The UF CTSI’s 2016 accomplishments, recapped below, were included in the two-part January issue of On the Same Page:
As a catalytic hub for translational research, the CTSI leads transformative programs, provides services and resources for research teams, and offers a broad range of training and education opportunities. Last year the CTSI served more than 1,000 investigators, and more than 200 scientific publications were published about research facilitated by CTSI resources.
In 2016, the CTSI developed a three-year strategic plan to operationalize five goals in pursuit of its mission. Highlighted accomplishments toward advancing each goal are summarized below.
CTSI accomplishments reflect the dedication of hundreds of faculty, staff and students from across the university and at partners throughout the state, including Florida State University, the University of Miami and affiliated health care providers through the OneFlorida Clinical Research Consortium.
UF Translational Research Environment
Continuously improving the translational research environment at UF is central to the CTSI’s mission. Notable accomplishments under this goal in 2016 include:
Human Subject Research Taskforce: Informed by peer benchmarking and stakeholder input, the CTSI partnered with key units and institutional leadership to develop a three-year plan for implementing two of the task force’s recommendations for improving human subject research processes: implementing OnCore as an enterprise-level clinical research management system and reorganizing UF’s clinical research resources and administration under a new Office of Clinical Research.
Research Services and Resources: CTSI Service Center teams enhanced and expanded key services and resources for researchers:
- The CTSI Recruitment Center launched to provide coordinated resources, services and consultations to facilitate cohort identification and the recruitment of research participants.
- Mirroring UF’s growth in clinical trials volume — which has more than doubled since 2012 — the Clinical Research Center continued a trend of annual growth in patient visits and protocols. Outpatient visits for 2016 are projected to surpass 5,500, an increase of 21 percent from 2015. The number of protocols increased by 23 percent, with more than 150 protocols active in 2016 — including more than 60 studies involving other Clinical and Translational Science Award institutions.
- To help meet growing demand, CTSI investigational pharmacy services expanded to include compounding and dispensing of biological and gene therapy products, as well as the ability to distribute to research pharmacies across the state.
- The Center for Cellular Reprogramming received an NIH R24 award to establish a Pharmacogenomics iPSC Library and Service resource, and initiated linkage with the newly funded CTSA iPSC Network.
Pilot Support: The CTSI and its programs supported six competitive pilot mechanisms to seed the growth of multidisciplinary investigator-initiated translational research at UF. CTSI-affiliated pilot programs received more than 100 applications and made 35 awards to support projects led by investigators in 10 colleges.
Translational Workforce Training and Education
The CTSI Translational Workforce Development Program built significant momentum in 2016 to advance its goal of leveraging the institute’s leadership, infrastructure, program models and faculty expertise to become a university-wide hub catalyzing new opportunities in translational science graduate education and training. The K College, T Team and F Force concepts have grown to support and convene more than 180 fellows and junior faculty as well as T and F award directors and trainees spanning multiple colleges. New K Awards at UF increased from six to seven per year in 2013-2015 to 14 in 2016, and T32 grants increased from nine in 2014 (supporting 38 predocs and 25 postdocs) to 16 in 2016 (60 predocs and 25 postdocs).
In 2016, the CTSI supported approximately 49 faculty members and trainees across its KL2, TL1, TRACTS and Mentor Academy programs. New programs launched include several diversity initiatives as well as a master’s program in biomedical informatics, with a PhD program in biomedical informatics approved to launch in Fall 2017. In the applied biotech training arena, Arizona became the second state to adopt the Biotechnician Assistant Credentialing Exam developed by the CTSI’s Biotility program.
Learning Health System Initiatives
The past year yielded progress across multiple initiatives designed to strengthen the capacity of UF’s learning health system environment:
Precision Medicine: The UF Health Personalized Medicine Program continued to develop, implement, study and refine methods that allow genetic information to be used as a routine part of patient care. CTSI resources facilitated the launch of a project at UF Health Jacksonville to study a point-of-care pharmacogenetics testing approach to guide clopidogrel therapy for heart stent patients, as well as development of a project to study genomic-assisted proton pump inhibitor use in GI clinics. The program also presented findings from a multisite analysis that showed CYP2C19 genetic testing at seven IGNITE sites significantly reduced the risk of cardiovascular events for heart stent patients with a genetic deficiency.
Translational Pilots: CTSI supported four new projects through its NIH-funded Translational Pilot Program and released a 2017-18 RFA with a focus on learning health system approaches that emphasize engagement of clinicians and integration of translational research into the clinical environment. The CTSI also conducted a survey of UF Health clinicians to assess opportunities and barriers to clinician participation in research.
Quality Improvement Registry: In collaboration with UF Health’s Office of Clinical Quality & Patient Safety, CTS-IT developed the UF Health Quality Improvement Project Registry and CQI Approver, scheduled to deploy in 2017. The CTSI envisions the registry will become a major resource to inform process-improvement pilots. In addition, the CQI Approver app will help streamline approval workflows through an algorithm that notifies users of project approval, incomplete requirements or IRB protocol requirements.
Integrated Data Repository and Consent2Share: The Integrated Data Repository continued to expand, with 5,341 queries in 2016 and data representing more than 830,000 patients. IDR data includes whether patients have agreed to participate in Consent2Share, which offers UF Health patients an opportunity to allow UF researchers to contact them about research studies for which they might be eligible based on information in their electronic health record. Close to 30,000 patients have enrolled to date through internal medicine and medical specialties, family practice, cardiovascular and pediatric clinics, with ongoing expansion underway.
Patient-Reported Outcomes: CTSI Biomedical Informatics Program faculty are collaborating with UF Health IT, Epic, Cerner and nine other universities to integrate patient-reported outcomes into electronic health record workflow as part of an NIH CTSA Collaborative Innovation Award led by Northwestern University.
Statewide and National Collaborations
CTSI made significant strides in expanding statewide and national collaborations to amplify the collective impact of translational research for the state and nation:
OneFlorida: As the coordinating center for the OneFlorida Clinical Research Consortium, the CTSI bridges two national research networks: the CTSA consortium and PCORnet. The OneFlorida consortium facilitated approval of 22 studies through the OneFlorida IRB, supported 19 active studies and created the OneFlorida Data Trust, which was approved by the Patient-Centered Outcomes Research Institute as “research ready” and contains claims and electronic health record data for more than 10 million patients.
Community Engagement: HealthStreet celebrated its fifth year at UF and expanded its outreach to encompass more than 20 counties, with more than 8,400 HealthStreet members enrolled since 2011. HealthStreet faculty collaborated with four CTSA hubs to publish results of the CTSA Trust Project and with 21 CTSA hubs to develop the Our Community, Our Health town hall series as a multisite forum to engage researchers and community members in open dialogue.
Multisite Studies: The CTSI engaged a multisite team to help implement IRB, contracting and site initiation for a UF-led $15 million PCORI randomized pragmatic clinical trial at 45 institutions, and it assembled a liaison team to facilitate UF participation in the new CTSA Trial Innovation Network. CTSI investigators also are leading a CTSA Child Health Acceleration through a Multisite Planning, or CHAMP, pod project focused on primary care screening for adverse childhood experiences.