This proposal describes how the clinical research program at SNI prepares the institute for participation in the NEXT consortium and proposes three specific aims.
These aims are: 1. Develop an outreach program to support clinical trial recruitment in the Pacific Northwest. Recruitment of patients is a challenging aspect of clinical trials. SNI specialists have developed extensive referral relationships throughout western Washington and the Pacific Northwest and have proven success in subject recruitment. We plan to expand patient access to NEXT trials in our geographic region through a targeted outreach program. 2. Mentor junior clinical investigators. Young investigators are crucial to the development of a robust clinical trials program. SNI has a substantial contingent of young neurologists and neurosurgeons who have recently completed their fellowships and are currently developing clinical trials. Mentoring of these investigators will be accomplished through a clinical research course covering clinical trial design, biostatistics, ethics, patient recruitmet and regulatory responsibilities, and through a formal investigator's meeting led by the SNI NEXT Project Director. 3. Optimize NEXT clinical research performance by developing and monitoring key quality, safety and financial metrics. While SNI has a successful track record of clinical trial operations, we believe that leading research sites must seek to improve the quality of clinical trials management and minimize the cost of trial execution. Therefore, we will develop a set of performance metrics that will drive increases in data quality, efficiency, patient safety and cost control.
This proposal seeks to establish SNI as a key participant in the NINDS NEXT clinical research consortium. Implementing the specific aims contained within this application is anticipated to increase the quality of clinical research data, improve patient safety and decrease the cost of conducting clinical research.