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. Karen Antman, Breast Cancer
Dr. Karen Antman faces some challenging issues as she conducts research on bone marrow transplantation to treat breast cancer.
tors that bone marrow transplants are efficacious. The intensive treatment involves high-dose chemotherapy followed by stem cell replacement. The patient's bone marrow is removed and stored before chemotherapy and replanted after chemotherapy ends. Despite the intensity of the marrow transplants, many patients facing a 60 percent to 75 percent chance of dying of breast cancer within five years with conventional chemotherapy
are willing to take the risk of bone marrow transplant based on existing data, and they are able to find doctors who will perform it.
What this means for Dr. Antman is that many patients are unwilling to enter a clinical trial where there is a 50 percent chance they will be randomized into
the standard chemotherapy arm. Because research has not determined definitively that a bone marrow transplant improves a woman's chances of survival, it is important that randomized clinical trials are completed, Dr. Antman says.
The challenges Dr. Antman faces are unusual in that most clinical trials test drugs or therapies not available outside of the clinical trial. This is particularly true for drugs, which cannot be used outside of a trial until they have received FDA approval. Patients who know they will receive an active experimental treatment often are willing to give it a try, but they are more reluctant to enter randomized studies knowing there's a 50 percent chance they will be given the standard therapy.