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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. Ralph Sacco, Stroke

The enemy is time when a stroke patient has less than six hours to consent to a clinical drug trial.

When Dr. Ralph Sacco receives a "stroke page," it means a stroke patient, who might be a candidate for his clinical trial, has been admitted to the hospital.

Dr. Ralph Sacco, assistant professor of neurology and of public health, performs studies in stroke, for which there currently exists no effective early treatment. He is careful to point out to patients that even if they wind up in the placebo arm of the study, they will receive the same standard of care as the treatment group and may even benefit from the intensive monitoring and close neurological follow-up they receive as a participant in a clinical study.

In recruiting patients into acute stroke trials, Dr. Sacco has discovered that his greatest enemy is time. The experimental medication he is testing in one trial must be started within six hours of the onset of stroke symptoms. The drug, Lubeluzole, is a novel neuroprotective agent that has been shown to limit the size of stroke when given in this time frame and, in preliminary studies, to reduce mortality after stroke.

A system has been set up that alerts members of his research team when a stroke patient arrives in the emergency room: Researchers are paged and the patient is immediately taken for a CT scan, which is often necessary for entry into a trial. A recruiter then approaches the patient to discuss the study. If the patient consents, treatment begins immediately.

The time frame can be problematic because many patients do not recognize the symptoms of a stroke and, therefore, do not seek medical attention promptly. Part of recruiting for a stroke clinical trial involves educating the public and health care professionals about the symptoms and signs of stroke in hopes of decreasing the delay between onset of symptoms and arrival in the emergency room.

When patients do reach the emergency room in time, they often want to take time to talk with friends and family, to get more information, and to think about their options before agreeing to sign a consent form to participate in a trial. Unfortunately, there is very little time available for this trial "Working in a clinical trial requires an efficient team approach with the cooperation of emergency medical personnel, nurses, physicians, technicians, as well as the patients and their families," Dr. Sacco says.

He cannot enroll patients who are aphasic due to stroke. According to the CPMC Institutional Review Board and New York State law, next of kin cannot sign a consent form for a relative to be enrolled in an experimental drug trial. This is intended to protect patients, but in Dr. Sacco's trials it skews the study population, resulting in biased selection.

When patients resist participating in clinical trials because they feel like "guinea pigs," Dr. Sacco appeals to the individual's feelings of altruism by explaining that even if the patient doesn't directly benefit from the therapy being tested, other patients in the future may benefit.

Although Dr. Sacco faces challenges in recruiting stroke patients for acute stroke studies, he has found success in recruiting patients with stroke and healthy people for his epidemiological study on stroke risk-The Northern Manhattan Stroke Study. He and colleagues tested the use of random digit-dialing to select control subjects in northern Manhattan who are over age 40 and free of stroke. They found that willingness did not differ by gender, but that subjects under 65 with less than eight years of education were most likely to participate. Hispanics were also more willing to participate than blacks and whites.

copyright ©, Columbia-Presbyterian Medical Center

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