Journal of Clinical and Translational Science - Latest issue

Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.

Despite the significant health disparities experienced by lesbian, gay, bisexual, and transgender (LGBT) populations, few investigators affiliated with the National Institutes of Health-funded Clinical and Translational Science Award Programs are conducting research related to this underserved population. We provide recommendations shared during a half-day workshop aimed at increasing researcher readiness to conduct LGBT research. This workshop was presented as part of a series on conducting research with underserved populations offered by the Recruitment, Retention, and Community Engagement Program of the Center for Clinical and Translational Science at the University of Illinois at Chicago. Six LGBT health research experts provided focused presentations. The workshop presentations included a summary of significant health inequality issues, theoretical models relevant to research on LGBT health, best practices in measuring sexual orientation and gender identity, recommendations for recruitment and retention, a discussion of community engagement, and ethical considerations in conducting LGBT research. We provide a summary of recommendations to guide future research, training, and public policy related to LGBT health. The information can increase capacity among Clinical and Translational Science Award affiliated researchers in conducting research in this special population.

Community engagement is considered essential to effectively translate research into practice and is increasingly recognized as a key to successful clinical trial recruitment. Challenges to engaging community stakeholders in research persist and new methods are needed to facilitate meaningful stakeholder involvement. The Community Engagement Studio (CE Studio), a consultative model, has been used at every stage of the research process. Best practices drawn from the model could inform other methods of engagement. Using a mixed-methods approach that included evaluation surveys, impact surveys and interviews, we assessed the CE Studio program. We analyzed data from 75 CE Studios; 65 researchers and 591 community members completed surveys and 10 researchers completed interviews. Surveys indicate that 100% of researchers would request a CE Studio in the future, and 99.3% of community members would participate in a CE Studio again. We identified 6 practices to enhance community engagement in clinical and translational research: early input, researcher coaching, researcher humility, balancing power, neutral facilitator, and preparation of community stakeholders. These best practices may enhance the quality of existing community engagement approaches and improve the effectiveness of translational researchers’ efforts to engage community stakeholders in their work.

The Dissemination and Implementation Research Core, a research methods core from the Clinical and Translation Science Award at Washington University in St. Louis Institute of Clinical and Translational Sciences, developed toolkits about dissemination and implementation (D&I) concepts (e.g., D&I outcomes, strategies). This paper reports on the development of the toolkits. These toolkits respond to 3 identified needs for capacity building in D&I research: resources for investigators new to the D&I field, consolidation of tools, and limitations in local contexts.

Latinos constitute a hard-to-reach minority population in Iowa. We used respondent-driven sampling (RDS) to supplement random digit dialing to recruit Latinos for a community physical activity intervention. RDS yielded a 59% increase in Latino participation in just 2 months, with few demographic differences between RDS and random digit dialing groups. RDS may increase recruitment of underrepresented populations and strengthen community engagement; however, it is not a quick fix for underperforming recruitment methods.

Recruitment and engagement for clinical and translational research is challenging, especially among medically underserved and ethnic or racial minority populations. We present a comprehensive model developed through the Clinical and Translational Science Center at the University of New Mexico (UNM) Health Sciences Center that addresses 3 critical aspects of participant recruitment. The components of the model are: (1) Recruitment from within UNM to UNM-centered studies, (2) recruitment from within UNM to community-based studies, and (3) recruitment from outside UNM to UNM-centered studies. This model has increased research participant recruitment, especially among medically underserved populations, and offers generalizable translational solutions to common clinical and translational research challenges, especially in settings with similar demographic and geographic characteristics.

Potential participants seek information about clinical trials for many reasons, but the process can be challenging. We analyzed 101,249 searches in ResearchMatch Trials Today, a free interface to recruiting trials from ClinicalTrials.gov. Searches from March 2015 to November 2016 included a broad range of conditions and healthy volunteer concepts, including 12,649 unique topics. Trials Today data indicate that it is being used to identify trials on a variety of topics.