Protocol Specific Research Support

概述

Overview Goal and Objectives The goal of this resource is to support an increasing number of high quality, innovative, investigator-initiated early-phase clinical trials by providing experienced research nursing and data management support exclusively for the management of these trials. The availability of this research support is essential for trials that have high levels of complexity, high demand for specimens, and/or increased need for patient surveillance and interactions. Patients entered onto these predominantly Phase I or Phase I/II trials will have increased need for specialized research nursing to insure that 1) all consent is particularly well informed; 2) all adverse events are detected; 3) all requisite samples are obtained at the appropriate time and with expeditious and careful processing; and 4) feedback to and from the patients is maintained at an optimal level. Investigators making use of this facility will have the availability of the Cancer Center Shared Resources for tissue and genetic analyses, enabling clinical investigators without their own laboratories to initiate investigator-initiated protocols that include correlative studies. Rationale Stanford's Developmental Therapeutics group and their activities within the Molecular Therapeutics Program have been expanding. The vision over the next five years is to make early-phase clinical/translational research built on Stanford science the highest priority of the Cancer Center. The Freidenrich Center for Translational Research, to be completed in 2012, will be dedicated to this mission and will provide integrated space for patient treatment, research nursing support, and data management in a single location. This physical proximity, together with Dr. Sikic's (Associate Director Clinical Research; 05: Therapeutics) leadership and recent, anticipated recruitments in the areas of translational medicine and Phase I/II trial capability, will provide an ideal environment for the expansion of the early phase cancer clinical trial program.