Single-Patient Clinical Trial Policy Under Development at FDA

The FDA is “rushing” to establish policies for clinical trials to test therapies tailored for a single patient, the agency’s drug chief said June 4.

The policies are still in the early stages of consideration within the Food and Drug Administration, Janet Woodcock, the director of the Center for Drug Evaluation and Research, clarified to Bloomberg Law following her comments at the Biotechnology Innovation Organization convention in Philadelphia.

Once issued, polices to help researchers conduct an “N of 1” trial, in which a single patient is the entire trial, could provide enormous benefit for the 25 million to 30 million ...