COVID-19 Master Protocol Trial Participants Should Be Randomized, FDA Says

Sponsors using master protocols to test new drugs and therapies for treating or preventing COVID-19 should base their analyses on comparisons between control arm participants who were concurrently randomized, the FDA advised in a final guidance released yesterday.

The agency noted that master protocols can save drugmakers time and money in study startup and can accelerate drug development by evaluating multiple drugs at the same time and maximizing the amount of information gained during research, compared to stand-alone trials.

Acting FDA Commissioner Janet Woodcock, a vocal proponent of master protocols, said the agency “expects master protocols to continue to play an important role in addressing the public health needs created by the pandemic and in generating clinical evidence in general.”

The FDA advised sponsors to meet with the agency before making a change where a drug evaluated under a master protocol is incorporated into a trial as either a background therapy or as part of the control arm. The agency also advised sponsors to meet to discuss endpoint selection in cases where drugs intended to affect different aspects of a disease — such as anticoagulants and antivirals — may have multiple endpoints specific to the intervention.

The agency said it may be appropriate, under certain circumstances, for sponsors to take a selective approach to safety data collection for repurposed drugs being studied for use against COVID-19.

If some participants are only eligible for some treatment arms in a trial, they should only be compared to other control arm participants who were eligible for that treatment arm, the FDA said.

The agency also urged sponsors to avoid widespread dissemination of results for one investigational drug because it could potentially affect the conduct and integrity of trials evaluating other drugs.

Read the guidance here: www.fdanews.com/05-17-21-COVID-19.pdf. — Charlie Passut