An Outline for Public Registration of Clinical Trials Evaluating Medical Devices

• Published in: Journal of the American College of Cardiology 2006-04, Vol.47 (8), p.1518-1521
• Main Authors: Popp, Richard L., Lorell, Beverly H., Stone, Gregg W., Laskey, Warren, Smith, John J., Kaplan, Aaron V.
• Format: Article
• Language: English
• Subjects: Anatomy & physiology; Cardiology; Clinical trials; Clinical Trials as Topic; Conferences; Congressional investigations; Corporate sponsorship; Disclosure; Drug therapy; Equipment and Supplies - standards; Feasibility studies; Humans; Medical equipment; Medical technology; Pharmaceutical industry; Product development; Registries; Regulatory approval
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2005.09.079

An Outline for Public Registration of Clinical Trials Evaluating Medical Devices Richard L. Popp, Beverly H. Lorell, Gregg W. Stone, Warren Laskey, John J. Smith, Aaron V. Kaplan Recent reports regarding suppression of data from clinical trials evaluating pharmaceuticals, e.g., serotonin-reuptake inhibitor antidepressants in children, has led to broad public debate regarding the importance of public registration of clinical trials. These discussions have focused primarily on pharmaceuticals, with little attention on the role of public registration of clinical trials involving medical devices. The Second Dartmouth Device Development Symposium brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the Dartmouth Symposium is offered to provide background to these issues and to recommend pathways to the implementation of a national device trials registry. 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.