FDA Critical Path Opportunities Initiated During 2006
In March 2006, FDA published the second of two reports on the Critical Path to medical product development, Critical Path Opportunities Report and List. The Opportunities Report and List presented 76 specific scientific opportunities that, if undertaken, would help modernize the Critical Path sciences. The opportunities were identified through extensive outreach with patient groups, the pharmaceutical industry, academia, other federal agencies, and other health related organizations
Excerpt of Report: Streamlining Clinical Trial Data Collection
Private efforts to streamline clinical trial data collection through voluntary standardization of case report forms (CRFs) have recently been formalized under the auspices of the Clinical Data Acquisition Standards Harmonization (CDASH) Initiative. Catalyzed by the Clinical Data Interchange Standards Consortium and the Association of Contract Research Organizations, dozens of product sponsors, investigators, data managers and other stakeholders are working together to agree on a core set of data collection fields to support clinical research studies (i.e., creation of consensus CRFs and implementation guides for four "safety data/domains": adverse events, prior medications, concomitant medications, demographics and subject characteristics). FDA is providing input on issues as requested (e.g., FDA requirements). The CDASH process is open to any participant and will include a public comment process.