Although it is hard to believe, the Yale Center for Clinical Investigation (YCCI) is now in its second decade providing training resources and support for Yale’s clinical and translational investigators. With the second renewal of the Clinical and Translational Science Award (CTSA), YCCI is well poised to continue supporting innovative science to improve the health of patients everywhere.
In July 2016, the National Center for Advancing Translational Sciences (NCATS) awarded Yale $53.6 million to renew its five-year CTSA. Yale was among the first 12 institutions to receive CTSA funding when the National Institutes of Health established the program in 2006. Today there are more than 60 CTSA-funded hubs across the country. YCCI also receives substantial funding from the School of Medicine to provide investigators with research support and education, as well as support from Yale Medicine (the School of Medicine’s clinical practice) and Yale New Haven Hospital.
“We’ve made incredible strides under the CTSA in establishing a robust infrastructure and resources for investigators,” said Robert J. Alpern, MD, Dean of the School of Medicine. “I’m delighted that CTSA support will allow us to continue to expand our research enterprise to support the acceleration of treatments from the bench to the bedside.”
Reflecting on the First Decade
YCCI was established in 2005 to provide robust infrastructure to support research and educate the next generation of clinician-scientists. It was formed as a result of a strategic planning process that took place in 2004 and identified a need to significantly bolster and support the School of Medicine’s research enterprise. In its first decade, YCCI developed 36 new programs and strategic initiatives that had not existed prior to the CTSA, and made major investments that have expanded or enhanced the resources of 23 additional programs that span the institution. These initiatives have transformed the research landscape at Yale and across Yale New Haven Health. Highlights include:
- The Junior Faculty Scholars Program, which provides protected time for Scholars to focus on research projects as well as mentoring from senior faculty. Since 2006, there have been 123 past or current Scholars who have successfully applied for more than $314 million in independent grant funding and have published more than 2,400 papers. Yale is among the ten top-performing CTSA institutions for NIH career development (K) awards.
- Last year YCCI provided support to approximately 700 faculty members for nearly 4,000 projects.
- Implementation of OnCore, a clinical research management system integrated with Epic, Yale’s health record for laboratory and demographic data, study enrollment and consent, serious adverse events reporting, and financial and billing data.
- Creation of the Help Us Discover database, which now has more than 9,000 patients who have expressed interest in participating in clinical research.
- In March 2015, implementation of the Help Us Discover research tab in MyChart, which allows patients to view open trials and create a research profile. To date, more than 1,753 new volunteers have signed up through MyChart; 1,170 who were referred and screened for specific studies, and 409 who have already participated in studies (including 145 who are underrepresented minorities). To date, only 300 patients have opted out of research.
- Creation of study recruitment services, including a Recruitment Call Center staffed seven days a week; preparation of recruitment materials in English and Spanish; and advertising campaigns featuring ads on the Yale Shuttle Bus system, a location that had never before been utilized for advertising.
- Establishment of the Cultural Ambassadors program, a partnership with Junta for Progressive Action and the African Methodist Episcopal (AME) Zion Church to promote clinical research education and awareness in New Haven’s Hispanic and African American communities. Over the past two years, in studies where Cultural Ambassadors have been engaged, minority participation has not been lower than 12 percent, with an average minority participation ranging between 20 and 65 percent.
- Supported 101 pilot awards for promising research projects that resulted in more than $50 million in grants.
- Achievement of more than 580 percent growth in industry-sponsored trials.
- Establishment of a centralized multicenter trial unit to support investigator-initiated multicenter studies — an economic and efficient alternative to hiring ad hoc staff members who may not have appropriate expertise.
All in all, the CTSA awards have brought more than $156 million in research support to the School of Medicine since 2006; Yale now has over 1,600 open clinical trials. Beyond that, YCCI has created and implemented initiatives that have increased Yale’s capacity to conduct high-quality clinical and translational research, and decreased the administrative burden on investigators so that they can more readily focus on the research itself.
Under the renewal of the CTSA, YCCI and other CTSA hubs are charged with accelerating the discovery, development, and delivery of interventions to improve health outcomes across the lifespan. This task involves:
- Streamlining the study initiation process.
- Collaborating with other CTSA sites as well as with community providers, patients, and industry.
- Promoting teamwork in science.
- Developing effective ways to improve recruitment and retention of clinical trial participants.
YCCI’s application included plans to strengthen the infrastructure connecting investigators with community health providers and stakeholders throughout Connecticut, and expand collaborations with other CTSA sites. Yale’s IT infrastructure will support the creation of a research hub that includes the Schools of Medicine, Nursing, Public Health, and Engineering; Yale Medicine; Yale New Haven Health, and the VA Connecticut Healthcare System. YCCI will also continue to centralize resources to streamline the research process and ease the administrative burdens of conducting clinical trials.
Providing the next generation of clinical and translational researchers with the skills needed to conduct multidisciplinary team science remains a top priority. “I’m very proud of the success of our educational programs to train medical students, physicians, post-doctoral fellows, and junior faculty,” said YCCI Director Robert S. Sherwin, MD, who is PI of the CTSA and the C.N.H. Long Professor of Medicine (Endocrinology). “Continuing these efforts under the CTSA is a critical part of our mission that will have a far-reaching impact going forward.”
During this grant cycle, the number of slots in the TL-1 Multidisciplinary Pre-Doctoral Training Program in Translational Research is expanding from 10 to 20, the maximum number allowable. The KL-2 Mentored Clinical Scholars Program is also expanding from seven partially funded Scholars to nine.
We will be able to track our progress via our system-wide evaluation tracking system. This powerful evaluation tool allows us to track grants; publications; core use; institutional support and investments; pilot awards; community projects; such data related to trainees as educational outcomes, awards, and collaborations; patents; and survey data. These capabilities can be used for reporting to funding agencies — including for the CTSA and Yale’s 22 NIH-funded centers — and institutional reporting. This administrative innovation has the potential to change the way investigators and research staff work, allowing them to track their progress and determine which measures are successful.
Moving forward, YCCI’s focus will be on collaboration — not just across departments, disciplines, and the university, but with patients, community partners, and institutions across the country and around the world. We plan to pursue partnerships with the School of Engineering & Applied Science and the School of Management to develop and market therapeutics that address unmet clinical needs. We will also build upon our strong relationships with community partners and leverage Yale New Haven Health’s more than four million electronic health records to provide investigators with access to a large and diverse patient population for outcomes and clinical research. CTSA support will help transform Yale into a “learning health system” that generates innovative strategies to benefit tomorrow’s patients.