Seeking New Treatments for the Sickest Patients
Palo Alto Medical Clinic Founder Russel Lee, M.D., started the Research Institute in 1950 as a place where doctors could test new patient care ideas that occurred to them during practice. While the Research Institute has since grown into a place with significant scientific capabilities of its own, a small group of staff members remains committed to carrying out Dr. Lee's original vision.
The Department of Clinical Research, managed by Barbara Anderson, R.N., works with PAMF doctors interested in conducting trials of new therapies, sometimes to treat patients with no place else to turn. Anderson and her staff help physicians receive the required safety approvals for their studies, recruit and monitor patients, coordinate with outside sponsors and ensure compliance with privacy regulations.
Studies are often driven by doctors who have discovered new ideas in practice and want to formally test them in order to publish and share the idea with fellow physicians worldwide. Other studies are initiated for compassionate reasons: to provide access to a medication or device that is not yet approved for widespread use but that the physician thinks has great benefit for a particular patient. These studies also can help speed approval of a drug or device, helping future patients.
Last year, for example, Anderson was able to step in and procure an unapproved chemotherapy drug for a PAMF patient with terminal leukemia. Clinical trials of the medication had finished and the Food and Drug Administration (FDA) was considering it for approval, but had not yet made it available. However, Medical Oncology nurse Barbara White, R.N., and Clinical Manager Lynne McCoy, R.N., felt strongly that the medication could help prolong the dying woman's life. They turned to Anderson for help negotiating the system.
Anderson scrambled to collect pages of documentation, including a personal appeal from PAMF oncologist David Leibowitz, M.D., requesting FDA permission for "special" use of the drug. Within two hours of filing her complicated petition, Anderson received government approval. She was able to obtain a similarly rapid response from the drug company to coordinate express shipping of the drug to PAMF. The medication allowed the patient to live through Thanksgiving, a personal goal.
Anderson and her staff have national certification in coordinating clinical research, which –- along with the excellent reputation of its physicians -– makes PAMF an attractive place for outside sponsors looking to start studies. Another draw is how willing PAMF patients are to participate. "Often, patients will not see a direct benefit from the study, but it does not matter to them. They have this altruistic view of things, this desire to improve care for others," Anderson said. "That commitment is remarkable in the research field, and it contributes greatly to our success."
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Barbara Anderson followed her mother into nursing and spent the first 15 years of her career providing bedside care at a hospital in Canada, where she grew up. In 1985, a hospital neurologist asked for her help on a study of patients with encephalitis, and the interesting experience shifted her focus toward research. After various jobs -- and a move to the Bay Area in 1993 -- she joined PAMF in 2001 as manager of the Department of Clinical Research. But her first calling has never really left her: Anderson says one of the most enjoyable aspects of her job is interacting with the patients who participate in clinical trials.