CORE--CLINICAL STUDIES

University Of Alabama At Birmingham, Birmingham AL

Investigators

Linked publications & trials

Abstract

The Clinical Studies Shared Facility is charged with the implementation and support of the clinical trial activity of the Cancer Center with a major emphasis on Cancer Center investigator-initiated research derived from the Experimental Therapeutics Program and other clinical programs of the Center. Its staff is responsible for administrative/regulatory compliance, treatment, data management, and quality control of studies conducted within the Cancer Center, as well as the maintenance of a system-wide patient accrual data base. The day-to-day responsibility of the Shared Facility is jointly managed by an experienced oncology certified research nurse and an administrator. In addition, the staff includes 9 research nurses, 8 data managers, 1 technical assistant, a research staff. The Shared Facility provides oversight for all patients enrolled onto clinical trials within the Cancer Center and specifically provides the nursing and administrative support for the implementation of all UAB Therapeutics Program. This support includes nursing/pharmacy input in the conduct of the study, patient recruitment and enrollment, treatment and data management, and regulatory compliance and quality control. Thus, in 1997/1998, the Shared Facility provided nursing and administrative support for 458 patients enrolled onto clinical trials, approximately 50% of which were entered onto 34 UAB investigator-initiated clinical trials of novel therapeutic agents and involved complex nursing, data management and correlative laboratory effort. The Shared Facility regularly interacts with the Biostatistical Shared Facility and the Clinical Trials Review Committee on a daily basis, and through its staff is responsible for each and every aspect of administrative, regulatory and patient care for protocol patients, including maintenance of a sophisticated database of all patients enrolled onto cancer clinical trials within the Center.