Clinical Research

University Of Arizona, Tucson AZ

Investigators

Linked publications, trials & patents

Abstract

The mission of the Clinical Research Shared Service (CRSS) is to integrate and facilitate the management. Coordination and conduct of clinical research at the Arizona Cancer Center (AZCC) and to ensure that the clinical trial processes meets local, state, and federal policies and regulations. The following objectives are designed to accomplish this mission: (1) Provide centralized administration and processing of clinical trial documentation via the AZCC Clinical Administration Trials Office; (2) Provide centralized Data Management and Research Nursing services with a focus on Therapeutic trials; (3) Provide pharmacy admixture and inventory maintenance for investigational agents used in peer-review clinical trials in the multidisciplinary clinics; (4) Aid in the development of novel formulations or combinations of agents for investigators performing pilot clinical trials; (5) Oversee and ensure quality control in the conduct of AZCC clinical trials; (6) Implement a web-based clinical trials management system (Oncore¿) to facilitate peer-reviewed clinical research initiatives and reporting. Dr. Livingston is the current Director. Ms Ma, the Associate Director of Clinical Trials, assists with day-to-day operations of the CRSS. All clinical research-related documents flow through the AZCC Clinical Trials Office (CTO) for review, processing for further distribution and submission, and/or maintenance in study-specific regulatory files. The CTO also coordinates and provides administrative support for the AZCC Scientific Review Committee (SRC, Protocol Review and Monitoring System). Clinical research activities are accomplished via disease-specific teams consisting of clinical investigators, research nurse, clinical research coordinators/data managers along with regulatory assistants (IRB Coordinators) and other administrative support. The AZCC Data Safety and Monitoring Board (DSMB), chaired by Dr. Dragovich, is responsible for quality assurance/quality control in AZCC clinical trials. AZCC has implemented Oncore¿ to manage daily clinical research operations. Usage of the CRSS is mainly by AZCC members (77%) and spans most departments and programs. 61% of AZCC member users are with peer reviewed funding. In the period of July 2007-June 2008, The total accrual of therapeutic trials in the four NCI-defined categories is 284.