# Clinical Protocol & Data Management (CPDM)

> **NIH NIH P30** · ALBERT EINSTEIN COLLEGE OF MEDICINE · 2021 · $175,117

## Abstract

PROJECT SUMMARY - CENTRALIZED PROTOCOL AND DATA MANAGEMENT
The Centralized Protocol and Data Management Unit (CPDMU) provides centralized infrastructure,
coordination, and support for cancer clinical trials at the Albert Einstein Cancer Center (AECC), a component
of the Montefiore Health System (MHS). CPDMU supports the Protocol Review and Monitoring System
(PRMS) and Data Safety Monitoring Committee (DSMC), and the scientific activities of the AECC Experimental
Therapeutics (ET) Program. The CPDMU, with an annual operating budget of $4.5 million, includes 35 FTEs
who support 80 faculty PIs. MHS has substantially increased 3 operational managers focused on
administration and data investment in CPDMU (from $266,220 in 2017 to $570,913 projected for 2018). The
Velos-based Clinical Trials/Research Management System (CTRMS) was launched in 2015. The CPDMU has
been restructured with faculty member management - J. Sparano, MD director, S. Goel, MD (co-director for
protocol development), T. Ow, MD (co-director for protocol support), and B. Halmos, MD (Co-director for
precision medicine and immunotherapy). During the last funding period (7/1/13-6/30/18), overall intervention
accruals increased by 22% and intervention national trial accrual increased 2.1-fold. Based on 2017, in tumor
registry data reflected in Data Table 3, 10.8% of patients were enrolled on intervention trials, and more than
80% of trial participants were Hispanic or African-American. During the last 3-years (7/1/15-6/30/18), there
were 442 new protocols activated, including 306 intervention (15% institutional) and 136 non-intervention (85%
institutional). The CPDMU also supports participation as a Minority Underserved NCORP, reflecting a major
commitment to the NCTN (23% of new therapeutic trials and 32% of therapeutic accruals last year). Major
new initiatives include NCI-funded trials in breast cancer screening (EA1151-TMIST), anal cancer
screening/treatment (ANCHOR), and tissue collection in minorities with cancer (DCP-002, P9846).

## Key facts

- **NIH application ID:** 10228652
- **Project number:** 5P30CA013330-49
- **Recipient organization:** ALBERT EINSTEIN COLLEGE OF MEDICINE
- **Principal Investigator:** Joseph A. Sparano
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $175,117
- **Award type:** 5
- **Project period:** 1997-06-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10228652

## Citation

> US National Institutes of Health, RePORTER application 10228652, Clinical Protocol & Data Management (CPDM) (5P30CA013330-49). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10228652. Licensed CC0.

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