FDA wants a new study data exchange standard that would allow multiple systems to review and analyze the information without a lot of effort.

The agency’s existing system, known as XPORT, allows data exchange using a specific file format, but FDA wants to allow the exchange between systems where it “can be reviewed, analyzed, and reported with minimal need for data integration,” according to a Federal Register notice published Aug. 14.

A public meeting is scheduled for Nov. 5 at FDA’s White Oak headquarters to talk about new standards for the exchange of study data. The agency also wants written answers from industry, vendors and the public to 10 questions, ranging from industry data management challenges to opinions on specific standards models.

Comments, along with a cost-benefit study of moving to a new data standard, will help the agency develop an action plan and decide next steps, according to the notice.

The meeting appears to follow with goals included in the reauthorization of the Prescription Drug User Fee Act, which goes into effect Oct. 1. FDA is required to write draft standards for electronic application submission by the end of this year Also see "PDUFA V Implementation: A Year-By-Year Breakdown" - Pink Sheet, 5 September, 2011..

The agency has said it wants to increase the number of fully electronic submissions and also ensure all the data in its library can be easily used for regulatory inquiries.

Potential Candidates For New Format

The agency may have at least two potential study data exchange standards systems in mind, based on the questions it posed to the public.

FDA asked whether any open data exchange standards should be evaluated, but requested comments on whether the Health Level Seven International version 3 standards, including its message, structured documents and clinical data architecture, would be a viable alternative to its existing system.

The agency asked for the same assessment of the Operational Data Model from the Clinical Data Interchange Standards Consortium (CDISC).

FDA also wants to know the potential financial and technical impacts of both alternatives and how either could change business processes, according to the notice.

A decision between the two could hinge on how extensive a system industry and FDA want or need.

Edward Tripp, a member of the Health Level Seven International board of directors, said in an interview that the two standards handle data differently. He said the answer could be a combination of both, which may be why public input is necessary.

CDISC Chief Technology Officer Wayne Kubick said in a statement that the group is pleased the meeting was scheduled and that it should highlight the advantages of the Operational Data Model, which is a component of FDA’s study data standards.

CDISC already is helping FDA design its Clinical Trial Repository, a database that will automatically validate, load and manage clinical trial data so it can be used in research across products.

The database was expected to be ready in 2013 Also see "E-Submission Part Of FDA Reg Reform Plan; Alzheimer’s Data Standard About To Debut" - Pink Sheet, 29 August, 2011..

Industry also can comment on problems with designing data collections systems “so that relationships between data elements, as well as relationships across data domains, can be captured at the point of data entry,” according to the notice.

How Can FDA Make Data Capture, Integration Better?

FDA asked industry to list its “most pressing challenges” with study design, capture, integration, analysis, reporting and regulatory submission, as well as give potential solutions.

The agency also wants to know what it and industry can do to make the process more efficient and effective, including whether guidances would be helpful, and what would constitute a reasonable phased implementation period, according to the notice.

Comments on the pre-meeting questions are due Oct. 5.

FDA’s Data Format Standards Approaching Cost-Benefit Analysis Stage

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