To leverage clinical and translational research to improve patient/community health and health care. This stems directly from the overarching CTSI mission to make the best medicine better, and to get more treatments to more patients, more quickly.
The Ensemble Program’s mission is to integrate clinical and translational research faculty, the community of stakeholders, and health system representatives into highly innovative and efficient teams to address unmet clinical needs of our patients and our communities. As shown in the figure (“Functional Relationship”), such unmet needs may emanate from the clinic, community, and basic science laboratory. This design allows for identification of real/existent unsolved clinical problems and provides the opportunity to use multidisciplinary team science to develop solutions.
The Ensemble Program’s purpose is to nucleate teams around an unmet clinical need and translate research ideas into clinical practice. An Ensemble brings together a broad continuum of stakeholders, and is inclusive of siloed stakeholders, and others that may rarely be brought together to address unmet clinical needs.
The aim of the Ensemble is to ‘democratize’ research participation by recruiting relevant traditional and non-traditional team members to surround an Unmet Patient Medical Need. Potential team members, including patients, community advocates, community representatives, hospital system representatives, clinicians, basic scientists, population scientists, community health experts and other relevant stakeholders come together to (1) form Pre-Ensemble teams, (2) attend scheduled meetings, (3) share expertise/knowledge/ideas, and (4) develop the research questions and consequent research protocols towards resolution of the unmet patient medical need. Additional members are identified if there are gaps in expertise.
Ensemble outcomes are “products” that could be a device, process, medication, assay, biomarker, clinical trial, survey tool, questionnaire, extramural grant, scholarly publication, etc. The special nature of Ensemble composition allows for products to receive feedback from the community, clinic, or basic science lab.
A Pre-Ensemble team begins with one investigator, or a dyad, triad, or greater number of team members, who nucleate around an important unmet patient medical need. These Pre-Ensembles are formed in response to a funding opportunity (Link to Funding Opportunities Page) or in some cases, are formed organically between funding cycles. After formation, these Pre-Ensemble teams work together to submit an Ensemble proposal, which is then reviewed by one of the CTSI Ensemble Review Committees. Pre-Ensembles become “Ensembles” when they are approved for CTSI funding.
A CTSI Project Manager is assigned to each team to assist teams during the “Pre-Ensemble” or general discussion stage and throughout the Ensemble formation, proposal development, and the conduct of research. Successful proposals must: (a) describe the importance of the unmet patient medical need, (b) identify the requisite, robust team of expertise with diverse stakeholder composition and various beneficial resources, e.g., patient cohorts, community partners, tissue samples, data sets, etc., and (c) discuss potential products that result from the research.
The research is supported through our Function/Partner integration strategy, which includes contributions by any relevant CTSI function or structure (e.g., Clinical Trials Office; Adult Translational Research Unit; Community Engagement Consultation Service; Integrating Special Populations; Clinical Research Data Warehouse, BERD; or the recent CTSI/MSOE Deep Learning Initiative, etc.).
In general, Ensemble RFAs are open to the formation of Pre-Ensembles addressing any unmet patient medical need. However, in September 2021, the Ensemble Function integrated with the Department of Medicine’s Cardiovascular Academic Initiative to release an RFA for “Focused Ensembles” to stimulate the formation of Pre-Ensembles around cardiology-focused unmet patient medical needs. The approved Ensembles from this RFA are collectively known as an Integrated Clinical and Research Cluster. As shown in the figure, an “Ensemble Cluster” is defined as several ensembles, each addressing a different issue within a given field. These Ensembles are supported by a senior investigator, referred to as “translationist” with expertise and track record in inter/trans-disciplinary research. Michael Widlansky, MD, MPH (Professor of Cardiovascular Medicine) is director of the Cardiovascular Academic Initiative and translationist for this Ensemble Cluster.
As shown in the figure, the Ensemble Program debuted in July 2019 with the formation of 10 Pre-Ensembles who submitted funding proposals. In February of 2020, CTSI approved the first 8 Ensembles (ICRE) for funding with a $50,000 “Line of Credit.” Ensembles do not receive grant awards. Rather, they are provided with a line of credit, which they access as needed, through requests via their assigned project manager. To date, a total of 52 Pre-Ensembles have formed around a variety of unmet patient medical needs; 22 of these teams have been granted Ensemble status through various Ensemble funding opportunities, and two Ensembles are no longer active. The unmet patient medical needs of each of the current Ensembles are shown in the table, and include the following areas: Cardiovascular, Surgical, Oncological, Pediatric/Prenatal, and Social Determinants of Health and Special Populations/Underrepresented Minority Disparities.
AFIB & HTN
COVID Extrapulmonary Tissue Damage
COVID Long-term Physical Effects
Pediatric Undiagnosed & Rare Diseases
Muslim End-of-Life Healthcare
Obesity & Food Insecurity
Pediatric ICU/Complex Care
Preconception to Toddler Health
Rotator Cuff Surgery Recovery
Community Screening & SDOH
THC/CBD Use in Pregnancy: Bioethics
Traumatic Brain Injury
Vehicle Crash Test – Male/Female Equity
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.