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Conducting Clinical Research During the COVID-19 PandemicProtecting Scientific Integrity

Educational Objective
To understand how to conduct clinical research during COVID-19
1 Credit CME

The current novel coronavirus disease 2019 (COVID-19) pandemic has led to substantial changes in health risks, access to health care, and daily interactions. Through these and other challenges, the pandemic is affecting ongoing clinical trials that are evaluating interventions aimed at preventing or treating diseases other than COVID-19. Meaningful alterations to the implementation of protocol-specified procedures for adherence and retention of study participants, without careful consideration of the consequences to statistical analysis, can compromise the generalizability of clinical trial results about efficacy and safety of studied interventions in the postpandemic setting.

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Article Information

Corresponding Author: Thomas R. Fleming, PhD, Department of Biostatistics, University of Washington, PO Box 357232, Seattle, WA 98195-7232 (tfleming@uw.edu).

Published Online: May 28, 2020. doi:10.1001/jama.2020.9286

Conflict of Interest Disclosures: Dr Fleming reported receiving support from the National Institutes of Health and Bristol Myers Squibb, and having extensive interactions in coronavirus disease 2019 (COVID-19) research with the World Health Organization Research and Development Working Group. Dr Labriola reported receiving support from Global Drug Development/Biometrics and Data Sciences of Bristol Myers Squibb. Dr Wittes reported that her employer (Statistics Collaborative) has contracts for statistical collaborations with many companies that have ongoing studies potentially affected by the COVID-19 pandemic.

References
1.
US Food and Drug Administration.  FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards. March 2020 (updated May 14, 2020). US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Good Clinical Practice. Accessed May 21, 2020. Docket No. FDA-2020-D-1106. https://www.fda.gov/media/136238/download
2.
European Medicines Agency.  Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. European Medicines Agency. March 20, 2020 (updated April 28, 2020). Accessed May 21, 2020. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
3.
Bauchner  H , Fontanarosa  PB .  Randomized clinical trials and COVID-19: managing expectations.   JAMA. Published online May 4, 2020. doi:10.1001/jama.2020.8115PubMedGoogle Scholar
4.
McDermott  MM , Newman  AB .  Preserving clinical trial integrity during the coronavirus pandemic.   JAMA. Published online March 25, 2020. doi:10.1001/jama.2020.4689PubMedGoogle Scholar
5.
Panel on Handling Missing Data in Clinical Trials, Committee on National Statistics, Division of Behavioral and Social Sciences and Education, National Research Council of the National Academies.  The Prevention and Treatment of Missing Data in Clinical Trials. National Academies Press; 2010.
6.
Fleming  TR .  Addressing missing data in clinical trials.   Ann Intern Med. 2011;154(2):113-117. doi:10.7326/0003-4819-154-2-201101180-00010PubMedGoogle ScholarCrossref
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