CDISC Standards at Core of FDA Cross-study Clinical Trial Repository Project

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Standards from the Clinical Data Interchange Standards Consortium (CDISC) were specified in a project recently awarded for development of a Clinical Trial Repository (CTR) for the U.S. Food and Drug Administration (FDA). The FDA is partnering with the National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT) to create this CTR to support automatic validation, loading and management of data from clinical trials to support comparative effectiveness research and regulatory review. A subcontract to design, develop and implement the CTR database structure and related infrastructure was awarded to Ekagra Software Technologies, who will work with FDA and NCI to fulfill the requirements of this project by 2013.

The FDA leadership is to be commended on their efforts to adopt standards that will improve their reviews of new applications for therapies and to develop a database to support regulatory science and cross-product analyses

Standards from the Clinical Data Interchange Standards Consortium (CDISC) were specified in a project recently awarded for development of a Clinical Trial Repository (CTR) for the U.S. Food and Drug Administration (FDA). The FDA is partnering with the National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT) to create this CTR to support automatic validation, loading and management of data from clinical trials to support comparative effectiveness research and regulatory review. A subcontract to design, develop and implement the CTR database structure and related infrastructure was awarded to Ekagra Software Technologies, who will work with FDA and NCI to fulfill the requirements of this project by 2013.

The FDA, which currently houses the largest known repository of high quality research study data on safety and efficacy of biologics, drugs and devices, has long awaited a database to support comparisons across similar products. However, this requires that data be provided in a standard format to enable rigorous analyses and comparisons. The Statement of Objectives in the solicitation for the CTR project specifies that the vendor will provide operational support for the processing of CDISC Study Data Tabulation Model (SDTM) data as well as for the incremental load and testing of legacy-converted datasets during the implementation effort. The SDTM standard was developed through a consensus-based process over the course of the last decade to support the electronic submission of clinical research data to FDA to facilitate their reviews of applications for the approval of new therapies.

In addition, the solicitation indicates that the new CTR will be compliant with appropriate standards, including the Biomedical Research Integrated Domain Group (BRIDG) Model. The BRIDG model was initiated by CDISC in 2004 and is now supported through a collaborative group that includes CDISC, Health Level Seven (HL7), NCI and FDA. It is a means of harmonizing across all of the CDISC standards that support biomedical research from protocol through analysis and reporting. The BRIDG model is now a CDISC standard, an HL7 standard and is entering its last ballot cycle to become an ISO/CEN standard through the Joint Initiative Council for global harmonization of standards.

“The FDA leadership is to be commended on their efforts to adopt standards that will improve their reviews of new applications for therapies and to develop a database to support regulatory science and cross-product analyses” stated Dr. Frank Rockhold, Chair of the CDISC Board of Directors     “They are clearly striving to improve their processes for the benefit of public health.”

The request for proposals for the CTR states “the availability of this repository for organizing, and extracting scientific data about regulated products in a common "language" or format to support regulatory decision making underpins the success of any broader initiatives to comparatively evaluate product performance. Such a data repository will be developed during this project”.

For more information, please see: https://www.fbo.gov/index?s=opportunity&mode=form&id=3f9ce599bf3d89c4bdd18651d9d68ebb&tab=core&_cview=1

ABOUT CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website. Additional information on CDISC can be found on the CDISC website at http://www.cdisc.org.

The CDISC Vision: Informing patient care and safety through higher quality medical research.

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Shirley Williams
CDISC
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