pivotal in this regard. At the time, most activism was still being directed at the FDA and the regulatory process, but activists were also openly critical of the AIDS Clinical Trials Group, which they accused of having produced no tangible results despite an investment of hundreds of millions of dollars. In Montreal, ACT-UP New York circulated a highly specific critique of the group's programs and protocols and called for sweeping changes in trial design (ACT-UP, 1989).
Investigators and statisticians initially offered predictable defenses of the traditional clinical trials process, but shortly after the Montreal meeting, as attention was focused on the surprising adoption of the parallel track concept by Dr. Anthony Fauci, an equally surprising event occurred. Dr. Susan Ellenberg, chief of the Biostatistics Branch of National Institute of Allergy and Infectious Diseases (NIAID) told activists and others that she found real merit in proposals for alternative designs (Green et al., 1990). She organized an NIH-FDA conference on clinical trial design in November 1989 and subsequently formed a statistical working group within the AIDS Clinical Trials Group as a forum in which novel trial designs could be debated and developed by statisticians, clinical investigators, activists, and persons with AIDS. This working group, which continues to meet, provided the first inroad for activists into the mainstream process of the AIDS Clinical Trials Group.
In September 1989, NIAID had awarded a large contract for statistical support to the Statistical and Data Analysis Center at the Harvard School of Public Health. This group, which had been providing limited statistical consultation to NIAID during 1989, began to provide increasing expertise in the design and analysis of trials. Senior statisticians at the center brought their significant experience in clinical trials in cancer to AIDS and formed a community advisory board to keep local community groups aware of their activities and to explain statistical issues in trials (Valdiserri, Tama, and Ho, 1988).
Later, the NIAID Division of AIDS and the leadership of the AIDS Clinical Trials Group (at least as a group) also became more amenable to inclusion of activists after several came uninvited to a meeting of the group in November 1989. Whether this cooperation represented the activists' banging down the door or clinical researchers' opening it is unclear. (To date, few of the principal individuals involved have written about or publicly discussed their recollection of these events.) Several individual trial sites (called AIDS clinical trial units) formed local community advisory boards to provide two-way communication of issues and concerns. Increasing interaction occurred among members of the AIDS Division staff and activists. A series of discussions and planning meetings ensued, and by July of 1990 Dr. Anthony Fauci announced that activists would have representation on all committees and in all activities of the AIDS Clinical Trials