Abstracts

Rationale: To assist investigators in reducing study start-up time, introduce efficiencies across studies, and prepare for data sharing requirements for completed studies, NINDS, with KAI Research, Inc. (KAI), initiated a common data elements (CDEs) project. The project goals are to provide the research community with an innovative way to collect and share data that will meet NIH guidelines. The project involved development of two types of standardized data collection forms and related materials including definitions, data dictionary, and use instructions: ● “Core” forms for use across neurological studies such as an Adverse Events form ● Disease-specific forms for commonly studied neurological disorders, beginning with epilepsy, such as Disease History. Methods: To identify the epilepsy CDEs, the project team reviewed current literature from high-enrolling clinical trials for treatment of epilepsy. These publications were then reviewed by a research scientist, who identified epilepsy-specific data elements in each study. The identified elements were compiled in a matrix to highlight consistencies across studies as well as outliers. Concurrently, case report forms (CRFs) from both NINDS- and industry-sponsored epilepsy studies were reviewed. Data elements on the forms were assigned both a broad category and a specific epilepsy category. Broad categories are form-level topics, such as Medications, while the specific epilepsy categories are elements, such as Anti-Epileptic Drugs. Elements that were found in several studies or were otherwise determined to be clinically important were assembled into an Epilepsy Data Dictionary to describe the universe of potential data elements specific to epilepsy studies. To help conceptualize these elements in a clinical trial setting, the data elements were grouped on to Epilepsy CRFs. The end products are Epilepsy CRFs and an associated data dictionary for investigators to use as they develop clinical study grant applications for epilepsy. Results: The CDEs development team found that the literature search, while informative, does not yield consistent or clearly identifiable data elements for epilepsy. As epilepsy research evolves, new clinical research techniques are implemented through study protocols, as shown in the CRF review. Thus the CRF review, while more labor intensive, provides a clearer picture of the data elements relevant to current and future epilepsy research. Conclusions: The forms and data dictionaries created through the above process will be posted to the NINDS CDEs Web site at www.nindscommondataelements.org and members of the epilepsy community will be invited to form a Working Group (WG) to review, utilize, and comment on the proposed CDEs and suggested materials. Validating the elements in this manner is essential to ensure the project is providing a clinically relevant tool to aid in research, instead of an extraneous model that would be burdensome to investigators.