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The crux of clinical trials.(LETTERS)(Letter to the editor)

OB GYN News

| March 15, 2006 | Utter, Garth H. | COPYRIGHT 2006 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Dr. David Orentlicher and Dr. Thomas Kintanar tackled a provocative topic, but missed some important points ("Should patients be required to take part in comparative clinical trials?" Pro & Con, Nov. 15, 2005, p. 5).

Refusal by eligible subjects to participate is only one impediment to completing useful trials, and certainly not always the major one. Arguably, the conduct of important trials is more commonly limited by insufficient government and industry funding; scarcity of appropriately trained clinical scientists, biostatisticians, and support personnel; and disinterest or prejudice of physicians themselves. Dr. Kintanar correctly emphasized that the best way to correct poor participation rates is to optimize communication during the consent process.

Requiring participation is justified as a means to evaluate potentially life-saving but time-sensitive therapies for emergency conditions when no other comparable therapeutic options are available and consent is impossible. However, the FDA ...

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