Regulatory Focus™ > News Articles > FDA Looks to Evaluate Probable Replacement for Current Drug, Biologic Data Submission Standard

FDA Looks to Evaluate Probable Replacement for Current Drug, Biologic Data Submission Standard

Posted 26 November 2013 | By Alexander Gaffney, RAC

US regulators have announced the launch of a new pilot project that will see the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) move toward a new data submission format.


As FDA explained in a 26 November 2013 Federal Register posting, FDA currently supports an ASCII-based data submission format known as SAS Transport, or XPORT (v.5). The standard was first developed in the late 1980's, and was recommended by FDA for use in all submissions in 1999.

But as the standard has aged, regulators have questioned whether it remains fit for purpose, especially as the amount of data collected by clinical trials continues to increase dramatically.

"XPORT is now considered by many to be an outdated transport technology for transferring data across different hardware and operating systems," FDA wrote. The problem is that XPORT is not extensible, meaning it is unable to accommodate future growth in submissions trends. It is, in other words, a stagnant platform.

FDA has been dissatisfied with the standard for several years now. In August 2012 it announced that it would hold a meeting to assess its suitability and to consider other possible standards for adoption.

A New Standard

And according to the Federal Register notice, FDA has now selected its data standard of choice.

Under the pilot program, FDA would move toward a new standard developed by the Clinical Data Interchange Stand Consortium (CDISC) known as the Submission Data Standards (SDS) Extensible Markup Language (XML).

The extensible standard will allow for interoperability and the review, analysis and reporting of large amounts of data as efficiently as possible, regulators have said. But now they need to test the new standard's advantages over the XPORT standard.

To do so, FDA said it plans to conduct "several" pilot projects to evaluate the new data transport standards, starting with one involving sponsors of prior applications to CDE and CBER.

"As part of this pilot, FDA would like to have sponsors participate in the preparation and submission of previously submitted study datasets using the SDS XML transport format," FDA wrote. "Participation in this evaluation will be outside of the regulatory pathway and, as such, will not be used to make regulatory decisions."

"A successful pilot may allow CDER and CBER to routinely receive study data that employ CDISC SDS XML format as the transport format once an alternatives analysis is completed," it postulated. The pilot will also allow it to assess the "technical capability" of the CDISC format, including its ability to archive regulatory study data.

FDA said it hopes for between three and five participants in the pilot, but will accept no more than six. Participants would need to provide data in both the XPORT and SAS XML data formats.

The pilot is expected to last 12 months.

Federal Register Notice


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