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

Wednesday, June 17, 2020   (0 Comments)
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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry

 

Guidance for Industry

JUNE 2020

Yesterday, the FDA announced the availability of a CDER Office of Biostatistics-led guidance entitled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”CDER Office of Biostatistics worked with the CDER Office of New Drugs and with CBER, CDRH, and CVM to draft and clear this guidance.

 

The COVID-19 pandemic has impacted clinical development and ongoing clinical trials across medical product areas. 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.FDA recommends that sponsors consult with the relevant FDA review division when considering protocol changes and changes to the statistical analysis plan that may impact the analysis and interpretation of these endpoints.

 

To learn more about statistical considerations for clinical trials impacted by COVID-19, read the guidance available at the following link:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-considerations-clinical-trials-during-covid-19-public-health-emergency-guidance-industry.

Issued by:

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Veterinary Medicine


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