The FDA and CDISC selected a member of the clinical trial vendor community to a new data standards committee. Anthony Costello is a co-founder of Nextrials, a California electronic data capture (EDC) company. It’s not clear whether other members of the CDASH committee are yet to be nominated, or are serving anonymously, or both.

For the next year Costello, currently SCDM’s vice chairman, will work with other industry representatives on CDISC’s Clinical Data Acquisition Standards Harmonization Initiative (CDASH), which aspires to establish data collection standards and implementation guidelines for clinical trials. The group will look at methodologies to improve and streamline data collection, handling, review and assessment for all participants in the clinical trial process, including patients, research sites, sponsors and regulatory reviewers.

“The current industry process for collecting patient data during clinical trials can benefit from standardization,” Costello said in a press release. “By developing and implementing new data collection standards, we can not only better ensure patient safety and data quality and integrity, but improve the way all stakeholders access and assess study data. SCDM has a history of supporting data standards for clinical trials, and fully endorses this next logical step for CDISC.”

The seed of CDASH, according to CDISC, germinated within ACRO (Association of Clinical Research Organizations) and was publicly unveiled by the FDA’s Janet Woodcock at the 2006 DIA annual meeting. CDASH will focus on FDA Critical Path Opportunity #45, and is currently supported by a collaborative group of fifteen major organizations: ACRO, ACRP, AMIA, Baylor College of Medicine, CDISC, Clinical Research Forum, FDA, NCI, NCRR, NIH, NLM, C-Path Institute, PhRMA, BIO and SCDM. 

The first CDASH collaborative group meeting was held on August 22, 2006, in Bethesda, MD. The first CDASH working group meeting was held on October 18, 2006, at the SAS Institute. Over 70 representatives from contract research organizations, academia, government and industry participated. 

The project is tasked to develop a set of content standards (element name, definition, and related metadata) for a core set of global data collection fields (also known as case report form [CRF] variables) that will support clinical research studies. The initial scope of the project will be the safety data domains (i.e. adverse events, prior and concomitant medication, demographics and subject characteristics, medical history, etc.).

According to CDISC, the agenda of CDASH is quite ambitious. Its goals include:

•Develop initial set of data collection standards (i.e. safety domains that cut across all therapeutic areas, beginning with approximately 12-14 domains (e.g. AE, CM, DM)

•Develop definitions and metadata for the data collection elements.

•Annotate the agreed variables.

•Post initial set for global, open public comment, address comments and develop second iteration based upon those comments.

•Develop Implementation Guide(s) which document how to implement the data collection standards.

•Link elements with appropriate terminology (code lists), as developed by the CDISC-NCI-HL7 Terminology Team, to support the data collection standards, and post in Enterprise Vocabulary System (EVS)/ca Data Standards Repository (caDSR).