Proving clinical benefit in small, rapid trials: statement to National Task Force on AIDS Drug Development. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

Proving clinical benefit in small, rapid trials: statement to National Task Force on AIDS Drug Development. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Treat News. 1995 Mar 3;(no 218):4-6. Unique Identifier : AIDSLINE AIDS/95700353
James JS

Abstract: John S. James of AIDS Treatment News presents his thoughts to the National Task Force on AIDS Drug Development on the clinical benefits of small, rapid trials. Two main points are made: the first involves resolving the conflict between surrogate markers versus clinical endpoints. Mr. James suggests that the provisional assumption should be made that the surrogate markers are working and the markers should be used in many small, rapid trials to optimize combinations of some of the treatments now available, see how low the markers can reach, and eventually see how long they can be kept down. It is believed that these treatments can be tested without having to wait for people to get sick in the control arm, and that the combination treatments should be strong enough to get people who are now sick, well. The second point involves bringing in treatments besides those in high-profile development. There are dozens of possible treatments where everything is known about the drug except its interactions with other drugs commonly used in HIV disease. Rapid screening trials can be used to test the efficacy of these drugs and these interactions.

Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Antiviral Agents/PHARMACOLOGY/*THERAPEUTIC USE Biological Markers *Clinical Trials *Drug Design Human NEWSLETTER ARTICLE
951030
M95A0920

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