CDISC Unveils New Standards for Clinical Laboratory Data; Feedback Sought Over 60-Day Period

Business Wire, June 13, 2002

Business Editors & Health/Medical Writers

AUSTIN, Texas--(BW HealthWire)--June 13, 2002

The Clinical Data Interchange Standards Consortium ("CDISC") announces the availability of the CDISC Clinical Laboratory Data Model for the clinical trials industry.

The completion of this model is the first 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. Developed over the past 18 months by the CDISC LAB Team, the new model is now available for public review and comment on the CDISC Web site (http://www.cdisc.org/standards/index.html).

Worldwide data standards have the potential to make significantly positive impacts in streamlining clinical trials and improving data quality. Lack of data standards costs the industry hundreds of millions of dollars annually. Clinical laboratory data, in particular, was identified in a Customer Requirements Survey of stakeholders in the industry as being 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.

CDISC invites all those interested in laboratory data interchange to visit the CDISC Web site to learn more about the CDISC Laboratory Model. The model will be posted for a 60-day public comment period. Comments should be posted by 12 August, using the Discussion Forum on the CDISC Web site (http://www.cdisc.org/discussions/discussions.html). At the end of the 60 days, the Lab Team will review and consider comments received and make appropriate modifications to the model. At that time, a production version of the Laboratory Model will be posted on the Web site as CDISC Laboratory Model Version 1.0.

"The resulting model should be a giant step forward in terms of providing a useful and practical set of clinical lab data interchange standards with clear advantages over the prior options for this purpose for the pharmaceutical industry," said Susan Bassion, Ph.D., leader of the CDISC LAB team. "The CDISC LAB team has already executed substantial testing of this model, using different implementation methodologies, and they have also addressed the comments of a 65-member external Expert Review Committee."

"The GlaxoSmithKline Database Standards team is making efforts to incorporate the CDISC Lab Model in our standard panel designs wherever possible. We intend to build certain flexibility into our GSK database panel designs so that we can incorporate additional CDISC Lab Model content in the future," said Margaret Hung, Data Management Tech Support/BDS, GlaxoSmithKline. GSK performed the testing of the model with two central core labs. One sent lab data in SAS(R) datasets and the other sent data in ASCII bar-delimited format. Partial production data were used as test data. According to Hung, "The test data were compliant to the study specifications and guidelines. Both data files were loaded successfully into GSK's legacy GOLD(tm) system."

The CDISC Lab Team consists of a group of volunteers from pharmaceutical companies, central laboratories, contract research organizations (CROs) and technology application developers. "These individuals have been extraordinarily dedicated to the task of developing a common data interchange standard for lab data. They have brought to the task their diverse talents and experience, including laboratory medicine, information technology, information systems, data management, programming and biostatistics," said Dr. Bassion.

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.