CDISC Announces Finalization of New Standards for Clinical Laboratory Data; LAB Model Production Version 1.0 Released.

Business Editors; High-Tech, Health & Medical Writers

AUSTIN, Texas--(BUSINESS WIRE)--Jan. 27, 2003

CDISC announces the publication of the CDISC Laboratory Data Interchange Standard Version 1.0 Final.

The development of this CDISC standard data model is an important step in proposing worldwide standards for the interchange of clinical trial laboratory data.

This new CDISC standard is a content model for laboratory data generated during the conduct of clinical trials for biopharmaceutical product development. The Model has been developed over the past two years by the CDISC Lab Team, which includes representatives from biopharmaceutical companies, central laboratories, contract research organizations (CROs) and technology application developers. Development included multiple iterations and extensive testing with representative laboratory data. The Model was then further revised to address comments provided by a 65-member Laboratory Review Committee of industry experts and a public review (60-day posting period).

The Model is now available to all interested parties on the CDISC Web site (http://www.cdisc.org/standards/index.html), along with supporting documentation to assist in understanding and implementation. Additional information on implementation experiences and tools for implementation will be posted on the CDISC Members Area of the Web site. The content model, as structured, will support multiple implementation approaches. Currently, information to support ASCII and SAS are posted. A draft XML schema will be posted in the first quarter of 2003. An HL7 (Health Level 7) representation is in progress.

Worldwide data standards have the potential to make a significant impact in streamlining clinical trials and improving data quality. Lack of data standards costs the industry hundreds of millions of dollars annually. In a Customer Requirements Survey, industry stakeholders identified clinical laboratory data as the highest priority for developing data standards, as laboratory data can account for 60-80% of all data generated during the conduct of clinical trials.

"The resulting model is a giant step forward in terms of providing a useful and practical set of clinical lab data interchange standards with clear advantages over prior options available to the pharmaceutical industry," said Susan Bassion, Ph.D., leader of the CDISC Lab team.

"The GSK CT4 (Clintrial 4) Database Standards team has made every effort to incorporate the CDISC Lab Model in our standard panel designs. We have strived to be as consistent as possible with the CDISC Lab Model and Submission Data Domain Models in content, data formats and naming conventions. We have designed GSK CT4 panels that are flexible and will potentially allow additional CDISC Lab Model content to be incorporated in the future," said Margaret Hung, Data Management Tech Support/BDS, GlaxoSmithKline.

Nadine Billand, Director of Data Management for Quintiles Laboratories Ltd., said: "It is exciting to be a part of the Clinical Data Interchange Standards Consortium (CDISC), developing data transfer standards that will accelerate pharmaceutical and biotechnology product development for years to come. Quintiles is pleased to be a part of the team at the beginning of such an important event in standardizing clinical data interchange. Quintiles' corporate values include teamwork and leadership, and you couldn't ask for a better example than CDISC."

"IBM applauds CDISC for releasing CDISC Laboratory Data Interchange Standard version 1.0. This release marks a significant milestone in enabling the interoperability of clinical lab data," said Mike Kerzee, Solution Architect, IBM Life Sciences. "The introduction of this new standard will play a significant role in the integration of electronic medical records and clinical development systems."

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in the pharmaceutical industry.

For more information about CDISC, visit the Web site at www.cdisc.org.