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STATE-OF-THE-ART PAPER

An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

Richard L. Popp, MDMACC^_*, Beverly H. Lorell, MDFACC, Gregg W. Stone, MDFACC, Warren Laskey, MDFACC, John J. Smith, MDJD^|| and Aaron V. Kaplan, MDFACC^¶,_*

^_* 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).

This paper is the result in part of sessions at the Second Dartmouth Device Development Symposium (3D2) held at the Woodstock Inn, Woodstock, Vermont, October 14 and 15, 2004.

Recent reports regarding the suppression of data from clinical trials that identified a relationship between serotonin-reuptake inhibitor antidepressants and suicide in children as well as the connection between cardiovascular events in patients taking cyclooxygenase-2 inhibitors has led to broad public debate regarding the importance of public registration of clinical trials. This has led to congressional hearings, editorials in leading medical journals, and position papers from leading medical societies. The focus of these discussions has been primarily on pharmaceuticals, with little attention on the role of public registration of clinical trials involving medical devices. 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 provides a background to these issues and recommends pathways to the implementation of a national device trials registry.

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