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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.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

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
AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

  • 1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
  • 1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
  • 1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
  • 1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
  • 1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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