FDA Announces Intent to Require CDISC Standards

In July 2004, FDA Commissioner Lester M. Crawford, FDA Commissioner announced the desire of the FDA to receive data in a standard format, the CDISC SDTM. "The importance of a standard for the exchange of clinical trial data cannot be overstated," said Dr. Crawford, "FDA reviewers spend far too much valuable time simply reorganizing large amounts of data submitted in varying formats. Having the data presented in a standard structure will improve FDA's ability to evaluate the data and help speed new discoveries to the public.”

While this was a very welcome message and encouraged many companies to begin to become more interested in CDISC standards, it hardly produced a sudden groundswell in the adoption of CDISC data standards among sponsors. Some observed that this really wasn't yet an FDA requirement, just a non-binding desire. Others noticed conference presentations and ongoing research and development activities by FDA staff on alternative approaches to data standardization which left doubts among sponsors whether CDISC standards would ever truly be required. Many of these decided to postpone doing anything about standards until a clearer and more emphatic message from FDA appeared.

But the landscape shifted this week when the FDA published a new position s on Study Data Standards for Regulatory Submissions (See http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm368613.htm).

This statement, preceded by similar language supportive of data standards in PDUFA V, made it clear that FDA is firmly committed to CDISC data standards, which will be required "in the near future" and that it's now finally safe for sponsors to move full speed ahead.

While it's unfortunate that Dr. Crawford's 2004 statement is still all to true after nearly a decade, it now looks like the age of data standards is finally upon us. No more excuses.