Office of Clinical Trials Operations and Management (OCTOM)
OBJECTIVE
The purpose of this new contract requirement is to provide comprehensive clinical research and clinical trials operations and management support for NIDCR-sponsored clinical research and clinical trials.
BACKGROUND
As part of its overall research mission, the National Institute of Dental and Craniofacial Research (NIDCR) supports clinical research on the cause, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. These studies, conducted extramurally through the funding of research grants as well as within the intramural research program, include Phase I-III clinical trials as well as population-based and epidemiologic and natural history studies.
NIDCR’s extramural program has an extensive clinical research portfolio that covers a broad range of clinical efforts. Studies span small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical trials conducted both domestically and internationally. They include preventive and therapeutic interventional clinical trials as well as observational clinical studies. Intramural studies are generally performed in NIH’s Clinical Center and include both outpatient and inpatient studies, although some studies are also international in scope.
Given the growing complexity and size of NIDCR’s clinical research program including the extramural program’s emphasis on large, Phase III studies, and a new focus on product development, along with the clinical studies in intramural, there is a need for a more centralized, standardized and cost-effective approach for NIDCR clinical research oversight and management.
This new contract requirement will provide operations and management support for the NIDCR clinical research program and will allow NIDCR to consolidate much of the clinical research operations and management efforts and establish a more efficient and consistent approach to clinical trial and data management. In addition, the contract will provide valuable tools, systems and services necessary for NIDCR staff to effectively manage its clinical portfolio. Activities supported by this contract may include: 1) consulting/collaborating on study design and protocol development; 2) study document preparation, including designing of case report forms, procedure manuals and other study materials; 3) study-specific training and/or trial initiation site visits; 4) clinical trials operations support (e.g. drug packaging, labeling and shipping; clinical specimen storage); 5) data management; 6) assessing/assuring quality of study data; 7) study monitoring/auditing; 8) statistical data analysis; 9) safety monitoring; 10) regulatory support and FDA interface coordination; 11) preclinical product testing; 12) logistical support for Data Safety and Monitoring Boards; and 13) assistance with reporting and publication.