Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency

FDA has issued a Guidance for Industry entitled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”

This guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. 

Both clinical development and ongoing clinical trials across investigational product areas haven been impacted during the COVID-19 pandemic. 

Public health measures to control the virus may impact the ability to collect data, for example, if trial participants are not able to visit clinical sites for endpoint assessments. 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.

In accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)), this guidance will remain in effect only during the public health emergency related to COVID-19 as declared by the Secretary of Health and Human Services (HHS), January 31, 2020, effective January 27, 2020.  

The guidance addresses the following:

  • Trial Integrity
    • to address the impact of COVID-19 on the ability to meet the trial objectives
    • to address the impact of COVID-19 when considering modifications to the trial
    • Appropriate participant data to consider when making modifications to the trial
  • Trial Mitigation and Analysis Strategies to address the impact of COVID-19 on evaluating the primary and key secondary endpoints of the trial.  
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Last Updated: 2020-06-17

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