Georgetown University, Washington, DC - January 16, 2002 - The CDDS Workshop "Confirmatory Evidence to Support a Single Clinical Trial (SCT) as a Basis for Drug Approval," came to a successful conclusion today. In closing comments, CDDS Director Carl Peck, MD, summed up the workshop as "an excellent start on achieving its objectives, having intensified a healthy dialogue among academia, industry and FDA, and defined issues needing more work". He indicated that the workshop report will document breakout group findings and will identify "good ideas" for advancing understanding and use of confirmatory evidence of effectiveness for streamlining the drug development process according to Section 115a of the FDA Modernization Act of 1997 (FDAMA).
Rep. Richard Burr (R-NC), vice-chair of the House Energy & Commerce Committee, was unable to join FDA officials and other drug development experts at the workshop as originally planned, due to his duties as a member of the House Select Committee on Intelligence and the Subcommittee on Terrorism and Homeland Security. However, wishing workshop participants fruitful deliberations, he conveyed Congressional views concerning FDAMA Section 115a via a written statement to Workshop participants. Affirming his continuing interest in FDAMA, he acknowledged FDA's pioneering of single-trial approvals, and Section 115a's encouragement of "more complete use of all relevant clinical trials to affirm new drug effectiveness", noting also the value of "publication of new criteria to assist companies in minimizing extraneous data and information collection and filing."
Yesterday morning, in the first plenary session of the workshop, presentations by international experts on drug development and regulation explained the history and legislative background of FDAMA, gave academic, regulatory, and industry views on the nature and sources of evidence of effectiveness, explained a survey of industry use and view of single clinical trial approvals, and reviewed safety requirements.
In the afternoon, experts participating in breakout groups discussions grappled with difficult issues concerning (a) the nature and sources of "evidence of effectiveness", (b) the requirements for confirmatory evidence to support a single clinical trial approval and vice versa, and (c) requirements for an adequate safety database, assuming effectiveness is independently affirmed. Presentations of the findings from breakout sessions were openly debated in a second plenary session this morning.
A brief report of the workshop deliberation and conclusions is being drafted, and is expected to be available for dissemination within six weeks. The detailed workshop report is projected for publication later in the year. In the meantime, Powerpoint slides of plenary session presentations, Mr. Burr's statement, and breakout session reports are available on this website. For additional information, contact Julie Nelson at 202-687-1618.
The mission of Georgetown's Center For Drug Development Science is to establish clinical drug development science as a rigorous academic discipline for advancing new scientific methodologies, to contribute to the education of scientists engaged in clinical evaluation of drugs, and to provide solutions to real-world drug development problems. For more information, visit http://cdds.georgetown.edu
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