# Early Phase Clinical Research Support

> **NIH NIH P30** · UNIVERSITY OF CALIFORNIA AT DAVIS · 2020 · $188,014

## 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.

## Key facts

- **NIH application ID:** 9993302
- **Project number:** 5P30CA093373-18
- **Recipient organization:** UNIVERSITY OF CALIFORNIA AT DAVIS
- **Principal Investigator:** PRIMO N. LARA
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $188,014
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9993302

## Citation

> US National Institutes of Health, RePORTER application 9993302, Early Phase Clinical Research Support (5P30CA093373-18). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9993302. Licensed CC0.

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