Document 0655
 DOCN  M95A0655
 TI    Proving clinical benefit in small, rapid trials: statement to National
       Task Force on AIDS Drug Development. 
 DT    9510
 AU    James JS
 SO    AIDS Treat News. 1995 Mar 3;(no 218):4-6. Unique Identifier : AIDSLINE
       AIDS/95700353
 AB    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.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY  Antiviral
       Agents/PHARMACOLOGY/*THERAPEUTIC USE  Biological Markers  *Clinical
       Trials  *Drug Design  Human  NEWSLETTER ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).