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In an effort that should let FDA experts spend more time analyzing data and less time reformatting it, the FDA on Wednesday announced a new standard that drug sponsors can use to submit data from clinical trials to the agency. The Food and Drug Administration is exploring making the standard a requirement for data submission.
The standard, called Study Data Tabulation Model (STDM), was developed by a nonprofit committee of research companies, the Clinical Data Interchange Standards Consortium. Clinical research organizations, drug sponsors and regulators all will find their data processing efforts “greatly expedited,” said David Handelsman, global strategist for clinical research and development at SAS Inc.
The North Carolina company helps drug sponsors analyze data from clinical trials and is a member of CDISC, along with dozens of other companies, including the largest pharmaceutical firms.
Handelsman said the biggest challenge to creating the standard was companies recognition that they should “differentiate themselves on their science, and not how they process data” and “putting aside their individual and established standards” to create a common one.
The FDAs acting commissioner applauded the standard and said it could boost efficiency. “The importance of a standard for the exchange of clinical trial data cannot be overstated,” acting commissioner Lester M. Crawford said in a statement.
“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 FDAs ability to evaluate the data and help speed new discoveries to the public,” Crawford said.
The CDISC standard for the exchange of clinical trial laboratory data is approved as a Health Level 7 Reference Information Model (RIM) Version 3 message, making it compatible with standards being developed in the health care community. It also can also be implemented through ASCII, SAS and XML options.