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