Speedier Approvals Lure Submissions to FDA's Database

Only four study-data tabulation model (SDTM) submissions to FDA's Janus cross-trial database had been received as of December, but many hope the lure of swifter regulatory approvals, thanks to the project's use of Clinical Data Interchange Standards Consortium (CDISC) standards, will bring in 10 or more by June.

That was the situation three months ago, according to officials at an FDAnews information management summit, but experts at a Drug Information Association (DIA) webinar March 2 pointed to "exciting progress" on Janus, which is the foundation for an integrated FDA review environment offering:

Highly efficient reviews; Validated, reusable tools; Cross-study capabilities; and Accountability and audit trails.

A draft guidance providing more detail is slated to be released in the second quarter, said Wayne Kubick, technical director for CDISC and senior vice president at Lincoln Technologies.

Ambitious Goals

The FDA and its industry partnership have ambitious goals for Janus this year, Kubick said. These include unveiling a complete version 2 of the trial design model and posting new domain models for microbiology and imaging, as part of a broader CDISC effort with the FDA and Health Level 7 (HL7) to align data-storage standards, Kubick noted.

But for Janus to work, the agency will need to see a "critical mass" of submissions using SDTM standards, he said. CDISC standards will help speed regulatory approval and improve data exchange among partnering companies. CDISC data models aim to support the end-to-end data flow of clinical trials from the source, into an operational database, through analysis and to regulatory submission.

To get started with SDTM, agency officials encourage contacting the Center for Drug Evaluation and Research (CDER) and arranging a sample to prepare and submit. This will help identify any problems before official submission, said Gary Gensinger, director of regulatory review support staff in CDER's business process support office. "SDTM is new for everyone," he said. "Advance notice is critical to CDER's training efforts."

While most clinical trial sponsors continue to use paper data-collection methods, more sponsors are using technology in their studies and there has been a significant increase in the use of electronic patient-reported outcome (ePRO) technology and electronic case-report forms (CRFs), representing a gradual implementation by industry. -- Michael Causey