Early Phase Clinical Research Support

University Of Arizona, Tucson AZ

Investigators

Linked publications, trials & patents

Abstract

Project Summary / Abstract: Early Phase Clinical Research Support (EPCRS) The goal of the EPCRS Program is to provide critical support to the UACC Early Phase Program (EPP), in which Early Phase trials with the potential for high impact are developed and initiated to provide access to Early Phase research to patients and high-risk persons from the UACC catchment area. The EPP provides support for short-term Pilot (pre-Phase I) and Phase I clinical research studies originating from UACC investigators whose outcomes form the basis of an application for later phase studies through external competitive grants, national group, or industry-sponsored trial support. The Phase I Multi-Disciplinary Team (MDT) manages the overall portfolio of Early Phase research and constitutes the oversight committee that reviews Early Phase research concepts. High priority is given to innovative investigator-initiated trials that focus on initial Early Phase testing of a novel candidate agent, device, or biomarker for the detection, prevention, or treatment of cancer; priority is given to those trials for which the preclinical development of translational science was performed by UACC researchers. The Phase I MDT is comprised of physicians and scientists with expertise in cancer therapeutics and chemoprevention trial development and basic scientists who conduct translational laboratory-based research. Early Phase concepts are further triaged by the Clinical Research Oversight Council, which ultimately ranks trials for EPCRS funding support. The EPP trial development and clinical operations are comprised of a Protocol Writer, Contract Specialist, Regulatory Specialists, Clinical Research Specialists, Research Nurses, a Research Program Manager, a dedicated Early Phase Nurse Navigator, and a Pharmacokinetics Technician. The EPP has conducted a wide range of studies that have led to novel scientific discoveries and to the further development of these discoveries in the context of later phase trials supported by NIH grant mechanisms and industry sponsored trials. A large portfolio of novel Early Phase IITs is currently in development and supported by UACC funding. These trials will utilize a broad range of analytic methods, including genomics, proteomics, metabolomics, analytical chemistry, cancer imaging, and bioinformatics.