Early Phase Clinical Research Support

University Of California At Davis, Davis CA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT Early Phase Clinical Research Support (EPCRS) provides support for the development and conduct of short term pilot and early phase investigator-initiated clinical trials (IITs). This is a valuable component to the UCDCCC's clinical research portfolio because, historically, proof-of-principle studies are rarely funded through other mechanisms. The use of EPCRS funding directly reflects the UCDCCC's overall mission and foci, namely pushing the use of precision medicine, reducing mortality from advanced diseases, rapidly assessing what looks like the most promising approach, and giving clinical outlets to our translational scientists. In the past funding period, EPCRS was leveraged to provide protocol development and regulatory assistance to Cancer Center clinical investigators pursuing IITs. EPCRS funded the effort of a Protocol Development Officer who assisted PIs in the drafting and consistency checking of the clinical trial protocol and informed consent documents as well as managing regulatory issues such as FDA IND filings or cross-filings, dependent on the study. This also included support for clinical trial registration into the clinicaltrials.gov website, as well as assistance in coordinating IIT development with the financial sponsor (either a granting agency, the institution, or industry). The selection of trials supported by EPCRS was made by the Associate Director for Translational Research (Dr. Lara) and presented as an informational item to the SRC upon study review and approval within that committee. The EPCRS also provided support for Clinical Research Coordinators for IRB submission and for some of the studies, assistance with patient data management and data entry. The effort expended by the Protocol Development Officer and CRCs as part of the EPCRS was supplemented by institutional funds. Support for early phase ?home-grown? clinical research will be essential to achieving these goals. For the upcoming funding period, EPCRS funds will provide infrastructural support to a novel ?microtrial master protocol?. This strategy extends the successful leveraged approach employed in the past funding period to facilitate novel and innovative proof-of-concept microtrials. This approach is highly complementary to the current efforts to expand our ongoing citywide Phase I clinical trials program.