Second International Congress Drug Therapy in HIV Infection 18-22 November 1994 Glasgow, UK

EIGHT YEARS OF EXPERIENCE ON A DSMB FOR HIV/AIDS TRIALS

Thomas R. Fleming
Department of Biostatistics; SC-32, University of Washington, Seattle, WA 98195 U.S.A.

Int Cong Drug Therapy HIV 1994 Nov 18-22;2:Abstract No. 1.1
AIDS 1994, Vol. 8 (Suppl. 4);S1

In randomized HIV/AIDS trials designed to provide definitive assessments of the effects of therapeutic interventions, periodic interim analyses of accumulating data enable investigators to discontinue a treatment as soon as its efficacy or toxicity has been established to be unacceptable. This not only satisfies ethical requirements, but also allows more efficient use of limited research resources. However, if inappropriate procedures are used in this process of monitoring interim data, the integrity and credibility of the trial can be compromised.

We will review the structure of the DSMB for clinical trials conducted by the AIDS Clinical Trial Group (ACTG) and the Community Program for Clinical Research in AIDS (CPCRA) and will consider its role in enabling necessary interim monitoring while safeguarding the rights of participating patients and preserving trial's integrity and credibility.

Monitoring experiences from several trials will be provided to illustrate some important issues, including the nature of deliberations involved in formulating recommendations about trial continuation or termination, the unreliability of efficacy results obtained during early stages of trial monitoring, responding to early negative results, the need for long term follow-up, and the hazards of relying on surrogate or replacement endpoints for the clinical efficacy endpoints.

Presenting author: Thomas R. Fleming

1994-11-18
1.1

Originally published in AIDS Volume 8, Supplement 4 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

Copyright © 1994 - Lippincott Williams & Wilkins. All rights reserved. All abstracts from the 2nd International Congress Drug Therapy in HIV Infection, appearing on the AEGiS web site, are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, or otherwise published without the prior written permission of Lippincott Williams & Wilkins. You may not alter or remove any trademark, copyright or other notice. However, provided that you maintain all copyright and other notices contained therein, you may download material (one machine readable copy and one print copy per page) for your personal, non-commercial use only.

http://www.aidsonline.com http://www.ovid.com