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.

Insufficient recruitment of groups underrepresented in medical research threatens the generalizability of research findings and compounds inequity in research and medicine. In the present study, we examined barriers and facilitators to recruitment of underrepresented research participants from the perspective of clinical research coordinators (CRCs).

CRCs from one adult and one pediatric academic medical centers completed an online survey in April-May 2022. Survey topics included: participant language and translations, cultural competency training, incentives for research participation, study location, and participant research literacy. CRCs also reported their success in recruiting individuals from various backgrounds and completed an implicit bias measure.

Surveys were completed by 220 CRCs. CRCs indicated that recruitment is improved by having translated study materials, providing incentives to compensate participants, and reducing the number of in-person study visits. Most CRCs had completed some form of cultural competency training, but most also felt that the training either had no effect or made them feel less confident in approaching prospective participants from backgrounds different than their own. In general, CRCs reported having greater success in recruiting prospective participants from groups that are not underrepresented in research. Results of the implicit bias measure did not indicate that bias was associated with intentions to approach a prospective participant.

CRCs identified several strategies to improve recruitment of underrepresented research participants, and CRC insights aligned with insights from research participants in previous work. Further research is needed to understand the impact of cultural competency training on recruitment of underrepresented research participants.

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.

Nurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.

A collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.

A pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.

As the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

There is significant interest in the use of angiotensin converting enzyme inhibitors (ACE-I) and angiotensin II receptor blockers (ARB) in coronavirus disease 2019 (COVID-19) and concern over potential adverse effects since these medications upregulate the severe acute respiratory syndrome coronavirus 2 host cell entry receptor ACE2. Recent studies on ACE-I and ARB in COVID-19 were limited by excluding outpatients, excluding patients by age, analyzing ACE-I and ARB together, imputing missing data, and/or diagnosing COVID-19 by chest computed tomography without definitive reverse transcription polymerase chain reaction (RT-PCR), all of which are addressed here.

We performed a retrospective cohort study of 1023 COVID-19 patients diagnosed by RT-PCR at Stanford Hospital through April 8, 2020 with a minimum follow-up time of 14 days to investigate the association between ACE-I or ARB use with outcomes.

Use of ACE-I or ARB medications was not associated with increased risk of hospitalization, intensive care unit admission, or death. Compared to patients with charted past medical history, there was a lower risk of hospitalization for patients on ACE-I (odds ratio (OR) 0.43; 95% confidence interval (CI) 0.19–0.97; P = 0.0426) and ARB (OR 0.39; 95% CI 0.17–0.90; P = 0.0270). Compared to patients with hypertension not on ACE-I or ARB, patients on ARB medications had a lower risk of hospitalization (OR 0.09; 95% CI 0.01–0.88; P = 0.0381).

These findings suggest that the use of ACE-I and ARB is not associated with adverse outcomes and may be associated with improved outcomes in COVID-19, which is immediately relevant to care of the many patients on these medications.

In order to conduct translational science, scientists must combine domain-specific expertise with knowledge on how to identify and cross translational hurdles, and insights on positioning discoveries for the next translational stage. Expert educators from the Clinical and Translational Science Awards (CTSA) Consortium identified 97 knowledge, skills, and abilities (KSAs) important to include in training programs for translational scientists. To assist educators and trainees to use these KSAs, a conceptual model called “Personalized Pathways” was developed that prioritizes KSAs based on trainee background, research area, or phenotype, and expertise on the research team.

To understand how CTSA educators prioritize specific KSAs when developing personalized training plans for different translational phenotypes and to identify areas of similarity and difference across phenotypes.

A web-based, cross-sectional survey of CTSA educators was done. For a selected phenotype, respondents recommended one of four levels of mastery for each of the 97 KSAs. Results were tabulated by frequency, weighted by importance, and divided into tertiles representing high, middle, and lower priority KSAs. Agreement across phenotypes was compared using Krippendorff’s alpha.

Ten KSAs were high training priority for Preclinical, Clinical, and Community-Engaged phenotypes. These address research methods, responsible conduct of research, team building, and communicating research results. Nine KSAs were in the next tertile for priority reflecting KSAs in biostatistics, bioinformatics, regulatory precepts, and translating implications of research findings.

A smaller set of KSAs can be prioritized for training Preclinical-, Clinical-, and Community-Engaged researchers. Future work should explore this approach for other phenotypes.

Understanding how to translate research discoveries into solutions for healthcare improvement is a priority of NIH-funded Clinical and Translational Science Awards (CTSA). This study, supported by one CTSA, aims to capture one process of shaping and implementing innovations to advance the timeliness and patient-centeredness of cardiovascular care. Specifically, we sought to understand a partnership between a private digital health startup company, a university innovation lab, and an academic health system’s cardiology program pursuing this goal.

The collaboration proceeded through clear phases to address the questions and challenges: problem definition, exploration and formalization of the partnership, innovation co-creation and pilot test, and scale-up planning. Phases were punctuated by key decisions, such as forming the partnership, negotiating terms of the partnership, iterating form and features of the innovation, and exploring sufficiency of its value-add for scale-up and sustainment. Key implementation concepts were apparent, including implementation strategies (e.g., champions and iterative trialing) and the implementation outcomes of acceptability, sustainment, and scale-up. Participants identified potential risks of collaboration, reflected on their co-creation process, and the value of engaging stakeholders in innovation design. Findings may inform subsequent collaborations between innovators and translational researchers.

We conducted a case study to understand the partnership; characterize the questions they pursued, their decision points, information and data sources; and identify the challenges and risks. Data were collected through a series of four focus groups with members of each partnering organization. A transdisciplinary research team iteratively worked to condense and synthesize data from audio recorded transcripts into a case narrative.

Effective patient engagement is central to patient-centered outcomes research. A well-designed infrastructure supports and facilitates patient engagement, enabling study development and implementation. We sought to understand infrastructure needs from recipients of Patient-Centered Outcomes Research Institute (PCORI) pilot grant awards.

We surveyed recipients of PCORI pilot project awards on self-perceived strengths in engagement infrastructure through PCORI’s Ways of Engaging-Engagement Activity Tool survey, and interviewed leaders of 8 projects who volunteered as exemplars. Descriptive statistics summarized the survey findings. We conducted a thematic analysis of the interview transcripts.

Of the 50 surveyed pilots, 22 answered the engagement infrastructure questions (44% response rate). Survey and interview findings emphasized the importance of committed institutional leadership, ongoing relationships with stakeholder organizations, and infrastructure funding through Clinical and Translational Science Awards, PCORI, and institutional discretionary funds.

These findings highlight the importance of and how to improve upon existing institutional infrastructure.

The purpose of this article is to describe the process of developing and implementing a transdisciplinary community-based research center, the Center for Health Equity Research (CHER) Chicago, to offer a model for designing and implementing research centers that aim to address structural causes of health inequality.

Scholars from diverse backgrounds and disciplines formed a multidisciplinary team for the Center and adopted the structural violence framework as the organizing conceptual model. All Center activities were based on community partnership. The Center activities were organized within three cores: administrative, investigator development, and community engagement and dissemination cores. The key activities during the first year were to develop a pilot grant program for early-stage investigators (ESIs) and to establish community partnership mechanisms.

CHER provided more than 60 consultations for ESIs, which resulted in 31 pilot applications over the three application cycles. Over 200 academic and community partners attended the community symposium and discussed community priority. Some challenges encountered were to improve communication among investigators, to clarify roles and responsibilities of the three cores, and to build consensus on the definition and operationalization of the concept of structural violence.

There is an increasing need for local hubs to facilitate transdisciplinary collaboration and community engagement to effectively address health inequity. Building consensus around a shared vision among partners is a difficult and yet important step toward achieving equity.