Clinical Translational Science Award Hubs Research Articles

Strategies to promote language inclusion at 17 CTSA hubs.

The prioritization of English language in clinical research is a barrier to translational science. We explored promising practices to advance the inclusion of people who speak languages other than English in research conducted within and supported by NIH Clinical Translational Science Award (CTSA) hubs. Key informant interviews were conducted with representatives (n = 24) from CTSA hubs (n = 17). Purposive sampling was used to identify CTSA hubs focused on language inclusion. Hubs electing to participate were interviewed via Zoom. Thematic analysis was performed to analyze interview transcripts. We report on strategies employed by hubs to advance linguistic inclusion and influence institutional change that were identified. Strategies ranged from translations, development of culturally relevant materials and consultations to policies and procedural changes and workforce initiatives. An existing framework was adapted to conceptualize hub strategies. Language justice is paramount to bringing more effective treatments to all people more quickly. Inclusion will require institutional transformation and CTSA hubs are well positioned to catalyze change.

Developing a shared understanding of translational science within CTSA hubs through facilitated retreats: A case study.

Translation of critical and broadly impactful health advancements is stymied by insufficient scientific scrutiny of barriers and roadblocks in the process. The Clinical & Translational Science Award (CTSA) funding opportunity announcement released in July 2021 makes clear the distinction between translational research and translational science (TS) and urges a shift from the former to the latter. This represents a significant shift in the overall scientific direction of the CTSA program and necessitates corresponding shifts in CTSA hub operations. To better support TS, the Team Science Core of the Duke CTSA hub designed and facilitated a virtual retreat for hub personnel that (1) enabled organizational learning about TS and (2) identified anticipated challenges and opportunities. A post-retreat survey was utilized to assess the degree to which the retreat met its stated goals. Our survey received a 62% response rate; 100% of respondents would recommend the session to others. Respondents also reported gains in all areas assessed, with evidence for greater understanding of TS and increased perspective of the value and relevance of TS. In this paper, we provide a roadmap for designing and implementing facilitated TS retreats, which we argue is a key step in TS capacity building through workforce development.

Dissemination and implementation science activities across the Clinical Translational Science Award (CTSA) Consortium: Report from a survey of CTSA leaders.

Dissemination and implementation (D&I) science is not a formal element of the Clinical Translational Science Award (CTSA) Program, and D&I science activities across the CTSA Consortium are largely unknown. The CTSA Dissemination, Implementation, and Knowledge Translation Working Group surveyed CTSA leaders to explore D&I science-related activities, barriers, and needed supports, then conducted univariate and qualitative analyses of the data. Out of 67 CTSA leaders, 55.2% responded. CTSAs reported directly funding D&I programs (54.1%), training (51.4%), and projects (59.5%). Indirect support (e.g., promoted by CTSA without direct funding) for D&I activities was higher - programs (70.3%), training (64.9%), and projects (54.1%). Top barriers included funding (39.4%), limited D&I science faculty (30.3%), and lack of D&I science understanding (27.3%). Respondents (63.4%) noted the importance of D&I training and recommended coordination of D&I activities across CTSAs hubs (33.3%). These findings should guide CTSA leadership in efforts to raise awareness and advance the role of D&I science in improving population health.

Broad-scale informed consent: A survey of the CTSA landscape.

Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule's strict regulatory definition for "broad consent") may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broad-scale informed consent within the Clinical Translational Science Award (CTSA) Program Network. We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing. Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers. While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.

FastPACE Train-the-Trainer: A scalable new educational program to accelerate training in biomedical innovation, entrepreneurship, and commercialization.

The Institute of Medicine recommended the advance of innovation and entrepreneurship training programs within the Clinical & Translational Science Award (CTSA) program; however, there remains a gap in adoption by CTSA institutes. The University of Michigan's Michigan Institute for Clinical & Health Research and Fast Forward Medical Innovation (FFMI) partnered to develop a pilot program designed to teach CTSA hubs how to implement innovation and entrepreneurship programs at their home institutions. The program provided a 2-day onsite training experience combined with observation of an ongoing course focused on providing biomedical innovation, commercialization and entrepreneurial training to a medical academician audience (FFMI fastPACE). All 9 participating CTSA institutes reported a greater connection to biomedical research commercialization resources. Six launched their own version of the FFMI fastPACE course or modified existing programs. Two reported greater collaboration with their technology transfer offices. The FFMI fastPACE course and training program may be suitable for CTSA hubs looking to enhance innovation and entrepreneurship within their institutions and across their innovation ecosystems.