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# Covid Trial Statistical Considerations Guidance
- URL: https://www.fdaweb.com/covid-trial-statistical-considerations-guidance/
- Published: 2020-06-17T12:00:00.000Z
- Updated: 2026-09-14T16:18:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147025

FDA has issued an immediately-in-effect guidance, *Statistical Considerations for Clinical Trials During the Covid-19 Public Health Emergency*, to address the impact of Covid-19 on meeting trial objectives for clinical trials conducted during the duration of the public health emergency. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-considerations-clinical-trials-during-covid-19-public-health-emergency-guidance-industry?ref=fdaweb.com) outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by Covid-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

The agency says the guidance addresses statistical considerations for proposed changes to trial conduct that may affect the analysis and interpretation of the primary or key secondary endpoints in the trial. “FDA recommends that sponsors consult with the relevant FDA review division when considering protocol changes and changes to the statistical an analysis plan that may impact the analysis and interpretation of these endpoints,” the guidance says. The document covers trial integrity and trial mitigation and analysis strategies.