THE RELATIONSHIP THAT A SPONSOR COMPANY HAS WITH A REGULATOR IS VERY IMPORTANT. If you build a good relationship, that will help in the creation of a strong regulatory and clinical strategy. The FDA will make recommendations and guide developers on what, minimally, should go into a trial protocol, which helps an organization ask the questions it wants the trial to answer.
In addition, the FDA has come a long way in its approach to clinical trial protocol designs. The FDA’s Complex Innovative Trial Design Paired Meeting Program, for example, is looking at using different methodologies for evaluating trial data, including adaptive designs and Bayesian statistical analyses, which can add complexity to a clinical program. Fortunately, the FDA has been very supportive in trying to figure out ways to work with sponsor companies. Hybrid approaches for certain later-stage trials may prevent developers from conducting two parallel controlled trials, as has been done historically. One trial maybe be sufficient based on Phase 2 data, in some cases. Working effectively with the FDA becomes a collaborative effort to determine what is acceptable and necessary and what isn’t.
MITCHELL KATZ, PH.D. is senior vice president, global clinical operations, at Kyowa Kirin.