USA – FDA guidance offers statistical advice for clinical trials

The US Food and Drug Administration (FDA) on Wednesday issued immediately effectivguidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial integrity and mitigating the effects of coronavirus disease (COVID-19) public health emergency on clinical trials.
 
The new document follows the agency’s guidance on the conduct of clinical trials amid the pandemic, which has been updated several times to include additional questions and answers since being issued in March. (RELATED: FDA unveils guidance for trials impacted by COVID-19Regulatory Focus 18 March 2020; FDA updates guidance on clinical trials amid COVID-19Regulatory Focus 13 May 2020).
 
Guidance
 
While the agency’s clinical trial conduct guidance has focused on ways to protect patients and mitigate the effects of COVID-19, the new statistical considerations guidance is meant to help sponsors with statistical considerations for changes to a trial…