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STATE-OF-THE-ART PAPER

An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

Richard L. Popp, MD, MACC^_*,1, Beverly H. Lorell, MD, FACC^,2, Gregg W. Stone, MD, FACC^,3, Warren Laskey, MD, FACC^,4, John J. Smith, MD, JD^||,5 and Aaron V. Kaplan, MD, FACC^¶,6,_*

^_* Cardiovascular Medicine Section, Stanford University, Stanford, California
Guidant Corporation, Indianapolis, Indiana
The Cardiovascular Research Foundation and Columbia University, New York, New York
Cardiology Section, University of New Mexico, Albuquerque, New Mexico
^|| Hogan and Hartson, LLP, Washington, DC
^¶ Cardiology Section, Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Manuscript received April 15, 2005; revised manuscript received August 9, 2005, accepted September 8, 2005.

^_* Reprint requests and correspondence: Dr. Aaron V. Kaplan, Cardiology Section, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, New Hampshire 03756-0001. (Email: aaron.v.kaplan{at}hitchcock.org).

Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

Abbreviations and Acronyms   3D2 = Second Dartmouth Device Development Symposium   DD = device development

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