July 7, 2020, Vol 324, No. 1, Pages 7-110
Conducting Clinical Research During the COVID-19 Pandemic – Protecting Scientific Integrity
Thomas R. Fleming, PhD; Dominic Labriola, PhD; Janet Wittes, PhD
JAMA. 2020;324(1):33-34. doi:10.1001/jama.2020.9286
This Viewpoint discusses procedures to ensure the safety of RCT participants without sacrificing the validity of trials conducted during the COVID-19 pandemic, including home-based test drug administration and outcome measurement, prespecifying stopping rules for pandemic-related interruptions, and stratifying analyses by pandemic-imposed differences in study conduct.