The FDA advocates the development of a new method of clinical trials to accomodate genetic information.
Instead of embarking on traditional clinical trials, drugmakers and clinical investigators need to work in different ways to select patients for what will inevitably be smaller trials, she said.
“Ever smaller subsets of patients are being identified, and we’re really going to have to put our heads together and figure out how do you study these small subsets of diseases,” (Janet Woodcock, MD, head of the FDA’s Center for Drug Evaluation and Research) said in a 45-minute speech on the FDA’s efforts to advance the field. “What types of trials and development programs do you do? And when does a subset get so small that you’re not going to be able to do a randomized trial?”