[Skip to Content]
[Skip to Content Landing]

Preserving Clinical Trial Integrity During the Coronavirus Pandemic

Educational Objective
Review the challenges in performing RCTs during the Coronavirus pandemic
1 Credit CME

Randomized clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier lives. As of March 2020, ClinicalTrials.gov listed 262 366 ongoing randomized clinical trials, including 146 420 trials studying drug or biologic interventions, 85 045 trials of behavioral interventions, and 61 351 trials of surgical or device interventions.1 Suddenly, and quite dramatically, the coronavirus pandemic threatens the integrity of these clinical trials. The National Institutes of Health has advised investigators to consult with their institutional review boards and institutions about potential measures to protect participants and research staff. Responses from academic medical center and other research groups have varied from mandatory suspension of research involving human participants (except when this increases risk to participants) to relying on principal investigator discretion.

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

Article Information

Corresponding Author: Mary M. McDermott, MD, Department of Medicine, Feinberg School of Medicine, Northwestern University, 750 N Lake Shore Dr, 10th Floor, Chicago, IL 60611 (mdm608@northwestern.edu).

Published Online: March 25, 2020. doi:10.1001/jama.2020.4689

Conflict of Interest Disclosures: Dr McDermott reported receiving grants from the National Heart, Lung, and Blood Institute, National Institute on Aging, American Heart Association, and Regeneron; financial support for intervention for clinical trials from Helixmith, Hershey, Chromadex, ArtAssist, and ReserveAge; and nonfinancial support from Mars Inc. Dr Newman reported no disclosures.

References
1.
Trends, charts, and maps. ClinicalTrials.gov. Accessed March 16, 2020. https://clinicaltrials.gov/ct2/resources/trends
2.
Pahor  M, Guralnik  JM, Ambrosius  WT,  et al; LIFE Study Investigators.  Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial.  JAMA. 2014;311(23):2387-2396. doi:10.1001/jama.2014.5616PubMedGoogle ScholarCrossref
3.
FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic: guidance for industry, investigators, and institutional review boards. US Food and Drug Administration. Published March 2020. Accessed March 18, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close