There aren’t too many bipartisan things happening on Capitol Hill these days, but a new U.S. Senate bill designed to speed clinical trials appears to be one of them.
As introduced earlier this month, the Enhanced Clinical Trial Design Act would mandate a public meeting between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to analyze and discuss potential new criteria for clinical trials.
The bill addresses an issue long overdue for attention, said one of the bill’s co-sponsors, Utah Senator Orrin Hatch. “The long clinical trial and evaluation process prevents many Americans from getting the care they need when they need it,” Hatch was quoted saying on Utahpolicy.com. “What’s worse, the cumbersome process discourages high-risk patients from enrolling in clinical trials, even though these are the very patients who need the treatments most.”
Hatch said the bill was designed to correct these and other shortcomings by giving drug manufacturers and sponsors suggestions on how to broaden eligibility for clinical trials. It should also “improve medical treatments by encouraging manufacturers to recruit more high-risk patients in their clinical trials. With more comprehensive data, manufacturers will be better equipped to develop drug treatments that offer hope and relief to thousands of Americans.”
The bill would also mandate the Government Accountability Office to produce a study outlining any potential problems the proposed expansion would create for industry.
The bill would revise the institutional review board (IRB) assessment process for individual pediatric and adult patient expanded access trial protocols, by giving the IRB more authority when evaluating and monitoring such trials.
In some cases, including for drugs going through the FDA’s Breakthrough Therapy pathway, drug makers would be given the option to make details of their policies available to regulators during Phase I of a study instead of waiting for Phase II or III.
In addition to Hatch, the bill is sponsored by Michael Bennet (D-Colo.), Richard Burr (R-N.C.), and Bob Casey (D-Pa.).
Author: Michael Causey