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Introduction
Incorporated as a non-profit organization in 2000, the Clinical Data Interchange Standards Consortium’s (CDISC) mission statement follows:
“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. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.”
CDISC has developed several clinical data models for transmitting clinical data between two organizations. The current state of CDISC has four main working groups: the Operational Data Model (ODM), Submissions Data Standards (SDS), Laboratory Data Model (LAB), and Analysis Data Model (ADaM). The ODM group defines standards for transferring clinical trial data between two organizations, especially between a sponsor and a Clinical Research Organization (CRO) conducting a trial. The SDS group is working with the FDA to define standards for submitting clinical data to the U.S. Food and Drug Administration (FDA) for a product marketing application. The LAB group is addressing standardization of data transfers for laboratory data to a sponsor or other organization. Finally, is the ADaM group is defining standards for transmitting analysis data to a regulatory agency.
All models are being developed to work using eXtensible Markup Language (XML) as an expected long term file format also in heavy use by other standards organizations as well as by the World Wide Web Consortium (W3C).
History
CDISC was started as a ‘grass roots’ group in 1997, hosting its first meeting of 25 attendees in the fall of 1997. During 1998, the Drug Information Association (DIA) invited the CDISC group to form a Special Interest Area Community (SIAC). By this time two working groups had been formed for Nomenclature and for Modeling. By the beginning of 1999, the first CDISC model was presented as the Submissions Metadata Model (SMM).
Early in the next year, the two working groups re-formed into the ODM and the Submissions Data Model (SDM) working groups. These two groups form the main pipeline for clinical data with the former defining standards for transferring data within a clinical trial and the latter for transferring data to a regulatory agency, particularly the FDA. Also by early 2000, when CDISC was incorporated as a non-profit organization, an early official model (v0.8) of the ODM was presented. This year the first major ODM version was also released (v1.0).
In 2001, another year of advancements for CDISC, the first major release (v1.0) of the Submissions Data Standard (SDS) by the SDM group was announced, a minor version of the ODM was released (v1.1) and ADaM was started. Also this year saw a formal agreement with the international standards body Health Level 7 (HL7) completed as the Clinical Trials Special Interest Group (CT-SIG) launched.
A Japanese CDISC group was formed in 2002, as was an HL7 Technical Committee called the Regulated Clinical Research and Information Management Technical Committee (RCRIM TC). A second major release of the SDS came out (v2.0) and the first major release of standards for transferring laboratory data appeared (LAB v1.0).
More recently, in 2003, a third major release of the SDS was issued and entered pilot testing. Also, both the SDS and the LAB models passed their HL7 ballots. This paved the way for real acceptance of the CDISC work by the FDA and other regulatory agencies. Also introduced this year was a first pass at standardizing clinical trial protocols.
In June of 2004, the SDTM v. 1.0 and the SDS, v. 3.1 were published. These publications were followed by a guidance that was issued by the FDA in July of 2004, which referenced the SDTM data format.
Current
SDTM v.1.1 was published in April 2005 followed by the SDS v. 3.1.1 published in August 2005. In support of continued collaboration between CDISC and the agency, a draft memo of understanding was generated on September 19, 2005.
Future
CDISC standards offer the opportunity to improve the efficiency of evaluation of safety and efficacy data for investigational treatments. The standards facilitate communication between regulatory authority & applicant and facilitate development of an efficient review environment.
The evolution of such standards in the future may make it possible to submit data directly through the eIND process, including all preclinical and clinical studies. It may also facilitate the submission of interim data through IND annual reporting processes.
References
1) DIA Annual - CDISC Session; July, 2001
2) CDISC, HL7, XML Simplified Demystified; Sept. 30, 2003
3) CDISC Web Site
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