Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry
Guidance for Industry
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.
BioFlorida is the voice of Florida's life sciences industry, representing 6,700 establishments and research organizations in the BioPharma, MedTech, HealthIT & BioAg that collectively employ nearly 94,000 Floridians.