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FDA Announces Standard Format for Human Drug Clinical Trial Data

ROCKVILLE, MD -- July 21, 2004 -- The Food and Drug Administration (FDA) today announced a standard format, called the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium (CDISC), that sponsors of human drug clinical trials can use to submit data to the agency. It is expected that this step will lead to greater efficiencies in clinical research and FDA reviews of New Drug Applications (NDAs).

The announcement was made at the Secretarial Summit on Health Information in Washington, D.C. At the Summit, HHS Secretary Tommy G. Thompson brought together technology and health leaders and others to plan for nation-wide systems of health information technology, including clinical as well as research-oriented developments.

“The importance of a standard for the exchange of clinical trial data cannot be overstated,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “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.”

SDTM represents an important step by government, academia and industry in working together to accelerate research through the use of standards and health information technology. In addition, the adoption of the standard is consistent with the FDA’s Critical Path initiative because it will help automate the largely paper-based clinical trials research process and foster easier communication and collaboration among clinical researchers. By providing a consistent framework and format for clinical trial information, this standard is expected to enhance data integration opportunities and thereby help to reduce data management barriers for sharing the latest clinical trial data.

FDA’s Critical Path initiative is focused on identifying both the problems and potential solutions to the daunting task of ensuring that the unprecedented breakthroughs in medical science are demonstrated to be safe and effective for patients as quickly and inexpensively as possible. FDA launched the Critical Path initiative on March 16, 2004, with the release of a major report entitled "Innovation or Stagnation? -- Challenge and Opportunity on the Critical Path to New Medical Products."

The SDTM standard will be added to other specifications listed under the draft guidance “Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions” on the FDA Web site at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM085361. FDA is currently exploring regulatory approaches to require the use of the STDM standard for regulatory submissions.

CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. More information on CDISC and the Study Data Tabulation Model is available online at www.cdisc.org.

Source: The Food and Drug Administration

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