Community-based organizations (CBOs) are well-positioned to incorporate research evidence, local expertise, and contextual factors to address health inequities. However, insufficient capacity limits use of evidence-based interventions (EBIs) in these settings. Capacity-building implementation strategies are popular, but a lack of standard models and validated measures hinders progress in the field. To advance the literature, we conducted a comprehensive scoping review.

With a reference librarian, we executed a comprehensive search strategy of PubMed/Medline, Web of Science Core Collection, and EBSCO Global Health. We included articles that addressed implementation science, capacity-building, and CBOs. Of 5527 articles, 99 met our inclusion criteria, and we extracted data using a double-coding process

Of the 99 articles, 47% defined capacity explicitly, 31% defined it indirectly, and 21% did not define it. Common concepts in definitions were skills, knowledge/expertise, and resources. Of the 57 articles with quantitative analysis, 48 (82%) measured capacity, and 11 (23%) offered psychometric data for the capacity measures. Of the 99 studies, 40% focused exclusively on populations experiencing inequities and 22% included those populations to some extent. The bulk of the studies came from high-income countries.

Implementation scientists should 1) be explicit about models and definitions of capacity and strategies for building capacity, 2) specify expected multi-level implementation outcomes, 3) develop and use validated measures for quantitative work, and 4) integrate equity considerations into the conceptualization and measurement of capacity-building efforts. With these refinements, we can ensure that the necessary supports reach CBO practitioners and critical partners for addressing health inequities.

Physician-scientist training programs expect applicants to have had extensive research experience prior to applying. Even at the best of times, this leaves individuals from underserved and underrepresented backgrounds at a competitive disadvantage, especially those remote from major academic centers. The COVID-19 pandemic exacerbated that disadvantage by closing research laboratories and suspending summer research opportunities.

The Virtual Summer Research Program (VSRP) was designed to combat this shortfall by helping participating students become better informed and better prepared for applying to MD/DO–PhD programs. 156 participants were recruited from historically black colleges and universities and from national organizations for underrepresented trainees. Participants were paired with medical school faculty members and current MD/DO–PhD students from 35 participating institutions. The program lasted for at least 4 weeks and included a short research project, interactive sessions, journal clubs, social events, and attendance at a regional American Physician Scientists Association conference.

In follow-up surveys, participants reported improvements in their science-related skills and in their confidence in becoming a physician-scientist, applying to training programs, and navigating mentorship relationships. A follow-up study completed one year later indicated that participants felt they had benefited from an enhanced skill set, long-term relationships with their mentors, and connections to the physician-scientist community at large.

The results suggest that VSRP met its primary goals, which were to provide a diverse group of trainees with mentors, provide skills and resources for MD/DO–PhD application and matriculation and to support the development of longitudinal relationships between VSRP mentees and APSA. VSRP provides an approach that can be applied at an even larger scale when the constraints caused by a global pandemic have lifted.

Research is an important aspect of many medical students’ training. However, many medical students are not required to complete a scholarly project, and formal research training is often fragmented across the medical school curriculum. Thus, we developed an online, structured, asynchronous set of modules to introduce trainees to multiple topics relevant to the conduct of research.

Research 101 was piloted by 27 first-year medical students at the University of Cincinnati College of Medicine. Students’ knowledge, confidence, and satisfaction were assessed using a final quiz and pre- and post-module surveys with five-point Likert-scaled questions and open-ended text responses.

Pre-module survey results showed that learners felt most confident in Conducting a literature search and least confident in Submitting an Institutional Review Board (IRB) protocol at UC. Post-module mean scores were significantly increased compared to pre-module results for all modules and questions (P < 0.05). The response to “The content of this module met my needs” was high across all modules with 236 (84.0%) “yes” responses. Thematic analysis of open-ended text responses from post-module surveys identified several improvements to individual modules and to the overall structure of Research 101. A final quiz of 25 multiple choice questions covering content from all required modules was required. The median score was 21.

Comparison of post-module to pre-module survey scores provided clear evidence of improved learning across all topics. The modules developed were responsive to the students’ needs, and students provided additional improvements for subsequent iterations of Research 101.

The COVID vaccine trials illustrated the critical need for the development of mechanisms to serve as a bridge between least advantaged communities and researchers. Such mechanisms would increase the number of studies that are designed with community needs and interests in mind, in ways that will close gaps rather than widen them. This paper reports on the creation of the Community Coalition for Equity in Research, a community-driven resource designed to build community capacity to provide researchers with credible and actionable input on study design and implementation and increase researchers’ understanding of factors that influence community support of research.

We provide a description of the Coalition’s structure and process and an evaluation of its first year of operation. Researchers rated their experience very positively and reported that the Coalition’s review will improve their research. Coalition members reported high levels of satisfaction with their participation and the processes set up for them to engage with researchers. Members also largely agreed that their participation has value for their community, and that it has increased their interest in research and the likelihood that they would recommend research participation to others.

The Coalition represents a model for increasing two-way engagement between researchers and the larger community. We are optimistic that the Coalition will continue to develop and grow into a vibrant entity that will bring value to both investigators and our local communities and will increase the consideration of equity as a foundational principle in all translational research.

A core challenge of a multidisciplinary and multi-organizational translational research enterprise such as a Clinical and Translational Research Award (CTSA) is coordinating and integrating the work of individuals, workgroups, and organizations accustomed to working independently and autonomously. Tufts Clinical and Translational Science Institute (CTSI) undertook and studied a multifacted intervention to address this challenge and to create a culture of systems thinking, process awareness, responsive to others' needs, and shared decision-making.

The intervention, based on relational coordination, included 1) relational interventions, in three staff retreats and a diagnostic survey to provide feedback on the current quality of relational coordination, and 2) structural interventions, in the launching of five new cross-functional teams with regular meeting structures.

A mixed-methods evaluation yielded quantitative data via two types of team surveys and qualitative data via interviews and meeting observations.

The findings suggest that interventions to improve relational coordination are feasible for CTSAs, including good fidelity to the model and staff/physician engagement. Survey and interview data suggest model improvements in coordination and alignment. Further research about their optimal design is warranted.

The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community.

The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance.

Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second.

This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Growing recognition that collaboration among scientists from diverse disciplines fosters the emergence of solutions to complex scientific problems has spurred initiatives to train researchers to collaborate in interdisciplinary teams. Evaluations of collaboration patterns in these initiatives have tended to be cross-sectional, rather than clarifying temporal changes in collaborative dynamics. Mobile health (mHealth), the science of using mobile, wireless devices to improve health outcomes, is a field whose advancement needs interdisciplinary collaboration. The NIH-supported annual mHealth Training Institute (mHTI) was developed to meet that need and provides a unique testbed.

In this study, we applied a longitudinal social network analysis technique to evaluate how well the program fostered communication among the disciplinarily diverse scholars participating in the 2017−2019 mHTIs. By applying separable temporal exponential random graph models, we investigated the formation and persistence of project-based and fun conversations during the mHTIs.

We found that conversations between scholars of different disciplines were just as likely as conversations within disciplines to form or persist in the 2018 and 2019 mHTI, suggesting that the mHTI achieved its goal of fostering interdisciplinary conversations and could be a model for other team science initiatives; this finding is also true for scholars from different career stages. The presence of team and gender homophily effects in certain years suggested that scholars tended to communicate within the same team or gender.

Our results demonstrate the usefulness of longitudinal network models in evaluating team science initiatives while clarifying the processes driving interdisciplinary communications during the mHTIs.

Tumor necrosis factor alpha-induced protein 3 (TNFAIP3) is a multifunctional ubiquitin binding and editing enzyme that regulates inflammation. Genetic studies have implicated polymorphisms within the TNFAIP3 locus to the development of numerous immune-related diseases. This study evaluated the frequencies of single-nucleotide polymorphism (SNPs) within the exonic regions of the TNFAIP3 gene and an associated point mutation from the Illumina array among a predominantly Hispanic cohort.

Genomic DNA was obtained from 721 participants and sequencing of all TNFAIP3 exons and an intergenic point mutation (rs6920220) was performed. In-vitro functional assessment was performed by transfecting mutated TNFAIP3 constructs into TNFAIP3 knockout cells containing the NF-kB luciferase reporter and stimulating with TNFα. Comparative statistics were performed with Student’s t-test for continuous variables and chi-squared test for categorical variables.

Sequencing revealed two missense SNPs, rs146534657:A>G and rs2230926:T>G, both within exon 3 of TNFAIP3, which encodes the protein’s deubiquitinating enzymatic domain. Frequencies of all three point mutations differed significantly across racial groups (χ2-test, P = 0.014 to P < 0.001). Compared to Caucasians, rs146534657:A>G was overrepresented among Hispanics (odds ratio (OR) [95% CI] 4.05 [1.24−13.18]), and rs2230926:T>G was more prevalent among African-Americans (OR [95% CI] 3.65 [1.58−8.43]). In-vitro assays confirm rs146534657:A>G and rs2230926:T>G decrease the ability of TNFAIP3 to abrogate NF-κB activation by 2-fold (P < 0.01) and 1.7-fold (P < 0.01), respectively.

This study reports the frequency of rs146534657:A>G among Hispanics and is the first to evaluate its potential physiologic impact, establishing a basis for future research as a potential biomarker among this population.

Controlled clinical trials (CCTs) have traditionally been limited to urban academic clinical centers. Implementation of CCTs in rural setting is challenged by lack of resources, the inexperience of patient care team members in CCT conductance and workflow interruption, and global inexperience with remote data monitoring.

We report our experience during the coronavirus disease 2019 (COVID-19) pandemic in activating through remote monitoring a multicenter clinical trial (the Study of Efficacy and Safety of Canakinumab Treatment for cytokine release syndrome (CRS) in Participants with COVID-19-induced Pneumonia [CAN-COVID] trial, ClinicalTrials.gov Identifier: NCT04362813) at a rural satellite hospital, the VCU Health Community Memorial Hospital (VCU-CMH) in South Hill, VA, that is part of the larger VCU Health network, with the lead institution being VCU Health Medical College of Virginia Hospital (VCU-MCV), Richmond, VA. We used the local resources at the facility and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network. Investigational pharmacy, pathology, and nursing were essential to operate the work in coordination with the lead institution.

Fifty-one patients with COVID-19 were enrolled from May to August 2020, 35 (69%) at VCU-MCV, and 16 (31%) at VCU-CMH. Among the patients enrolled at VCU-CMH, 37.5% were female, 62.5% Black, and had a median age of 60 (interquartile range 56–68) years.

Local decentralization of this trial in our experience gave rural patients access to a novel treatment and also accelerated enrollment and more diverse participants’ representative of the target population.

The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.

The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned.

The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement.

Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.