Clinical Research Priorities

Healthcare is transitioning towards a value-driven model.  Extending the reach of the existing healthcare system to deliver care within neighborhood communities will require development of nontraditional partnerships, including: 1) the retail industry and retail-based clinics; 2) technology companies, especially those with broadly used consumer products (e.g. Apple, Uber); and 3) the fitness industry especially those with large national footprints.  The foci of these partnerships may include clinical care, research, and/or innovation.  These partnerships will closely those found with the pharmaceutical, biotech, and medical device industries.

Retail industry partnerships, specifically with supermarkets and pharmacies, provide the opportunity to design and validate more patient-focused, convenient, accessible, and possibly effective services than offered through the traditional healthcare system.  These partnerships between academic researchers and these companies are needed to understand the financial viability and scalability of these services.  

Our team (UC Health, CCHMC, and 4 UC Colleges) has established the deepest health research partnership to date with a large footprint retailer. Our mission is to perform gold-standard trials and observational research projects.  Our objectives are:

1. Design and validate interventions for chronic diseases through an integrated academic-retail-based healthcare model.
2. Create synergies with our existing campus-wide clinical care and innovation relationships.
3. Stimulate a healthcare research culture and investment within the overall retail industry.

The first trial in the partnership, SuperWIN, will be completed, presented, and published in 2021.  SuperWIN is expected to be the highest quality and most complex clinical research study performed with this industry to date.  It will serve as an international “first” in this high potential area of research.  Of note, planning for the next trial(s) with the company has begun.  It is likely a pharmaceutical company may also join this partnership.  A tripartite partnership between an academic healthcare system, a pharmaceutical giant, and the nation’s largest supermarket chain would be another international “first”.  It is also worth noting that efforts have also begun to create an analogous partnership with one of the world’s largest fitness chains.  The aim would be to begin disrupting the current model of exercise and rehab delivery through a more effective academic-fitness industry model.

2022 Plan: Complete SuperWIN along with publishing a review paper, design paper, and the primary results.  Design the next trial with Kroger along with approval for the required multimillion investment that will be required (much of this may come from a pharma partner).  Continue trial planning with the fitness industry.

Priority Area #2:

Innovation in clinical research conduct products and services has been a core focus for the past 6 years.  Our relationship with the I-Hub and the ability to address entrepreneurial ambitions has been greatly enhanced.  Our team has not only developed new technologies for UC (e.g. Asclepius datamart) but led the onboarding of marketplace technologies (e.g. Complion). 

Most often, the primary goal of academic innovation programs is to provide an ecosystem capable of creating new and independent companies.  Company formation provides the proper organizational structure for building a capable team as well as for raising funding; together this supports the focus and resources needed to develop, support, sell, and scale the innovation.  Successful companies are those which not only satisfy a public need, but result in jobs, income, and other opportunities for the community.  Dr. Steen founded a company in 2019, named High Enroll, LLC.  In 2020, High Enroll launched its first commercial product into the marketplace.  The start-up is now poised for rapid investment, scaling, and fulfillment of this vision.

Priority Area #3:

Our clinical research central service unit helps with research consultation, contracting, clinical research coordinator support, and educational services.  Investigators with HCRI research support needs may reach out to Ms. Stephanie Donnelly, Research Manager, or Dr. Dylan Steen, Director of Clinical Trials and Population Research.  The unit previously offered regulatory services, but due to its success, the HCRI regulatory group was scaled and placed under the IM Academic Research Services umbrella so that all divisions in the department would have access to these services.

Plan 2022: Continue to oversee the unit, ensuring adequate support for HCRI investigators and financial sustainability for the unit.