Drug companies are currently not required to submit protocols for late-stage clinical trials to the FDA. However, some researchers believe that this should change. They argue that FDA guidance during Phase III trials would enhance protocol quality and ultimately provide more accurate data. The FDA may help determine if a clinical trial is large enough and if it will run long enough. About 20% of drug makers submitting a new drug for review did not seek FDA review. However, not everyone agrees with requiring special protocol assessments (SPA). Although one researcher finds the review process useful, it can also be frustrating:
“The quality of FDA recommendations is variable, depending on the review division and reviewers,” Steve Nissen, who chairs the cardiovascular medicine department at the Cleveland Clinic Foundation, writes us. “A protocol can go through several cycles of review, which may slow down drug development.
“Clinical trials ‘designed by committee’ are not always better than studies designed by a small group of thoughtful experts… There may be opportunities for sponsors to innovate in trial design, which involves taking regulatory risk, but can advance the field when such innovations succeed. If we only take safe and proven pathways, we don’t optimize innovation.”
One company currently testing their product in late-stage trials has recently received FDA agreement on their protocol design. The FDA has found that the phase III trial of Starpharma’s VivaGel has adequate design, endpoints, and statistical analyses. The FDA SPA agreement follows approval of Starpharma’s phase III trials by the European Medicines Agency (EMA).
Should Drug Makers be Required to Take FDA Advice on Pivotal Trials?
FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase 3 Recurrent BV Trial
