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. Stanley Fahn, Parkinson's Disease
Dr. Stanley Fahn reviews an MRI to determine if this patient meets the eligibility criteria to enter his trial on fetal cell implants for Parkinson's disease. .
A fetal cell implant clinical trial that might subject individuals to sham surgery-even having holes drilled in their skulls-is attractive to Parkinson's patients who have tried everything else
It might seem as though Dr. Stanley Fahn, the H. Houston Merritt Professor of Neurology and scientific director of the Parkinson's Disease Foundation, would have difficulty recruiting patients into his study of fetal cell implants as a treatment for Parkinson's disease, given the fact that the research protocol calls for half the patients to receive a sham surgical procedure.
However, because the prognosis for Parkinson's disease is so grim and partly because the exclusion criteria for the trial are so selective, patients are eager to enter the trial and are willing to take the chance of having sham surgery. Also, the trial is attractive because it offers patients in the control group the option of having the actual surgery at the conclusion of the one-year study period if the surgery proves effective. This practice of compassionate use often is available in placebo-controlled studies to allow patients in the control group to ultimately benefit from successful experimental therapy.
To be eligible for the trial, patients must have had Parkinson's disease for seven or more years that is intractable to all available therapy. The surgery, both sham and real, is performed under local anesthesia. The experimental surgery entails drilling a hole in the skull, but the sham procedure does not penetrate the brain. Dr. Fahn has enrolled 16 of the 40 patients he needs.
According to Dr. Fahn's senior staff associate in neurology, Linda Winfield, RN, MPH: "Patients who find out about the study and want to participate must be highly motivated. They are required to make videotapes of themselves at their best and worst motor function, keep a diary of symptoms, and provide an MRI. These are evaluated by the investigators to decide which patients are eligible."