# Core 3: Communications, Administrations, Advocacy, and Project Management

> **NIH NIH P01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $266,572

## Abstract

The Program Project encompasses four integrated projects to develop and maintain the infrastructure for developing and
implementing improvements in the I-SPY2.2 trial that employs early escalation/de-escalation of treatment and identifies
treatment strategies to optimize patient outcomes within a regulatory evidence generation framework. The primary aims
of the Communications, Administration, Advocacy, and Project management (CAAP) Core are to ensure program
integration, collaboration, patient acceptance, and regulatory compliance by providing project management, leadership,
and administrative support to all Projects and Cores; as well as the integration of advocacy in all patient-facing aspects of
the Projects and Core in the Program Project.
Perhaps the most critical role of the CAAP core is to coordinate the activities and deliverables of the projects and cores
with the study sponsor QLHC, its clinical operations team and the I-SPY2 trial working group chairs. While program
project personnel, cores and projects are tasked with developing and refining the technical and methodological advances
required in the continuous improvement approach employed in I-SPY2.2, all operational aspects of the trial are the
responsibility of the study sponsor. The Program Project overall PIs and project PIs, facilitated by the CAAP core, work
to integrate the changes into the operations of the trial with sponsor representatives by defining the technical
requirements, specifications, and deliverables for the sponsor’s clinical operations team.
Among its other responsibilities, the CAAP Core ensures that our patient advocates are represented on all project teams,
cores teams and inter-project collaborations, so that they can bring their unique and important perspective to help meet the
patient-centric mandate of I-SPY2.2.
Specific Aim 1: Organize, integrate, and provide administrative management of all Projects and Core
Specific Aim 2: Provide project management oversight to track milestones and timelines of the individual Projects and
Cores.
Specific Aim 3: Facilitate collaborations and disseminate information

## Key facts

- **NIH application ID:** 10628613
- **Project number:** 2P01CA210961-06A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** LAURA J ESSERMAN
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $266,572
- **Award type:** 2
- **Project period:** 2017-09-08 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10628613

## Citation

> US National Institutes of Health, RePORTER application 10628613, Core 3: Communications, Administrations, Advocacy, and Project Management (2P01CA210961-06A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10628613. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*