# Early Phase Clinical Research Support

> **NIH NIH P30** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $20,634

## Abstract

EARLY-PHASE CLINICAL RESEARCH SUPPORT: PROJECT 
SUMMARY/ABSTRACT 
Conducted through the Virginia Commonwealth University Massey Cancer Center (MCC) Clinical Trials Office 
(CTO), the Early-Phase Clinical Research Support (EPCRS) program provides MCC investigators with a 
comprehensive, high-quality, integrated platform to facilitate and accelerate the evaluation and development of 
promising scientific discoveries from the MCC research programs into early-phase clinical trials. Highest 
priority is given to MCC investigator-initiated trials (IITs) that advance concepts arising from MCC research 
laboratories into novel proof-of-principle, feasibility, and phase I, single-agent and rationally designed 
combinations of targeted agents that address the molecular signatures of tumors arising in our patients. 
Cancer Center Support Grant (CCSG) early-phase funds are used to support the clinical research 
infrastructure required to promote productive collaborations between basic and translational scientists in the 
MCC research programs and their MCC clinical research colleagues to translate innovative new approaches to 
cancer treatment identified through laboratory research into pilot and phase I clinical trials. New concepts for 
these trials are solicited from research program members and are prioritized by a well-defined and transparent 
review process overseen by the associate director of clinical research and facilitated by a standing IIT Concept 
Review Committee composed of senior MCC clinical, translational, and basic scientists. During the current 
period of support, EPCRS funds have been used to facilitate the opening and conduct of 12 new MCC-led 
investigator-initiated treatment pilot and phase I trials in solid tumors, hematologic malignancies and radiation 
oncology. These trials, which required 7 INDs, accrued 168 patients (60%) of the total 281 early-phase 
accruals. Total early-phase clinical trial local accrual of 281 accounted for 33% of the total MCC treatment trial 
accrual of 855 patients. 
MCC IITs have resulted in the definition of maximum tolerated doses for drugs and drug combinations and 
have identified cancers particularly sensitive to novel therapies suitable for phase II trials. The prioritization 
process in place is used to pursue a pipeline of additional innovative pilot and phase I trials, of which 6 are 
currently poised for initiation, with another 7 under development. Support from EPCRS funds focuses on trials 
addressing the unmet needs of the patient population in the catchment area served by MCC and support the 
mission of the NIH/NCI by providing access to early-phase clinical trials to patients within the largely 
underserved and minority populations in the MCC catchment area.

## Key facts

- **NIH application ID:** 10174768
- **Project number:** 5P30CA016059-40
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** HARRY D BEAR
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $20,634
- **Award type:** 5
- **Project period:** 1995-12-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174768

## Citation

> US National Institutes of Health, RePORTER application 10174768, Early Phase Clinical Research Support (5P30CA016059-40). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10174768. Licensed CC0.

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