Welcome Message from Brian R. Smith, MD and John Krystal, MD
Co-Directors of the Yale Center for Clinical Investigation
With continuous funding of the Yale CTSA (renewed in 2011
) and institutional support from, the School of Medicine, Yale Medicine, and the Yale New Haven Health System, this have been a period of tremendous growth and progress. We established a robust infrastructure for clinical and translational research and expanded training and education for the next generation of investigators. As we approach the third renewal of our CTSA, we will continue to focus on training a new generation of interdisciplinary team scientists and facilitating innovative programs and resources to speed the delivery of treatments to improve health.
Clinical and translational research in today’s complex landscape requires a team-based effort that involves partnerships between investigators in different disciplines and from different institutions, as well as with the National Institutes of Health, industry, and the community. YCCI has fostered this environment through such initiatives as the YCCI Scholars program, which provides training and mentoring to junior faculty members from the Schools of Medicine, Nursing, Public Health and Engineering. In addition to research and salary support, this program provides unique opportunities for cross-collaboration that include monthly Research in Progress meetings, where Scholars present their work to Yale’s research community, and guidance by a Career Oversight Committee of senior investigators offering expertise both within and outside of the Scholars’ discipline. Our YCCI Scholars Program, which has provided research and salary support to 137 junior faculty members to date, has been incredibly successful in launching the careers of our faculty. Scholars have gone on to successfully compete for more than 700 grants worth over $400 million, have published over 4,000 papers; moreover, 99 percent remain engaged in research.
Another example of how we strive to create a research-friendly environment came in 2010 when the YCCI met with community leaders from Junta, one of the oldest Latino community-based non-profits in New Haven, and the African Methodist Episcopal Zion Church (AME Zion), one of the oldest African American congregations in the US. The result was the creation of the Yale Cultural Ambassadors Program as an element of the Yale “Help Us Discover” initiative. This new program differed from previously described efforts to engage historically underrepresented minority (URM) communities in research by directly working with local church and advocacy leaders to help raise awareness and educate their communities about the importance of participating in clinical research. They also serve as expert resources, advising Yale investigators on how to reach these underserved populations through study design and recruitment efforts that include culturally sensitive messaging.
Over the past 3 years each study engaging the Cultural Ambassadors has had historically underrepresented population participation ranging from 22-89%, with one exception at 12%. The successes to date have resulted in an MOU with the FDA Office of Minority Health. The focus of the partnership is the development of scientific collaborations, outreach, and educational initiatives, as well as intellectual partnerships between FDA and Yale
YCCI strives to respond to the needs of Yale’s research community and we’re continuously reevaluating our services to seek ways to improve them. Over the past several years, we have made tremendous strides in establishing an informatics infrastructure to seamlessly integrate all components of clinical research. This has increased efficiency, eased the administrative burden of investigators, and facilitated data and biospecimen collection and management. In fact, Yale was the first Epic, Yale’s enterprise-wide electronic health record (EHR), site in the country to link directly to the OnCore clinical trials management system (CTMS) to support research billing compliance. We can also be proud of the research innovations we have helped to achieve in the use of the EHR to support clinical research awareness. In March 2015, the Yale “Help Us Discover program” was greatly enhanced by direct integration with Epic. The decision has allowed us to focus on many direct-to-patient innovations using our EHR, including the development of a direct-to-patient research portal in the MyChart patient portal. With no advertisement, the MyChart research profiles have resulted in over 2,000 new volunteers for clinical trials. More impressive than the number itself is that 76% of those agreeing to be screened have already consented and participated in at least one study, including 36% from URM populations. We have also been an early adopter of the Epic functionality to allow the EHR to auto-match patients for trials and message them directly and anonymously through MyChart. We have used the platform in 15 studies with ~1,900 responses. This has resulted in more than 500 enrolled in clinical studies.
Although we are thrilled with accomplishments of the YCCI, this is a year of transition for us as our founding director, Dr. Robert “Bob” Sherwin, has decided to retire after 44 years of service at Yale. While we know Bob’s shoes will be hard to fill as he has been instrumental in clinical research at Yale for more than four decades, we are looking forward to continuing the incredible work he started at YCCI. We are confident that the next few years will bring even more exciting tools and resources to help investigators at Yale and at institutions around the country conduct research that spans the lifespan and responds to the needs of diverse patient populations. In the meantime, we encourage you to explore our website and learn about all we have to offer.
Brian Smith, MD & John Krystal, MD