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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.
Recent guidance from the US Food and Drug Administration1 urges sponsors of clinical trials to be “assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing the risks to trial integrity during the COVID-19 pandemic.” To achieve these goals, trialists should identify activities that do not place study participants at increased risk of COVID-19 due to study-specific procedures. While ensuring safety, trials should achieve timely recruitment, proper adherence to protocol-specified procedures, high retention of participants, and proper statistical analyses to avoid undue loss of statistical power and increased risk of bias due to informative missing data. This Viewpoint discusses procedures that would “ensure the rights, safety and wellbeing of participants,”2 while mitigating risks to trial integrity.
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Fleming TR, Labriola D, Wittes J. Conducting Clinical Research During the COVID-19 Pandemic: Protecting Scientific Integrity. JAMA. 2020;324(1):33–34. doi:10.1001/jama.2020.9286
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