UWCCC uses the CCSG Protocol Specific Research (PSR) support for member's pilot clinical and/or translational research studies that would benefit from timely funding. CCSG PSR funding supports the translation of UWCCC research originating from novel laboratory or clinical observations into clinical testing. UWCCC Scientific Programs support the translation and facilitation of these research ideas into the clinic. In addition to benefiting UWCCC through investigator-initiated research efforts for the local community of cancer patients, this funding mechanism also benefits our Wisconsin Oncology Network (WON) by allowing more rapid dissemination of novel cancer therapies throughout the state of Wisconsin. UWCCC Scientific Programs conducting clinical research such as Experimental Therapeutics or Imaging and Radiation Sciences provide structure for clinical research. This has resulted in disease groups having research nurse and data management staff adequate for the conduct of ongoing trials. However the extent of resources available to each group does vary. Therefore, UWCCC provides additional support for short term, feasibility and Phase I clinical trials originating from scientific investigators within UWCCC. Through UWCCC Data and Safety Monitoring System, oversight, auditing and monitoring for all clinical trials is accomplished. In addition, the OnCore database supports these clinical trials assuring data are accurately, timely and completely captured in the database. Criteria for support of these clinical trials are as follows: ? Trial should be high priority, innovative, feasibility (pre Phase I, pilot) and Phase I institutional clinical interventions focusing on initial early phase testing of a candidate agent or device for diagnosis, prevention, detection, or treatment of cancer. Support is not meant for all early phase I trials, for later phase trials, or for studies that do not involve testing of an agent or device. ? Trials must be conceptualize/designed by UWCCC members. ? Trials must be of short duration (likely one year or less.) ? Trials receiving support from other peer reviewed research grants, cooperative agreements, and contracts are ineligible. Trials may receive partial support from industry assuming all other criteria are met. ? Trials must be approved by UWCCC's PRMS. ? Funding is restricted to research nurses and data managers directly involved trial conduct.
The PSR funds allocated each year are applied to investigator-initiated short term, feasibility and Phase I clinical trials to support the efforts of research nurses and data managers for these projects. The PSR mechanism provides critical support for the growing volume and diversity of scientifically novel investigator initiated clinical research at UWCCC.
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