FDA Seeks Industry Feedback on EID Clinical Trial Designs

In the wake of the 2014 Ebola outbreak, the FDA is weighing the best options for testing and rapidly deploying treatments for emerging infectious diseases and wants to hear from you on the subject.

In a Federal Register notice, the FDA has asked for industry feedback on developing clinical trials that can rapidly examine therapies for EIDs, to ensure an equally speedy treatment roll-out.

The examination of the issue stems from 11 cases of Ebola in the U.S. last fall that sparked widespread fear and shined a spotlight on the difficulty physicians had gaining access to experimental Ebola treatments.

To avoid similar issues in the future, the FDA held a November workshop — alongside the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Diseases and the CDC — to consider the “ethical and methodological assumptions behind the choice of different trial designs,” as well as to “explore several clinical trial designs for both vaccines and therapeutic products,” according to the notice.

Now, the federal bodies want input from industry, academics and other stakeholders on the subject, with a particular focus on the “the scientific, ethical, and practical considerations that should be taken into account when designing and implementing clinical trials for future emerging infectious diseases in resource-limited settings.”

To comment on the topic, go to www.regulations.gov and enter “FDA-2015-N-4170” in the search field.

The Federal Register notice is available here: www.fdanews.com/12-29-15-Clinical.pdf.