June 2, 2020
The U.S. Food and Drug Administration (FDA) announced a Request for Information and Comment on Rare Disease Clinical Trial Networks. In particular, the FDA is requesting public input on practical steps and successful approaches relating to the start-up, implementation and sustainment of global clinical trials networks, including specific considerations for establishing such networks for a range of rare diseases. Comments will be accepted for 60 days following publication of the docket, FDA-2020-N-0837.
The request for comments is part of the FDA’s continued work toward building the Rare Disease Cures Accelerator, a cooperative scientific initiative for the development of common, standardized platforms that can improve the characterization of rare diseases, incorporate the patient’s perspective in clinical outcome assessment measures and build clinical trial readiness in the pre-market space.