Former FDA regulators: TrialBlazer will speed up IND review, but the first patient must still wait for site activation and ethics approval

TrialBlazer speeds up IND submission, but the first participant must still wait for the clinical site to open

On June 22, the US Department of Health and Human Services launched Operation TrialBlazer, an interagency program intended to accelerate early-stage clinical trials. The FDA, the US drug regulator, proposed allowing companies to submit IND applications in stages before beginning human trials of a drug. On August 3, former FDA officials explained to BioSpace why a study must still wait for a clinical site to open after the IND process is complete. The site is the hospital or research center that enrolls participants.

Harpreet Singh, former head of the FDA's oncology division, described what happens after IND review:

“Most delays in early-stage trials occur not at the FDA, but at the site level.”

Before enrollment can begin, the site must obtain ethics committee approval, negotiate a contract and budget with the sponsor, collect investigator documents, train the study team, and receive the drug. A participant can then sign the informed consent form and attend the first visit.

In a multicenter study, the same protocol goes to several clinics. Each clinic may submit it to its own ethics committee and negotiate its contracts and budget independently. A 2020 review of 89 studies on the initiation of global phase III trials described the same sequence of delays. In one study involving 57 centers across 16 countries, contracts with US sites took an average of 7.9 months to finalize.

The FDA is considering a single ethics committee for all sites within one program. This committee would review the common protocol once, instead of requiring the protocol to undergo a separate review at every clinic. Dave Peneyk, CEO of the biotechnology company Saol Therapeutics, estimated the potential effect as follows:

“Ethics committees cause substantial delays because each organization adds its own protocol requirements. A single central committee could eliminate six to twelve months.”

A single committee would accelerate only the repeated review of the protocol. Each site would still need to complete its contracts, budget negotiations, team preparation, and recruitment setup before opening enrollment.