An outline for public registration of clinical trials evaluating medical devices

被引:3
|
作者
Popp, RL
Lorell, BH
Stone, GW
Laskey, W
Smith, JJ
Kaplan, AV
机构
[1] Dartmouth Coll, Hitchcock Med Ctr, Cardiol Sect, Lebanon, NH 03756 USA
[2] Dartmouth Coll Sch Med, Cardiol Sect, Lebanon, NH USA
[3] Hogan & Hartson LLP, Washington, DC USA
[4] Univ New Mexico, Cardiol Sect, Albuquerque, NM 87131 USA
[5] Columbia Univ, Cardiovasc Res Fdn, New York, NY USA
[6] Guidant Corp, Indianapolis, IN USA
[7] Stanford Univ, Cardiovasc Med Sect, Stanford, CA 94305 USA
关键词
D O I
10.1016/j.jacc.2005.09.079
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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收藏
页码:1518 / 1521
页数:4
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