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.
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 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.