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Integrated Clinical and Research Ensemble Awards 2021

RFA Focus: Novel Approach to Clinical Problems in Cardiovascular Disease

Funding Overview

The CTSI of Southeast Wisconsin is pleased to open a new cycle of support for the novel Team Science-Guided Integrated Clinical and Research Ensembles (Ensemble). For this RFA, the focus of the Ensemble applications should be on unmet needs that are important problems for patients with cardiovascular disease or at risk for cardiovascular disease. The vision of this award is to organize and leverage clinical/translational research to improve patient health and health care. The mission of an Ensemble is to integrate clinical and research faculty, community stakeholders, and health system representatives in highly innovative and efficient units to address the unmet clinical needs of our patients and our communities, and to assist in translating basic science discoveries into treatments and interventions.

Ensembles are groups that may be comprised of appropriate basic, clinical and translational investigators, clinicians, patients, patient advocacy groups, community stakeholders and health system experts (Figure 1) to provide solutions to unmet health needs emanating from the clinic, community, and laboratory (Figure 2). This design allows for identification of real unsolved patient care problems and provides the opportunity for the Ensemble members to develop a solution to these unmet patient needs.

As an example of this for a cardiovascular-focused Ensemble focusing an unmet need for heart failure patients, the Ensemble might include a patient in heart failure, a PhD scientist interested in heart failure and cardiac regeneration, a clinician who specializes in heart failure, a nurse who coordinates care for patients with heart failure, a representative from the hospital who works on Heart and Vascular Service Line for heart failure care, an epidemiologist interested in heart failure, and a representative from communities at increased risk for heart failure. However, please note that the unique composition of your Ensemble will be driven by the relevant expertise needed to address your unmet medical need.

Figure 1: Ensemble Composition

Figure 2: Functional Relationship of Ensemble, Clinic, Community, and Research Laboratory

Submission Details and Deadlines

Letter of Intent: Due by October 15, 2021
Please send a Letter of Intent (no more than one page) that indicates a team leader and potential team members and describes an important unmet patient medical need. Send Letter of Intent to Mike Anello (manello@mcw.edu) by October 15th, 2021.

Proposal Development
A CTSI Project Manager will be assigned to each team and will provide further details on the Ensemble process and assist in scheduling team meetings and providing guidance on the development of an Ensemble proposal. A successful proposal will (1) describe the importance of the unmet patient medical need, (2) describe a robust team with diverse stakeholder composition, and (3) describe potential products that result from the Ensemble’s research, e.g., a device, clinical process, medication, biomarker, clinical trial, extramural grant, technology, or programmatic shift, etc. Proposals should be 3-5 single-spaced pages and include no more than one page of citations.

Proposal Deadline: Rolling Submission
Teams will develop proposals with the help of CTSI Project Managers. The proposals will be accepted for review once the Project Manager indicates that the proposal is mature. The time required to develop a mature proposal is dependent on each team, but has varied in the past from 4-16 weeks.

Ensemble Review Committee Dates
The review committee will meet as necessary to review mature proposals.

Project Period
There are no end dates for this funding support. Once funding is approved, Ensembles will begin working on the delivery of potential products and provide an annual progress report. The Ensemble Review Committee will evaluate the annual progress report, and contingent upon adequate progress, funding and Project Management support will be approved for another year.

Funded Ensembles
Up to 4 Ensembles will be funded through this mechanism. Funded Ensembles will receive a $50,000 line of credit and the support of a CTSI Project Manager. Available CTSI supports will include: (1) Guidance to Create an Operational Plan, (2) Clinical Trial Protocol Development Support, (3) Clinical Trial Execution Support, (4) Biomedical Informatics Support, (5) Community Engagement & Research Support, and (6) Biostatistics Support.

Eligibility
Investigators at all CTSI partner institutions are eligible to submit a Letter of Intent for this funding.

Questions?
Please contact Mike Anello (manello@mcw.edu) or David Zimmerman (dzimermman@mcw.edu).

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.

PARTNERS

Children's Hospital of WisconsinMarquette UniversityMSOEUWMVersitiVA Medical Center