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# FDA Solicits Rare Disease Trial Network Info
- URL: https://www.fdaweb.com/fda-solicits-rare-disease-trial-network-info/
- Published: 2020-05-29T12:00:00.000Z
- Updated: 2026-09-14T16:16:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146889

FDA says it has established a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public on steps and successful approaches to establishng a rare disease clinical trial network. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-11655.pdf?ref=fdaweb.com) says comments will be received for 60 days.

The notice says that rare disease drug development “continues to be challenged by the small numbers of patients and limited understanding of the variability and progression of each disease.” FDA, it says, has proposed establishing a Rare Disease Cures Accelerator to provide a more centralized infrastructure and common platform and approaches to support **(1)** rare disease characterization; **(2)** development of standard core sets of clinical outcome assessments and endpoints relevant to rare conditions, and **(3)** conduct of clinical trials in rare disease populations.

The request for information will help the agency understand what work is currently being done and what work needs to be done to address the issue of improving the design, conduct, and completion of rare disease clinical trials, the notice says.