New FDA Standard May Speed Drug Discovery
By presenting a common format for submitting data from clinical trials, the FDA aims to improve its ability to evaluate the data and reduce the time spent processing it.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.