PROTOCOL-SPECIFIC RESEARCH SUPPORT

点击翻译按钮获取中文摘要

The Office of Clinical Research (OCR) trains, supervises, and manages research nurses and data coordinators assigned to clinical protocols. Because these research personnel are supported through chargebacks based on actual work, rather than reserved through funded effort on specific awards, the OCR can allocate (and re-allocate) research support personnel to reflect current research priorities, studies, and eligible patients. This approach allows the Cancer Center to address the needs of investigators for access to a common research support personnel available for assignment to high-priority studies, such as investigatorinitiated feasibility and Phase I protocols. The OCR maintains teams of research support personnel with focused experience in both Phase I trials and in specific diseases, so that the personnel assigned to a specific Phase I protocol can reflect whether enrollment on a given Phase I protocol is restricted to a given disease. Research coordinators involved in Protocol-Specific Research Support are assigned to designated priority studies by the OCR. Work addressed includes learning new protocols, assuring documentation of informed consent, reviewing and confirming compliance with eligibility criteria, registering patients, coordinating protocol-required tests and visits, collecting and managing data, entering data into a computerized database, providing interim data summaries for the principal investigator, submitting timely adverse event documents, and providing quarterly reports to the Safety and Data Monitoring Committee. PSRS resources are specifically targeted to high-priority Dartmouth investigator-initiated phase I and feasibility trials (including proof-of-principle for novel therapies). In the most recent award period, Phase I protocol accrual totaled 437 patients, an annual average of 84 enrollments per year. The majority of Phase I accrual (71 %) was on Dartmouth investigator-initiated studies, averaging 65 patients per year over the past five years.