P&S Journal: Fall 1995, Vol.15, No.3
Clinical Trials: Recruitment, Sometimes Easy Sometimes a Thankless Task. The Adventures of Six Clinicians Recruiting Patients for Trials By Lynne Christensen;
Dr. Jane Pitt, AIDS Treatment for Children and Pregnant Women.
Dr. Jane Pitt places importance on the way risk is explained to potential clinical trials participants.
An HIV-positive pregnant woman who declined to participate in a clinical trial during
a previous pregnancy benefited from the trial's results
Convincing patients to enter placebo-controlled trials often depends on the recruiter's ability to explain risk. Dr. Jane Pitt, associate professor of clinical pediatrics and a member of the CPMC Institutional Review Board, conducts trials on children and pregnant women with AIDS. She explains to patients that trials are conducted when it isn't known for sure whether the intervention will be effective. She explains that randomization into a treatment or a placebo group dilutes the risk. If the therapy is inferior to no treatment, there is a 50 percent chance of being protected by being in the placebo group, and if the therapy is found to be effective, there is a 50 percent chance of receiving its benefits.
Sometimes patients are convinced and sometimes they're not, and sometimes it takes a while. Dr. Pitt describes one patient who was approached to participate in a test to study the effectiveness of zidovudine in reducing the rate of transmission of HIV from HIV-positive pregnant women to their babies. After having the trial and all of its implications care-
fully explained to her, the woman declined to participate.
The results of the trial turned out to be dramatic; the rate of transmission was reduced from 25 percent to 8 percent for women taking zidovudine. When the woman returned to the hospital pregnant with another child, she was treated with zidovudine. Because she ultimately benefited from a trial she was unwilling to participate in, she might be more inclined to participate in future trials.
Dr. Pitt's experiences in recruiting patients illustrate the role a patient's level of education plays in obtaining informed consent. Many of the patients she enrolls in her studies of HIV-infected women and children are poorly educated and may be only marginally literate. She emphasizes the importance of explaining everything very carefully, not rushing anyone, and encouraging patients to talk with family and friends.