To support the efficient review of medical products, the U.S. Food and Drug Administration (FDA) has begun to require electronic submissions of study data that conform to standards specified in the FDA Data Standards catalog. These data standards include the Study Data Tabulation Model (SDTM) for tabulated clinical data and the Analysis Data Model (ADaM) for the analysis of the clinical data. Integrating analysis data standards into drug submissions can improve transparency and increase review efficiency, thereby allowing innovative therapies to reach patients faster. However, there remain many challenges to successful implementation of these standards and realization of their potential to increase drug review efficiency and improve patient access to innovative therapies.
On June 12, 2019, under a cooperative agreement with the FDA and in partnership with the Critical Path Institute, the Robert J. Margolis, MD, Center for Health Policy at Duke University will convene a public workshop to consider key implementation challenges and potential opportunities to advance the development and application of analysis data standards. This public workshop is being organized to fulfill FDA’s commitment as part of the Prescription Drug User Fee Reauthorization Act for Fiscal Years 2018 through 2022 (PDUFA VI goals letter) to convene a public workshop to advance the development and application of analysis data standards. Feedback from this workshop will inform ongoing and future analysis data standards initiatives at FDA as well as strategic planning efforts to improve regulatory review of electronic submissions.