# Core 1: Administration and Biostatistics

> **NIH NIH P01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2020 · $261,609

## Abstract

CORE 1 SUMMARY/ABSTRACT
Core 1, “Administration and Biostatistics,” provides the Administrative and Statistical support for the entire
PPG. The core supports a Scientific Advisory Board that monitors PPG progress on yearly basis. Dr. Steven
Burakoff and Dr. Miriam Merad, both faculty members of the Icahn School of Medicine at Mount Sinai, and Dr.
Thomas Braun, lead statistician of the PPG for the past two cycles, have become additional members of the
scientific advisory board. Dr. Burakoff, the director of the Tisch Cancer Institute and original PI of this PPG at
its inception thirty years ago, will serve as interim PPG director in the event that Dr. Ferrara should be unable
to continue in his role. Dr. Burakoff will chair the executive committee until it selects a permanent successor
with advice of the SAB, subject to approval by the NCI.
This core provides biostatistical support for all three projects. Dr. Umut Ozbek of the Icahn School of Medicine
at Mount Sinai has replaced Dr. Braun as lead statistician. We have made this change after careful
consideration of the many other changes in the PPG, most important of which is the recruitment to Mount Sinai
of Dr. John Levine, Project 3 Leader of Director of Core 3. The extensive collaborations over the past two
cycles with Dr. Braun, particularly as they relate to the sophisticated analyses required in the development of
algorithms needed to determine eligibility criteria for clinical trials, impressed upon the executive committee the
need for iterative, face-to-face meetings that include Drs. Levine and Ferrara as well as the lead statistician
who can devote sufficient time to this project. Because all three Core directors and two of three Project
Leaders are located at Mount Sinai, we have developed a new collaboration with Dr. Ozbek who will serve as a
lead statistician at Mount Sinai. Over the past year Ozbek has engaged admirably with the statistical issues
that are central to the PPG, and in addition to numerous meetings with Drs. Ferrara and Levine, she had
attended Dr. Ferrara's laboratory meetings and several journal clubs that have analyzed the BMT clinical trial
data. She also reviewed in depth the clinical trial proposed in Project 3 and now serves as the statistician of
record for that trial. In addition, she has used new approaches to the definition of thresholds to define risk
strata by biomarkers with unsupervised machine learning techniques. Using the same algorithm, these
techniques have led to better classification of patients with moderate risk and identified additional patients at
high risk who would be eligible for clinical trials. We have included these data as examples of the types of the
types of analyses that enhance the science within the PPG.
This core also provides communication among PPG personnel and coordinates their interactions to ensure
optimal integration of all Projects and Cores. We have made more explicit the mechanisms that coordinate the
communication among...

## Key facts

- **NIH application ID:** 10006005
- **Project number:** 5P01CA039542-32
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** JAMES L. M. FERRARA
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $261,609
- **Award type:** 5
- **Project period:** 1997-09-10 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006005

## Citation

> US National Institutes of Health, RePORTER application 10006005, Core 1: Administration and Biostatistics (5P01CA039542-32). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10006005. Licensed CC0.

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