice
GregoryCurfman,MD
JAMA
- Viewpoint Why Should the FDA Focus on Pragmatic Clinical Research?
Ali B.Abbasi,MD; Lesley H.Curtis,PhD; Robert M.Califf,MD
JAMA
Audio (18:38)
Integrating Clinical Trials With the Practice of Medicine
1x
0:00 / 0:00
Subscribe to Podcast
Full Text
Abstract
Importance Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine’s ability to best serve society.
Observations In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale.
Conclusions and Relevance The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation—the clinical trials and health care delivery enterprises—operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.
- Editorial Introducing the JAMA Summit
JAMA
- Editor's Note Integrating Clinical Trials and Practice
JAMA
Full Text
Add or change institution
Read More About
Health Care Quality Health Care Delivery Models Ethics Equity, Diversity, and Inclusion
Citation
Angus DC, Huang AJ, Lewis RJ, et al. The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided. JAMA. Published online June 03, 2024. doi:10.1001/jama.2024.4088
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