The Association of Clinical Research Organizations (ACRO) and the FDA have announced a new initiative to modernize the clinical trial process with the formation of a collaborative group to support the development of data collection standards for regulated biomedical/clinical research.
The collaborative is part of the FDA's Human Subject Protection/Biomedical Research (HSP/BiMo) effort, a component of the agency's Critical Path Initiative. The Clinical Data Interchange Standards Consortium (CDISC), dedicated to improving the efficiency of medical product development, will lead the effort and will encourage broad stakeholder involvement, including representatives of ACRO along with those from FDA, National Institutes of Health (NIH), including the National Center for Research Resources (NCRR) and the National Library of Medicine (NLM), American Medical Informatics Association (AMIA), C-Path Institute, Pharmaceutical Research and Manufacturers Association (PhRMA), and others.
"We must have high-quality data to support new product applications," said Dr. Janet Woodcock, deputy commissioner for operations at the FDA. "Data collection standards will be enormously helpful to regulatory review and decision-making, and I applaud the efforts of ACRO, CDISC and others to significantly move this project forward."
In 2005 ACRO, in consultation with the FDA, initiated a pilot project aimed at standardizing the collection of clinical trial data. ACRO produced template forms for the collection of adverse event (AE) and concomitant medication (CM) clinical trial data, and outlined principles for standardizing the myriad case report forms (CRFs) currently used.
"We are very pleased that CDISC, which has been leading the charge for data standards for the exchange and submission of electronic data, has agreed to take on an initiative that will provide value to all levels of the clinical trial enterprise," said Douglas Peddicord, Ph.D., ACRO's executive director. "We look forward to working on data collection standards as one way to make the clinical trial process more efficient."
The FDA, CDISC and ACRO will convene in December 2006 at a Drug Information Association (DIA) stakeholders conference entitled, "The Quest to Enable the Electronic Clinical Trial." The two-day meeting will be held in Baltimore, MD and will focus on ways to optimize the clinical trial process with news tools and technology.