Magazine article Drug Topics

AIDS Community-Based Trial Network Showing Results

Magazine article Drug Topics

AIDS Community-Based Trial Network Showing Results

Article excerpt

"There was great skepticism," said Mathilde Krim. "When I first suggested in 1984 that people who were not part of the research establishment could set up a community-based system to conduct AIDS research, I was laughed out of the room. But now," Krim said in an interview, "I predict that this system will become a model to address the needs of other diseases."

Krim is a cofounder of the American Foundation for AIDS Research. In 1988, AmFAR established the Community-Based Clinical Trial Network, the purpose of which was twofold: to address the need for rapid clinical testing and ultimate FDA approval of experimental therapies for HIV disease and to expand access to experimental therapies for AIDS and AIDS-opportunistic infections. Since then, CBCTN research has been instrumental in the approval of three AIDS drugs: aerosolized pentamidine, erythropoietin, and, more recently, rifabutin. AmFAR now has 45 centers (43 in the U.S.) devoted solely to AIDS research.

Cross-purposes: The AIDS crisis, Krim said, highlighted the inherent conflict between the needs of scientists for data and the needs of patients for treatment. Some AIDS patients in drug trials at academic institutions, she said, have been known to have their medication chemically analyzed, then drop out of the trial if it proved to be a placebo, or to share active drugs with HIV-infected friends. Such rampant protocol violations hamper research at large institutions, she said, as does the low enrollment that ensues from distrust over perceived cross-purposes of patient and researcher.

Marvin Zelen, professor of statistical science at the Harvard School of Public Health, agreed. "With AIDS, you have a situation where the protocol may demand no prior treatment, no other disease, or a CD4 count under 200," he said. "But because the agent being tested may be the only therapy that will do any good, people lie to get into a trial--and their physicians help them to do it."

"In trials conducted through the smaller clinics and private CBCTN physicians," Krim said, "there is more of a trusting partnership between patient and physician. The result is that the patient is more likely to enroll, to stay enrolled until the end of the study... and the physician, one the patient has selected, is more focused on the patient's best interests." Patients trust that if they are receiving a placebo and the active drug shows promise, their physician will make sure they get access to it. …

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