Sponsors Increasing Use of SDTM Standards for Trial Data

Clinical trial sponsors that are considering submitting data to the FDA based on Study Data Tabulation Model (SDTM) standards should provide early samples of data to familiarize agency reviewers with the new electronic format, experts say.

Firms might even want to submit both electronic and paper for starters, suggested Julie Evans, director of Technical Services for the Clinical Data Interchange Standards Consortium (CDISC). And sponsors should definitely engage the FDA in a conversation before submitting the data, she added.

The FDA has received four SDTM submissions so far and is anticipating 10 or more in the next six months, Evans told an FDAnews Information Management Summit last month in Bethesda, Md. The agency will soon release guidance on submitting data using SDTM standards, she said.

“FDA reviewers are eager to work with data and standard tools but most reviewers don’t fully understand SDTM and have little time to learn,” Evans 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 to regulatory submission.

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 (eCRFs), representing a gradual implementation by the industry.

“We’ve expected accuracy of data with paper for years,” Lisa Olson, principal consultant with the Morrisville, N.C.-based SEC Associates, told attendees. “With electronic data, the capabilities may be different, but the expectation is the same.”

Security will be an increasing issue in this arena as different people from multiple parties share data or hire out services — including from laboratories and contract research organizations — increasing the odds for more things to go awry, she said. The FDA still expects the investigator to be responsible for study data, so clinical investigators will need to monitor the various contractors involved in the clinical study as well as keep tabs on the audit trails to see who did what, Olson said.

If the FDA starts questioning data, it could mean a delay in getting a product to market, she said. Worse, if the data trail can’t be followed, the study could be thrown out, Olson warned.

Meanwhile, sponsors must understand the FDA mindset, which requires objective evidence, said Gordon Richman, vice president of EduQuest. Good intentions don’t count at the FDA, Richman noted. “If it isn’t documented, it didn’t happen,” he said. The FDA’s inspectorate is young and not intimidated by computers and this is making the agency less forgiving in these areas, he said.

Data discrepancies inject a huge level of distrust in an inspection, Richman said, describing a discrepancy as “the screaming red flare sent out into the night sky.” Be realistic and accurate, he suggested. “There is an attitude that FDA is irrational. Don’t kid yourself — most inspectional observations focus on very basic regulations … if you do it right, compliance will follow.” — Tamra Sami