Women in Clinical Trials
It's important for women to enroll in HIV clinical trials. And at a time when 31% of new U.S. HIV infections are in women, and women account for about 17% of AIDS cases overall, it's more important than ever. HIV-infected women must be represented in clinical research in order to insure the availability of accurate information regarding side effects and pharmacokinetics in women as the face of the epidemic changes.
Both the Adult AIDS Clinical Trials Group (ACTG) and Community Programs for Clinical Research on AIDS (CPCRA) have included women in their trials since their inception. The overall enrollment of women as of 1997 was 19 percent of the adults in the CPCRA and 15 percent of those in the ACTG. The pharmaceutical scorecard has not been as impressive. In an attempt to bolster access for women to pharmaceutical-sponsored trials, the FDA proposed a rule that would permit the agency to place a study on hold if it unnecessarily excluded women or any other group. This "clinical hold" rule has not been adopted, but merits attention, as it promotes equal access to investigational medications and recognizes that women have the right to make decisions regarding their individual health in the face of HIV infection.
So what can we do immediately to encourage women to enroll in clinical trials? At the 1999 Conference on Women and HIV/AIDS, several sessions and poster presentations focused on the under-representation of women and proposed ways to increase women's participation in both pharmaceutical- and government- sponsored trials. Drs. Howard Edelstein and Susan Jacobson of the Family Care Network, a San Francisco Bay area consortium of agencies providing HIV care, initiated a surveillance study to gather information regarding barriers to women's enrollment in clinical trials. The survey was based on the assumption that both structural and attitudinal barriers exist that prevent women from enrolling in clinical trials. In order to identify those barriers, 101 HIV-positive women not enrolled in clinical trials and 40 women enrolled in clinical trials were interviewed. The primary care providers of the unenrolled women were also interviewed.
Among the women not enrolled in clinical trials, reasons for not participating included lack of information about clinical trials, lack of interest in participating, and fear of side effects. Interestingly, childcare, transportation, and amount of time required for participation were not cited as reasons for not participating.
Among the women enrolled in clinical trials, the greatest facilitator to participation in a trial was the support and/or recommendation of the primary care provider. Women enrolled in trials also identified the support of the research staff as a major facilitator to participation. Difficulties in participating in a study, cited by fewer than a quarter of the women, included amount of time required to participate and lack of transportation.
From the provider's side, perceived barriers to participation included gender prejudice in the medical profession, lack of knowledge about available studies, and lack of coordinated care. Although 48% of providers surveyed considered their patient to be a good candidate for a clinical trial, only 14% had discussed the option of participation in a clinical trial with that patient. Considering the importance that participants placed on their provider's recommendation to participate in a clinical trial, providers must have a vested interest in increasing the enrollment of women and translate this interest into action by referring their female patients to clinical trials.
This article was provided by AIDS Community Research Initiative of America. It is a part of the publication CRIA Update. Visit ACRIA's website to find out more about their activities, publications and services.