Fighting the Virus With Numbers
Sometimes in matters of life and death, numbers matter. Consider the example of AIDS Clinical Trials Group (ACTG) protocol 076, which set out to determine the efficacy of zidovudine in reducing the risk of perinatal HIV transmission. Harvard biostatisticians conducted an interim analysis of the data which showed a two-thirds reduction in the rate of transmission. As a result, the trial was immediately halted, and study investigators began offering the drug to all pregnant women and infants in the study.
With such advances in HIV research underscoring the increased need for biostatistical analysis, the Harvard School of Public Health recently announced the formation of the Center for Biostatistics in AIDS Research (CBAR). This center will allow Harvard biostatisticians to extend their leadership in the evaluation of HIV clinical research. Its projects will include the continuation of the biostatistical components of the adult and pediatric ACTGs, which conduct federal AIDS drug trials. CBAR will also serve as a nucleus for obtaining new public and private HIV-related biostatistical contracts.
"CBAR will provide a base of knowledge upon which clinicians can develop treatment plans for individual AIDS patients and policy makers can design national strategies for treating people with HIV," says Kenneth Stanley, CBAR's executive director.
The center will build on a strong foundation: in addition to ACTG 076, its staff has been associated with several other major advances, including assessments of antiviral therapies for HIV infection, analyses of treatments for common opportunistic infections, evaluations of surrogate markers that could speed clinical research, and innovations in the design and conduct of clinical AIDS trials.
CBAR will bring together a staff of nearly 60 biostatisticians, most of whom currently work for the Statistical and Data Analysis Center (SDAC), the Harvard group that provides biostatistical and data management support for the adult and pediatric ACTGs. This project--whose mammoth scope includes more than 100 participating hospitals, 30,000 adult patients, 5,000 pediatric patients, and 300 clinical trials nationwide--will continue as before, except that SDAC will be incorporated into CBAR.
Specifically, CBAR's goals are: (1) to foster and conduct statistical scientific activity in clinical trials and other areas of HIV-related public health research; (2) to promote innovative strategies for medical interventions and study designs for new HIV research; and (3) to provide education and training relevant to statistical aspects of HIV research. The center will be managed by a steering committee whose membership includes: Kenneth Stanley; Stephen Lagakos, scientific director; and Matthew Alper, director of administration.
- By Christen Kaczorowski
  
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