Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic

TL;DR

This paper discusses the unique statistical challenges faced by clinical trials during COVID-19 and proposes strategies to address issues like missing data and analysis validity to ensure reliable results.

Contribution

It provides specific recommendations and strategies for handling statistical issues in COVID-19-affected clinical trials, enhancing their validity and interpretability.

Findings

Strategies for handling missing data

Recommendations for analysis modifications

Guidelines for trial interpretability

Abstract

The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. A number of strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability.