FDA Officials Say Industry Slow to Adopt SDTM

The FDA is eager for industry to implement the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) so reviewers can gain experience with the standard, but industry has been slow to respond, FDA officials said at a recent public meeting at agency headquarters in Rockville, Md.

The FDA adopted SDTM to accelerate its review of clinical trial data and new drug applications. The agency said it expects the model to provide a consistent framework to enhance data integration and reduce barriers to sharing the latest clinical trial data.

Data standards improve efficiency of clinical research, facilitate trial design, improve communications between researchers and study sponsors, and enable integration with an electronic health record system, Randy Levin, director of Health and Regulatory Data Standards at the FDA, said at the meeting.

Pfizer is the only sponsor to make an SDTM submission so far, officials said. However, a consultant in the audience said her clients have also done so. Reviewers may not realize submissions are in SDTM format unless study sponsors tell them, officials responded.