Abstracts

In the past decade many new medications have become available for various neurological disorders including epilepsy. Clinical Trials, an essential component of drug development, helps to establish efficacy and safety. Thus, clinical research has grown significantly in parallel to new medication development in the health field. It is critically important for investigators to identify and recruit potential candidates for clinical trials in order to efficiently complete studies and to evaluate drug efficacy and safety in a timely fashion. In order to improve and understand effective recruitment strategy, we surveyed current clinical study participants at our epilepsy center. Thirty-three Epilepsy patients who all are currently participating in one out of 5 (phase II, III or IV clinical multi-centered) epilepsy studies at BNI were asked questions pertaining to reasons for participation and continuation of study as well as primary concerns for participation when they were asked to participate in the clinical study. Patients were asked to rate their answers on a 0-10 scale with 10 being the strongest influence and 0 the least influence. Questionnaires were administered to patients during their clinic visits or via email and were analyzed. Twenty-nine out of 33 patients (88%) answered investigator rapport (physician and coordinator) to be the number one reason why they chose to participate in a study (X= 9.7). Three patients answered that the most important influential rationale was financial reasons (reimbursement or no insurance), and the remaining one patient stated no other medical options were available. When patients were asked what biggest concerns they had prior to consent, nearly all patients (94%) expressed the fear for unknown potential side effects. Even though seizure improvement was reported by 40% of the participants, only 1% (3 out of 33) stated efficacy was their number one reason for continuing in a study, while 91% (30 out of 33) chose to continue participation based on investigators[apos] care. This study shows that establishing a good patient/doctor rapport is the most important factor to successfully recruit patients for clinical trials. Regardless of the type of clinical trials, good medical care from investigators was the most important determinant factor in those who complete trials.