# Early Phase Clinical Research Support

> **NIH NIH P30** · UNIVERSITY OF COLORADO DENVER · 2021 · $128,514

## Abstract

EARLY PHASE CLINICAL RESEARCH SUPPORT (Core-030)
ABSTRACT
The Early Phase Clinical Research Support (EPCRS) component provides data management support to conduct
novel early-phase clinical trials designed from research findings of UCCC members. The overall objective of the
EPCRS is to promote innovative clinical trials in the UCCC catchment area (the State of Colorado), to facilitate
inter- and intra-programmatic translational collaboration within UCCC, and to support the development of novel
cutting-edge therapies and strategies to prevent and treat cancer. These clinical trials are hypothesis-driven,
high-priority, innovative, Pilot (feasibility) or Phase 0/I institutional trials focused on early phase testing of an
agent or device for the diagnosis, prevention, detection or treatment of cancer. Expected outcomes include
subsequent later stage clinical testing through the National Clinical Trials Network (NCTN), the Phase II
mechanism of the Experimental Therapeutics Clinical Trials Network (ET-CTN), or in conjunction with
independent peer-reviewed grant support or industry funding. Although EPCRS was not funded over the last
cycle due to disapproval of our PRMS, UCCC has continued to conduct early phase trials which adhere to the
NCI eligibility requirements of this mechanism and through our NCI UM1 Southwest Early Clinical Trials (SECT)
Consortium (UM1CA186688) with MD Anderson Cancer Center, as well as institutional and industry support,
funding has been available to translate bench observations made by our translational UCCC members, to the
bedside. Going forward a number of changes have been instituted to further ensure that only the highest quality
early clinical science is carried out at UCCC. These include an Investigator-Initiated Trial (IIT) structure, that
includes an IIT Incubator (IIT-I) meeting chaired by Eckhardt that brings together a multidisciplinary group of
investigators to discuss and promote hypothesis-driven early trials, as well as an IIT Review Committee (IIT-RC)
chaired by Flaig and Eckhardt that is charged with ensuring that all components of a concept such as the
scientific rationale, statistics, data management, budgeting and finance are assembled to enhance feasibility and
to enable prioritization for funding decisions. In addition to the requested CCSG funds, UCCC will provide
$250K/yr for early-phase clinical trials that will facilitate expansion of IITs and provide greater opportunity for the
translational science of UCCC programs to impact patients in our catchment area. Our future directions include:
1) Establishing processes that stimulate direct collaborations between the UCCC clinical disease groups and the
UCCC Research Programs; 2) Working with preclinical scientists in the UCCC to enable the development of
novel animal models that can be used provide the rationale for hypothesis-driven early clinical trials; 3) Evaluating
challenges regarding participation among racial/ethnic and socioeconomically unders...

## Key facts

- **NIH application ID:** 10133554
- **Project number:** 5P30CA046934-33
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Dan Theodorescu
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $128,514
- **Award type:** 5
- **Project period:** 1997-04-04 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10133554

## Citation

> US National Institutes of Health, RePORTER application 10133554, Early Phase Clinical Research Support (5P30CA046934-33). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10133554. Licensed CC0.

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