Standardizing key study data specific to therapeutic areas (TAs) will facilitate clinical research and the evaluation of medical products. In 2011, CDER identified a set of therapeutic areas that could benefit from further standardization, organizing them into three tiers of priority. Several factors were considered at the time: (1) areas of particular medical need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity. The number and ordering of these areas may change as stakeholder input and further analyses are considered.
The roadmap below displays the TAs in priority groupings and suggests a series of standardization projects over time to achieve significant results by December 2017. This roadmap assumes standardization projects for therapeutic areas are scoped narrowly enough to be accomplishable within a 12-month period, and that subsequent projects in those areas build on the results. Periodically, updates to the timeline will be provided as progress, opportunity and additional information is available. The tabular version, also listed below, provides the current status information for all identified TAs.
FDA, CDISC, and the Critical Path Institute are collaborating on efforts to support development of therapeutic area standards. FDA is also collaborating with HL7’s Clinical Interoperability Council and other consortia to define related clinical concepts. We encourage stakeholders to engage in and, where possible, support these data standardization efforts.
Questions and comments can be forwarded to CDERDataStandards@fda.hhs.gov.
- PDUFA V Therapeutic Area Standards Initiative Summary Report (PDF - 143 KB) NEW
- Roadmap for Development of Priority Therapeutic Area Standards (PDF - 106 KB) (updated 3/20/2018)
- Table of Priority Therapeutic Area Standards(PDF - 304 KB) (updated 3/19/2018)
Therapeutic Area Project Plan(PDF - 296 KB)
FDA announces the availability of the Project Plan for Developing Data Standards for Therapeutic Areas. Under Section XII of the PDUFA V performance goals, FDA agreed to create a plan for developing distinct data standards for therapeutic areas using a public process that allows for stakeholder input through open standards development organizations. These data standards should enable and enhance the ability to integrate, analyze, and report regulatory information about therapeutic areas.