RD490 - Virginia Commonwealth Clinical Research Network Assessment and Planning Report – October 31, 2019 and Response to the Report Prepared by Huron Consulting in Conjunction with the Virginia Commonwealth Clinical Research Network – January 21, 2020

Executive Summary:

*This report was replaced in its entirety by the Virginia Commonwealth Clinical Research Network on January 21, 2020.

In 2019, the Commonwealth of Virginia appropriated funds to George Mason University, in collaboration with Eastern Virginia Medical School, Old Dominion University, the University of Virginia, Virginia Commonwealth University, Virginia Polytechnic Institute and State University, INOVA, and Sentara Health System (together “Named Institutions"), to conceptualize a Virginia Commonwealth Clinical Research Network (“VCCRN") that will facilitate the conduct of clinical trials across institutions and enhance the economic and health impact of clinical trials to Virginians. This funding was used to engage Huron Consulting Group in the development of a strategy and business plan for VCCRN. Huron has extensive experience in clinical research, networks, Cancer Centers, and other research organizations. Huron worked closely with the Named Institutions and stakeholders across the Commonwealth. It assessed our strengths, challenges, and opportunities in clinical research and subsequently formulated a strategy to optimize Virginia clinical research, which has been universally endorsed by stakeholders at a September retreat.

In its assessment, Huron observed that Virginia has many of the assets of peer states; however, it has not reached a comparable level of clinical research activity. The current structure of institutions in Virginia drives institutional efforts and as result there is no individual or entity charged with encouraging and enabling collaborations across the state. Huron recognized that Virginia has two NIH grant-funded Clinical and Translational Science Institutes and two National Cancer Institute-Designated Cancer Centers; however, these mechanisms tend to benefit their home institutions and some affiliates; however, their impact statewide has been limited. In addition, a high percentage of Virginians receive their health care at non-academic health systems which do not tend to view clinical research as an institutional priority. The institutional research partnerships that are in place tend to be complicated by such factors as differences in culture, expertise, and priorities which limit their effectiveness. Commonwealth-sponsored initiatives have been successful in commercialization and start-ups but do not have focused expertise on overcoming barriers to enhancing economic, health and social impact of clinical research. As a result, the collective power of Virginia clinical research on health, disparities and inclusion, workforce, and the economy has not been fully realized, and Virginia continues to lose ground to states that have clinical research platforms to optimize collective capabilities.

Huron concluded that the General Assembly is uniquely positioned to transform clinical research in Virginia. With its backing, a VCCRN could have an unparalleled ability to engage and deliver. The VCCRN would use its state leadership role (“neutral party"), coupled with expertise in clinical research, to bring stakeholders ‘to the table’ in order to find common approaches to shared problems. By building on existing strengths, the result would be a new level of collaboration across research institutes and health systems to conduct clinical research that will advance the health of Virginians and reduce the social determinants of health inequities. This, in turn, would position Virginia to compete more effectively for grants and contracts, conduct meaningful clinical trials, attract top-flight researchers, and develop the workforce. Evidence that this is possible is the Huron engagement itself, during, one stakeholder stated, ‘This is the first time we have all come together and are really ready to work on common solutions to shared problems."

To move forward, Huron recommends funding to formally establish the Virginia Commonwealth Clinical Research Network. This funding will support continuation of the Governance Committee, the hiring of a manager to oversee VCCRN and additional planning of the three initial VCCRN services proposed herein; an interim report will be submitted no later than November 1, 2020 on how these services will be developed with a request for funding. The VCCRN should be housed within the newly proposed organization for innovation and commercialization.

Response of the Virginia Commonwealth Clinical Research Network to the Report Prepared by Huron Consulting (beginning on the 49th page of the PDF):

On October 31, 2019, a report from Huron Consulting was submitted in response to Budget Item 164#1c that funded conceptualization of a “Virginia Commonwealth Clinical Research Network" that would facilitate conduct of clinical trials across institutions and enhance the economic and health impact of clinical trials for Virginians. Since submission of the report, representatives of a majority of the named institutions (University of Virginia, Virginia Commonwealth University, Virginia Polytechnic and State University, Old Dominion, University, William and Mary University, George Mason University, and Eastern Virginia Medical School as well as the Carilion Clinic) have taken the opportunity to discuss the report and offer comments and an alternative recommendation in the attached response.

These institutions are fully committed to the goal of increasing collaboration and coordination in support of the goals outlined by the consultants. We believe that the report understates progress to date which includes two NIH funded Clinical Translational Science Award Centers (CTSA’s) and two National Cancer Institute Designated Cancer Centers, the Virginia Tech Carilion Research Institute, and the Virginia Catalyst. We recommend that in lieu of creating a new organization, the funds build upon existing CTSA capacities.

The stakeholder group recommends funding of $1.14M in FY 2021 and $1.715m in FY 2022 to leverage the expertise and administrative capacity in an existing NIH funded Clinical and Translational Science Award Center. The implementation would enable expansion of the clinical research networks, the development of innovative tools related to data and bio-specimens that would improve competitiveness for further grant funding from NIH and other agencies and organizations including industry, and provide support for institutions that wish to engage in clinical research but currently lack the expertise. The group also recommends funding for competitive grants that would promote multi-institutional research.