Abstracts

Rationale: The importance of post-marketing drug surveillance is to monitor negative side effects and identify superior treatment options. Performing continuous comparative effectiveness trials will allow physicians to strive for highest quality of care by identifying the most effective, safest and cost-effective methods for treating seizures. Our goal is to establish and implement an internet-based post-marketing antiepileptic drug (AED) registry that will provide clinicians and researchers with the ability to answer important questions about drug efficacy, safety and concomitant drug interactions ultimately leading to improved health care of persons with epilepsy. This goal of this project is to design and initiate a multi-center, collaborative, post-marketing AED surveillance registry. The internet-based design of the PADS database registry will allow multiple clinics to collect standardized clinically relevant information about newly released AEDs across a large and diverse patient population. Methods: This internet-based registry was adapted from the design and concept of the paper-based system utilized in studies conducted by the Post-marketing Antiepileptic Drug/Device (PADS) group. A team of research coordinators, web application developers and epileptologists worked to develop an infrastructure that can support multi-center data collection and oversight, including the use of a centralized IRB, creation of a secure web application and formation of a data-coordinating center (DCC). Results: A web application (www.padsregistry.org) was developed and piloted using patient data from the Regional Epilepsy Center. The website is designed to keep patient data secure by assigning study personnel specific levels of access and password logins. In addition to capturing the occurrence of adverse events, the database contains efficacy and tolerability data from a diverse group of patients often under-represented in clinical trial samples. These patients include: people with rare disease states, racial minority groups, pregnant women, children and adolescents. Conclusions: The uniqueness of this registry lies in the potential to conduct high quality comparative effectiveness studies by collecting a large volume of data across multiple clinical sites. The registry will accelerate the advancement of research and treatment options for a large and diverse population of patients by quickly identifying efficacy, tolerability and adverse events of post-marketed AED s by identifying which subgroups of patients who could benefit from each therapy. The PADS registry intends to expand into clinic sites outside of the Regional Epilepsy Center and hopes to involve multiple investigators, including members of the original PADS group. Involving a collaborative group of investigators from multiple sites will provide a very large and diverse patient population, which will promote accurate evaluations of the use and effects of newly released AEDs within realistic clinical settings.