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P&S Journal

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.

Testing the use of bone marrow transplants to treat advanced breast cancer proves a challenge when some patients and physicians have already decided the treatment works. Potential subjects sometimes choose the risk inherent in the transplant over the risk of being randomized into the non-transplant control group in a clinical trial.
Dr. Karen Antman, professor of medicine and director of medical oncology, does not have women breaking down her door to enroll in a National Cancer Institute-sponsored multicenter trial to compare the effectiveness of bone marrow transplant over conventional chemotherapy for stage II breast cancer. The study was initiated to confirm or refute earlier smaller-scale studies, the results of which have convinced many patients and some doc-

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.

copyright ©, Columbia-Presbyterian Medical Center

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