Shared Facilities: Clinical Trials Office
The Clinical Trials Office (CTO) has played a very important role in the rapid growth of investigator-initiated research at the Brown Cancer Center. The activity and success of this shared facility also reflects the success and growth of the Cancer Center as a whole.
The role of the CTO has been expanded to provide oversight, quality control, accrual/registration and demographic data entry in the central office. CTO interaction with the pharmaceutical industry has been enhanced to develop increased collaboration.
The goals of the CTO are to facilitate innovative investigator-initiated clinical research and test therapeutic modalities developed by research programs of the Brown Cancer Center.
Specifically, the CTO aims to:
- provide central management for the implementation, coordination, and conduct of clinical trials developed by Brown Cancer Center faculty and by extramural collaborators;
- ensure quality assurance in the operation, including monitoring of toxicities, clinical care, data collection and adherence to protocol-described procedures and the Cancer Center Data Safety Monitoring Plan;
- provide a central database of protocol-specific data, currently active protocols for use by Cancer Center investigators, status reports of protocols, and demographics of available, screened and participating patients for all Cancer Center clinical trials;
- provide research pharmacy support for the acquisition, storage, dispensing and tracking of all investigational agents administered to protocol patients;
- provide procedures for the internal assessment, financial support and conduct of phase 1 clinical trials of lead compounds and biologics developed by Cancer Center scientists;
- foster the development of investigator-initiated clinical trials that examine new uses and mechanisms of action for FDA-approved biologics and targeted therapies; and
- increase opportunities for patient trial participation.
Qualifications of the Staff
The staff of the Clinical Trials Office currently includes: Jason Chesney, M.D., Ph.D., Medical Director; Kathleen K. Rodger, Associate Director, Research Nursing; Hana Gragg, Regulatory and Administrative Systems Manager; six R.N.s, six data managers and an administrative assistant.