A 3 day course focused on the fundamental principles of clinical trial design and the role, of the data safety monitoring board (DSMB) in neurological trials. The course will include a comprehensive review of trial methods designed to minimize variability and error, how to utilize novel analytic approaches such as adaptive design to facilitate and accelerate the development program, key regulatory issues critical to the implementation of neurological studies. The course will also provide an intensive examination of the organization and operation of a DSMB, particularly for trials that incorporate adaptive design. At the conclusion of the course a certificate of training will be provided.
The course is intended for individuals with an interest in Clinical Trial design, novel analytic approaches to drug development, and participation in or organization of a DSMB:
- Academic and practicing neurologists who participate in clinical trials and/or serve on DSMBs
- Physicians & scientists in industry that participate in drug development and are responsible for the organization of a DSMB, particularly in the context of studies that employ adaptive design
- Federal employees and Foundations charged with overseeing clinical trials and DSMBs
