# Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC)

> **NIH NIH U24** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $5,057,303

## Abstract

Clinical research comes in many different shapes and sizes, and a robust network must accommodate all trial
types. No single organization can do this work alone. We have a deep commitment to both trial innovation
and collective network capacity within and beyond the CTSA Consortium and have a lengthy history of
supporting this approach. We have demonstrated an exceptional ability to collaboratively innovate and share
tools supporting clinical research coordination, including: global data management, mobile data collection,
recruitment, Electronic Health Record (EHR) research, single IRB coordination, contracting, community
engagement, returning value to participants, eConsent, virtual/remote participation in studies, and EHR
integration with REDCap. We will leverage and expand upon these programs as we are Engaging Cooperative
Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC). We will establish a distributed
alliance of 6 CTSA-aligned coordinating centers to add elastic capacity and broaden expertise to the TIN’s
CCC/DCC infrastructure. Our alliance has 14 expert trialists that can inform the use of integrated approaches
for more efficient clinical research. Additionally, we will partner with the well-established Biostatistics,
Epidemiology, and Research Design (BERD) group and health equity experts to ensure every study has
access to needed expertise starting from study design through analysis. We will broaden the types of
organizations that can readily participate in clinical research across the U.S., including Historically Black
Colleges and Universities (HBCUs), to reach the populations most in need of support. Based on our novel
structure, merging teams from six different coordinating center groups, our TIC’s capacity is both scalable
and matched by expertise to intentionally accommodate all study design types. Led by Gordon Bernard,
MD, Wesley Self, MD, and Christopher Lindsell, PhD, each seasoned in leading and collaborating with
multisite clinical trial networks, ECSTATIC will embrace and draw on diverse expertise to build, test, and share
new resources that will enhance and accelerate rigorous, reproducible research for all CTSAs, to more rapidly
improve human health. Our Specific Aims are to: 1) demonstrate and disseminate novel integrated
approaches for more efficient clinical research including EHR-embedded, remote no-touch, and platform
trials, aligning with study needs; 2) expand and enrich clinical trial capability by increasing potential
participating site Expression of Interest (EOI) reach and readiness support (HBCUs and rural Practice-Based
Research Networks), better process integration with CTSAs, preparing study teams, and broader expert
engagement; 3) innovate clinical trial methodology by creating, evaluating, and disseminating new methods
for risk monitoring, AE reporting, direct EHR to REDCap data capture, and data standards to all CTSAs; and
4) provide a distributed alliance of clinical and data ...

## Key facts

- **NIH application ID:** 10877898
- **Project number:** 5U24TR004437-02
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Gordon Raphael Bernard
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $5,057,303
- **Award type:** 5
- **Project period:** 2023-06-29 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10877898

## Citation

> US National Institutes of Health, RePORTER application 10877898, Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC) (5U24TR004437-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10877898. Licensed CC0.

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