conducting basic research in the disease; the ability to develop dedicated facilities that are highly efficient for the conduct of such research (clinical research centers); the availability of specialized laboratory testing and nursing personnel trained in the requirements of research; and the availability of people to constitute an institutional review board to provide approval and oversight of the study and ensure proper protection of subjects.
The first significant changes in the traditional approach to clinical trials resulted from the large expansion in clinical research funded through the National Cancer Institute. The increasing numbers of young oncologists trained in the cancer research centers saturated the positions available in cancer centers and resulted in significant numbers of fully trained clinical oncologists establishing practices in smaller cities and towns, distant from cancer research centers. In response to this development, NCI established the Community Clinical Oncology Program (CCOP), which enabled community-based oncologists to be tethered to cancer centers and to use state-of-the-art cancer drugs in research protocols that were fully integrated into center-based clinical trials. CCOP has been extremely successful, but critical to that success are the well-established links with cancer centers and the available pool of oncologists fully trained in clinical research methods.
AIDS has strained the traditional system for clinical trials in several ways. First, unlike the situation for other fatal diseases, in which primary care physicians did not feel competent to treat unusual and severe diseases (like cancer), many community physicians with practices comprising mostly gay men acquired extensive experience in the management of HIV disease. Those physicians were often unwilling to transfer even part of the primary care of their patients to clinical investigators. Patients, too, wanted to remain with their physicians, many of whom were more tolerant than the medical establishment of alternative therapies. In addition, many gay patients had a deep distrust of a medical system that they saw at best as unwelcoming and often openly condemning of their life-styles.
As previously noted, access to investigational therapy has increasingly been viewed as a right rather than a burden (Annas, 1988; Bayer, 1990). Even a large and multicentered system may be "unfair"—in not meeting the needs of infected persons if there are geographical and financial barriers to access. Thus, many AIDS patients and their advocates have argued that studies could be done more efficiently and equitably and with increased patient compliance if community physicians and their offices participated in the conduct of clinical trials (Merton, 1990). An early example of such a community network was the Community Consortium of Bay Area HIV Care Providers, headed by Donald Abrams, a San Francisco physician. This group performed a study of the efficacy of three different doses of aerosolized pentamidine in the prevention of PCP, a trial that ultimately provided the basis for the licensing of aerosolized pentamidine for this purpose by the FDA (Abrams, 1990).