Early Phase Clinical Research Support

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14.0 Abstract: Early Phase Clinical Research Support UMGCC investigator-initiated pilot (pre-Phase I) or Phase I trials that test clinical interventions with a candidate agent or device for the diagnosis, prevention, detection, or treatment of cancer frequently require funding to support research coordination, data management, and regulatory functions. Data from these trial protocols can be used to support later-phase activities with these interventions or as a basis for acquiring funding from other sources to continue the piloted activities. This critical early support provided by Early Phase Clinical Research Support (EPCRS) is necessary to move such trials forward, especially because per-patient costs are not reimbursed. EPCRS funds will be for UMGCC personnel, including research coordinators and data managers, to facilitate innovative clinical investigation efforts. Trials supported by EPCRS will be subject to additional criteria for consideration by the Clinical Research Committee either before their implementation and development or after needs emerge that are not addressed by other sponsoring agencies. The trials will be assigned a priority scale for funding based on how the protocol is significant and innovative in promoting the development of novel cancer diagnosis, treatment, imaging, or prevention strategies and based on evidence that the trial will enable correlative science as a result of EPCRS funding, with translational collaborators and assays in place. During the most recent 5-year funding period, 21 trials were developed by UMGCC investigators within the guidelines for funding through EPCRS. The narrative highlights five protocols recently launched or in development as examples of trials that will benefit from EPCRS in the future. These trials flow from investigator-initiated clinical research or are the logical consequence of an alliance between basic scientists at UMGCC and clinicians well suited to address a translational science goal and are either not incorporated into other grant-supported or Cooperative Group trials of NCI or other funding agencies or have only partial industry support.