Clinical Trials Operations and Biostatistics Unit (CTOB)
Overview
This Unit serves as the operations focal point for collaborative clinical trials on mental disorders in adults and children. The Unit has responsibility for operations and oversight of both contract-supported and cooperative agreement-supported multisite clinical trial protocols, as well as operations focus on special clinical trial research projects that may be undertaken by the Institute. In addition, the Unit has general leadership responsibility for over-arching matters related to clinical trials operations, such as the coordination of the ancillary protocols across the large trials, development of long-term strategies for clinical trials research (such as clinical trials research networks), improvement of the quality of clinical trials by development and monitoring of operations guidelines, and implementing the NIMH policy for dissemination of public access datasets. Unit staff serves as primary liaison with the Data and Safety Monitoring Boards for all matters related to the operation and conduct of the clinical trials. The Unit provides consultation to Institute staff and grantee/contractor staff on biostatistical matters related to appropriateness of study design, determination of power and sample size, and approaches to statistical analysis of data from clinical trials supported by NIMH.
Contact
Joanne Severe, M.S.
Unit Chief
6001 Executive Boulevard, Room 7127, MSC 9649
301-443-2334, jsevere@mail.nih.gov
