Department of Biostatistics Seminar Series

The Impact of the Early Days of AIDS Clinical Trials on Clinical Trials Methods and Practices: The Role of Statisticians

Susan S. Ellenberg, PhD

Professor of Biostatistics, University of Pennsylvania

The first randomized trial to show benefit of an antiviral drug was completed in 1986, and demonstrated the efficacy of AZT, which was then rapidly approved by the FDA. At that time, the National Institute of Allergy and Infectious Diseases established a new unit (initially the AIDS Program, later the Division of AIDS) to facilitate the conduct of HIV research. A Biostatistics Research Branch was established in that unit in 1988. Many challenging issues arose in the early days of AIDS treatment trials, and statisticians, both within and external to the NIAID, played a major role in addressing many of these challenges. These included the approach to interim monitoring, the validity of surrogate endpoints, the need for randomized designs and placebo controls, and, perhaps most visibly, the appropriate role for patient advocates in the clinical research process. Some of these issues have emerged more recently in the context of the Ebola epidemic of 2014-15; the early experiences with AIDS trials are worth revisiting in considering approaches to drug and vaccine development for new epidemics.

Topic revision: r1 - 06 May 2016, AshleeBartley
 

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