FDA Releases Statistical Guidance for Clinical Trials Affected by COVID-19

The FDA has released new guidance regarding statistical considerations for clinical trials affected by the COVID-19 pandemic, with the aim of maintaining integrity of trial data.

Since March 2020, the agency has been continuously updating guidelines on conducting trials amid the health crisis to protect patients.

“To help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty, this guidance addresses statistical considerations for proposed changes to trial conduct due to the COVID-19 pandemic that may impact the analysis and interpretation of the primary or key secondary endpoints in the trial,” the FDA wrote in its report.

The guidance recommends points to consider when modifying trials to address COVID-19-related issues, including summaries of pooled data over treatment arms, endpoint adjustments, site closures, or supply disruptions. The report also provides design and analysis strategies for evaluating primary and key secondary endpoints in trials that were impacted by the pandemic.

The FDA also offers recommendations at the participant level, such as treatment discontinuation, participant trial withdrawal, and use of alternative treatments.

Other issues addressed in the guidance include how to handle loss of statistical power due to smaller sample sizes, how to approach statistical analyses in prematurely ended trials, suggestions for increasing enrollment after the pandemic, and how to determine if modifications to primary and key secondary endpoints are necessary. The guidance is available through the FDA’s website.

Sources: Endpoints, June 18, 2020; FDA Guidance for Industry, June 2020.