Clinical Trials Support

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

The Clinical Trials Support Resource (CTSR) supports clinical trials through administrative support, information technology, and regulatory affairs. The CTSR complements the Protocol Review and Monitoring System (PRMS) and encourages the advancement of cancer research. CTSR is supported by 49 staff members under the direction of Dr. Maurie Markman, Vice President for Clinical Research. Administrative Support within the CTSR supplies infrastructure for the day-to-day operational management of the clinical research program. This includes central management and oversight functions for coordinating and reporting on clinical research protocols. Regulatory Affairs Support from the CTSR is dedicated to servicing the needs of the clinical investigators and adhering to the highest standards of clinical research compliance with local, state and federal regulations. CTSR provides centralized support for the submission, review, approval, activation, modification, continuing review and termination of protocols involving human subjects research. This includes the staffing of the Institutional Review Board (IRB) and the Data Monitoring Committee (DMC). The staff coordinates and maintains regulatory data for tracking the life cycle of the research protocols. These regulatory documents are part of the master protocol file in CTSR and are in both electronic and paper media. Information Technology Support within the CTSR comes from the Research Applications Information System (RAIS) staff who support the development and maintenance of centralized databases for research-related regulatory and clinical data. The Protocol Data Management System (PDMS) and the Clinical Oncology Research system (CORe), provide structure and tools to manage and share clinical research data. The Protocol Document On-Line (POOL) database supports and facilitates the complete life cycle of the protocol document, including the submission, review and approval processes performed by the Clinical Research Committee and Institutional Review Board (IRB) meetings. During the last fiscal year, the funds used to support the CTSR salaries were $475,485 (25%) from the Cancer Center Support Grant (CCSG), $172,163 (9%) from user fees and $1,295,771 (66%) from the Institution. In the next award cycle, the level of support from the CCSG, the user fees and the institution is projected to be closer to 22% and 12% and 66%, respectively. The CTSR supported 2739 protocols from 599 cancer center members, of whom 81% hold peer-reviewed funding. During the last several years, the number of new protocols managed by CTSR has remained constant. Protocols that do not meet the UTMDACC scientific standards are typically withdrawn from submission and review. While the volume of protocols has not increased, the oversight of clinical research has become increasingly complex and time-consuming due to evolving regulatory requirements and the current research climate.