FDA Updates Clinical Trial Guidance, Addressing Adverse Event Reporting
Sponsors and sites conducting non-COVID-19 research should use an independent data monitoring committee to determine whether serious adverse events (SAE) are caused by the COVID-19 virus or by the investigational drug before submitting a safety report to the FDA, according to an update to the agency’s guidance on conducting clinical trials during the COVID-19 crisis.
The guidance acknowledges that trial participants may become infected for reasons unrelated to the investigational drug and says only those SAEs that can be attributed to the drug itself need to be reported.
Sponsors of already-approved drugs being tested for use against COVID-19 also must report SAEs if they determine the drug caused the event, according to this third update to the guidance the FDA first issued in March. Previous updates were released in April and May (CenterWatch Weekly, May 18).
To read the guidance, click here: https://bit.ly/30d5fDa.