The Coalition For Accelerating Standards and Therapies (CFAST) was introduced at the CDISC International Interchange in Baltimore October 22-26. By congregating experts from each industry, data standards are expected to be maintained and developed. The coalition between the FDA, the Clinical Data Interchange Standards Consortium, and the Critical Path Institute is centering their focus on data standards regarding individual diseases and therapeutic areas.
Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research expressed the need for revised data standards. Woodcock shared, “we need to develop standardized definitions for individual diseases and the therapeutic approaches to treat them.” While there are specific elements to clinical trials that have become standardized such as age and gender, there are still “data elements to clinical trials which require continued development. Not only could building common data standards expedite the process of recording/analyzing data, but could conceivably speed up the delivery process of therapies to patients.
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