Leveraging CTSA hubs for rapid, large-scale, high-impact research: A case study during a global public health emergency.

As the COVID-19 pandemic took hold in the USA in early 2020, it became clear that knowledge of the prevalence of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among asymptomatic individuals could inform public health policy decisions and provide insight into the impact of the infection on vulnerable populations. Two Clinical and Translational Science Award (CTSA) Hubs and the National Institutes of Health (NIH) set forth to conduct a national seroprevalence survey to assess the infection's rate of spread. This partnership was able to quickly design and launch the project by leveraging established research capacities, prior experiences in large-scale, multisite studies and a highly skilled workforce of CTSA hubs and unique experimental capabilities at the NIH to conduct a diverse prospective, longitudinal observational cohort of 11,382 participants who provided biospecimens and participant-reported health and behavior data. The study was completed in 16 months and benefitted from transdisciplinary teamwork, information technology innovations, multimodal communication strategies, and scientific partnership for rigor in design and analytic methods. The lessons learned by the rapid implementation and dissemination of this national study is valuable in guiding future multisite projects as well as preparation for other public health emergencies and pandemics.

Fostering diversity and a culture of inclusion in clinical research by training and hiring community members as clinical research assistants.

The University of Pittsburgh (Pitt) Clinical and Translational Science Institute (CTSI) and the nonprofit Bidwell Training Center co-developed a new program for translational workforce diversification and development to foster diversity and inclusion in clinical research. The STricklAnd Research Training (START) program provides students in the Medical Assistant program at Bidwell a career path in clinical research. We created a 12-hour didactic package that covers responsible conduct of human subjects research and good clinical practice as an add-on to existing vocational curriculums. Students have the option of completing a clinical research-related externship at Pitt, which includes mentoring, shadowing, and protocol-specific training on a study team whose intention is to hire them as a clinical research assistant. Those who accept a position at Pitt receive continued mentorship, education, and professional development through Pitt CTSI. In the first three cohorts, two of which had access to research externships at Pitt, 92% of students successfully completed the instruction in clinical research. We plan to expand START to new venues to train and hire local community members from diverse backgrounds who can bring their lived experience to research programs.

The Pitt Innovation Challenge (PInCh): Driving Innovation in Translational Research Through an Incentive-Based, Problem-Focused Competition.

PROBLEM: Translational research aims to move scientific discoveries across the biomedical spectrum from the laboratory to humans, and to ultimately transform clinical practice and public health policies. Despite efforts to accelerate translational research through national initiatives, several major hurdles remain. APPROACH: The authors created the Pitt Innovation Challenge (PInCh) as an incentive-based, problem-focused approach to solving identified clinical or public health problems at the University of Pittsburgh Clinical and Translational Science Institute in spring 2014. With input from a broad range of stakeholders, PInCh leadership arrived at the challenge question: How do we empower individuals to take control of their own health outcomes? The authors developed the PInCh's three-round proposal submission and review process as well as an online contest management tool to support the process. OUTCOMES: Ninety-two teams submitted video proposals in round one. Proposals included mobile applications (29; 32%), other information technology (19; 21%), and community program (22; 24%) solutions. Ten teams advanced to the final round, where three were awarded $100,000 to implement their solution over 12 months. In a 6-month follow-up survey, 6/11 (55%) team leaders stated the PInCh helped to facilitate connections outside their normal sphere of collaborators. NEXT STEPS: Additional educational training sessions related to problem-focused research will be developed. The PInCh will be expanded to engage investment and industry communities to facilitate the translation of solutions to clinical practice via commercialization pathways. External organizations and other universities will be engaged to use the PInCh as a mechanism to fuel innovation in their spaces.

Evolution of an innovative approach to the delivery of in-person training in the responsible conduct of research.

The responsible conduct of research (RCR) Center is an innovative, workshop-based approach to research ethics education at the University of Pittsburgh. A flexibly scheduled program of workshops combines the benefits of traditional case-based discussion and in-person instruction with greater accessibility and a broader disciplinary reach. Essential features of the program include a rotating schedule of independent workshops with separate registration, expert speakers, and a dedicated program director position. At an institutional level, this novel response to National Institutes of Health-mandated training requirements increases access to a wide range of interactive RCR training programs and promotes interdisciplinary conversations on research ethics that involves investigators, trainees, and the research community at large.

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR).

The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open-access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web-based tool. Additional easy-to-use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources.