A new tool from the NIH Collaboratory assists investigators in identifying impacts of the COVID-19 public health emergency on ongoing pragmatic clinical trials. The Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts summarizes impacts on trial conduct that study teams should document, measure, analyze, and report.

The new checklist was developed by the NIH Collaboratory’s Biostatistics and Study Design Core Working Group. Since the beginning of the COVID-19 pandemic, many of the NIH Collaboratory Trials have had to postpone recruitment, alter methods of participant engagement, and modify tools for research assessment and intervention delivery.

The leaders of the Biostatistics Core, Dr. Patrick Heagerty and Dr. Liz Turner, spoke in a recent interview about the impacts of the pandemic on the NIH Collaboratory Trials. Early next year, the Coordinating Center will report the results of a survey of the study teams about their experiences with these impacts.

Download the Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts.