Bypassing Barriers - Refractory Partial Epilepsy
Clinical Monitoring, Project Management, Data Management, Statistics, Medical Writing, Central Laboratories, and Safety Pharmacology.
This study called upon the strengths of Quintiles' recruiting skills, organizational skills, and flexibility in working with patients to exceed recruitment goals.
Recruitment for this study was difficult because of the long (12-week) screening period during which the patients must have had at least 12 partial seizures and no longer than a 3-week seizure-free interval. Patients were also required to keep a diary to record events, but they found the standard computerized formats and terms difficult to follow. Failure to accurately record the information resulted in a high screen failure rate.
Because of the complexity of the protocol and the necessity for dose monitoring, the sites had to have the supplies on hand to meet the many variations in patient needs.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.