AEGiS-GMHC: Policy: Monitoring the ACTG

Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.

Policy: Monitoring the ACTG

Gay Men's Health Crisis Treatment Issues, Vol. 5, No. 5 - June 20, 1991
David Barr

Most AIDS clinical research is conducted through the AIDS Clinical Trial Group (ACTG), a network of about 50 medical centers, where studies about potential treatments for HIV and its complications take place. The ACTG is supported by the National Institute of Allergy and Infectious Diseases (NIAID), which is an agency of the National Institutes of Health (NIH). Other research in the United States may be conducted by pharmaceutical companies, government agencies, private or community research organizations or by another NIAID program called Community Programs for Clinical Research on AIDS (CPCRA), which conducts studies on AIDS drugs at hospitals and clinics in communities where the impact of the AIDS epidemic is severe. This article will focus on ACTG sponsored research sites which have recently established Community Advisory Boards (CABs) to represent community points of view, review study protocols, and address enrollment problems.

BACKGROUND

The ACTG is divided up into committees that develop the blueprints for the trials (protocols), recruit patients, make sure that standard care is delivered, and collect data. The committees are further divided according to scientific areas, such as opportunistic infections, pediatrics, patient care, data management, immunology, neurology, oncology, pharmacology/ pharmacokinetics, primary infection, and virology. The stated goals of the ACTG are "to conduct clinical trials that will (1) provide timely information to guide physicians in the selection of appropriate therapies for their patients, and (2) lead to the approval of new drugs." The Executive Committee oversees the entire operation.

FORMALIZATION OF COMMUNITY INPUT

In November, 1990, after repeated demands by AIDS activists, NIAID agreed that it would be useful to include people with AIDS and their advocates in the development and implementation of clinical research programs. As a direct solution, the Community Constituency Group (CCG) was formed. The CCG is made up of 24 people from around the country for broad-based representation of patient advocates and HIV-infected persons from a spectrum of affected communities. Its purpose is to represent community interests within the ACTG. Each CCG member represents a community or communities affected by AIDS. Members are chosen by the CCG itself, taking into account an individual's expertise in treatment issues and the communities from which he or she comes. Every CCG member also sits on an ACTG committee. In this way, community interests are represented throughout the ACTG, including the Executive Committee, which now includes two CCG members.

Substantively, the CCG focuses on a variety of issues, including clinical trial design, equal access to clinical trials and dissemination of information regarding research developments. One of the first acts of the CCG was to propose the creation of Community Advisory Boards at each site where ACTG trials are conducted. The CCG believes that community input is necessary on both national and local levels. CABs will be particularly useful for overseeing the diversity of trial accrual, ensuring that the needs of patients are met, and for helping to educate communities about treatments and clinical research. The Executive Committee accepted the CCG's proposal and now requires that every ACTG site establish and maintain a CAB.

CABs IN NEW YORK

In New York, there has been considerable difficulty getting the CABs up and running. New York has over seven ACTG sites, more than any other city. Establishing boards at each site is time-consuming and requires enough people willing to put in the effort. Recently, a meeting of people involved in the ACTG, including researchers, physicians,ACTG staff and activists was convened. The formation of the CABs was discussed at length. It was decided, despite the difficulties, that each site needed its own board to deal with specific problems within the individual institution. However, it was also felt that a central board, made up of members from the individual boards would also be useful to address citywide problems, such as trial accrual. In order to get more people involved in the ACTG and the CABs, forums are being planned at various ACTG and other sites which will educate people about AIDS clinical trials and the CABs. Another work group is meeting to discuss CAB structure and membership.

For more information, or to register interest in joining a local CAB, please contact David Barr at (212) 337-3569. [Editor's note: This is the first in a series of policy articles which will appear in forthcoming Treatment Issues.]

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