Shared decision-making (SDM) is a critical component of delivering patient-centered care. Members of vulnerable populations may play a passive role in clinical decision-making; therefore, understanding their prior decision-making experiences is a key step to engaging them in SDM.

To understand the previous healthcare experiences and current expectations of vulnerable populations on clinical decision-making regarding therapeutic options.

Clients of a local food bank were recruited to participate in focus groups. Participants were asked to share prior health decision experiences, explain difficulties they faced when making a therapeutic decision, describe features of previous satisfactory decision-making processes, share factors under consideration when choosing between treatment options, and suggest tools that would help them to communicate with healthcare providers. We used the inductive content analysis to interpret data gathered from the focus groups.

Twenty-six food bank clients participated in four focus groups. All participants lived in areas of socioeconomic disadvantage. Four themes emerged: prior negative clinical decision-making experience with providers, patients preparing to engage in SDM, challenges encountered during the decision-making process, and patients’ expectations of decision aids. Participants also reported they were unable to discuss therapeutic options at the time of decision-making. They also expressed financial concerns and the need for sufficiently detailed information to evaluate risks.

Our findings suggest the necessity of developing decision aids that would improve the engagement of vulnerable populations in the SDM process, including consideration of affordability, use of patient-friendly language, and incorporation of drug–drug and drug–food interactions information.

Evaluating clinical and translational research (CTR) mentored training programs is challenging because no two programs are alike. Careful selection of appropriate metrics is required to make valid comparisons between individuals and between programs. The KL2 program provides mentored-training for early-stage CTR investigators. Clinical and Translational Awards across the country have unique KL2 programs. The evaluation of KL2 programs has begun to incorporate bibliometrics to measure KL2 scholar and program impact.

This study investigated demographic differences in bibliometric performance and post-K award funding of KL2 scholars and compared the bibliometric performance and post-K award federal funding of KL2 scholars and other mentored-K awardees at the same institution. Data for this study included SciVal and iCite bibliometrics and National Institutions of Health RePORTER grant information for mentored-K awardees (K08, K23, and KL2) at Case Western Reserve University between 2005 and 2013.

Results showed no demographics differences within the KL2 program scholars. Bibliometric differences between KL2 and other mentored-K awardee indicated an initial KL2 advantage for the number of publications at 5 years’ post-matriculation (i.e., the start of the K award). Regression analyses indicated the number of initial publications was a significant predictor of federal grant funding at the same time point. Analysis beyond the 5-year post-matriculation point did not result in a sustained, significant KL2 advantage.

Factors that contributed to the grant funding advantage need to be determined. Additionally, differences between translational and clinical bibliometrics must be interpreted with caution, and appropriate metrics for translational science must be established.

Senior Instructors and Assistant Professors in their first academic appointment may not have all the tools for an efficient start to their careers. Although many institutions provide access to mentoring programs and seminars on faculty development, the timing and format of the offerings often conflict with ongoing responsibilities of the faculty, particularly clinical faculty.

We established a collaboration between the Clinical and Translational Science Institute (CTSI) and the University of Rochester Medical Center Office for Faculty Development with the goal of developing a week-long Junior Faculty Core Curriculum that would better suit faculty schedules. We convened focus groups and with their help, identified themes for inclusion in the course. Speakers were identified from among local senior faculty. University leadership was enlisted in promoting the course. Individual speakers and course content were evaluated daily, at the end of the week-long course, and 6 months later. Planning for subsequent years incorporated the feedback. Yearly evaluations and subsequent course modification continued.

Junior faculty from nearly every department in the Medical Center were represented. There was high learner satisfaction and participation however several limitations were identified and addressed in subsequent years. The focus on principles and available resources, not specific skills or content was appropriate. Daily interactions among participants from a wide variety of departments fostered networking among faculty who may not otherwise have met and discussed common interests

The ultimate value of such an early, intensive faculty development program will depend on whether it equips junior faculty to organize, develop, and achieve their academic goals better than alternative formats. This will require further study.

The coronavirus disease 2019 (COVID-19) created major disruptions at academic centers and healthcare systems globally. Clinical and Translational Science Awards (CTSA) fund hubs supported by the National Center for Advancing Translational Sciences provideinfrastructure and leadership for clinical and translational research at manysuch institutions.

We surveyed CTSA hubs and received responses from 94% of them regarding the impact of the pandemic and the processes employed for the protection of research personnel and participants with respect to the conduct of research, specifically for studies unrelated to COVID-19.

In this report, we describe the results of the survey findings in the context of the current understanding of disease transmission and mitigation techniques.

We reflect on common practices and provide recommendations regarding lessons learned that will be relevant to future pandemics, particularly with regards to staging the cessation and resumption of research activities with an aim to keep the workforce, research participants, and our communities safe in future pandemics.

A growing number of biomedical doctoral graduates are entering the biotechnology and industry workforce, though most lack training in business practice. Entrepreneurs can benefit from venture creation and commercialization training that is largely absent from standard biomedical educational curricula. The NYU Biomedical Entrepreneurship Educational Program (BEEP) seeks to fill this training gap to prepare and motivate biomedical entrepreneurs to develop an entrepreneurial skill set, thus accelerating the pace of innovation in technology and business ventures.

The NYU BEEP Model was developed and implemented with funding from NIDDK and NCATS. The program consists of a core introductory course, topic-based interdisciplinary workshops, venture challenges, on-line modules, and mentorship from experts. Here, we evaluate the efficacy of the core, introductory course, “Foundations of Biomedical Startups,” through the use of pre/post-course surveys and free-response answers.

After 2 years, 153 participants (26% doctoral students, 23% post-doctoral PhDs, 20% faculty, 16% research staff, 15% other) have completed the course. Evaluation data show self-assessed knowledge gain in all domains. The percentage of students rating themselves as either “competent” or “on the way to being an expert” in all areas was significantly higher post-course (P < 0.05). In each content area, the percentages of participants rating themselves as “very interested” increased post-course. 95% of those surveyed reported the course met its objectives, and 95% reported a higher likelihood of pursuing commercialization of discoveries post-course.

NYU BEEP can serve as a model to develop similar curricula/programs to enhance entrepreneurial activity of early-stage researchers.

In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators.

The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken.

Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines.

The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.

Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens.

A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery.

Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology.

The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.

This study explored the effects of integrating community members into the evaluation of clinical and translational science grants.

The University of California, Irvine Institute for Clinical and Translational Sciences (ICTS) engaged 21 community reviewers alongside scientific reviewers in a 2-stage process of evaluating research proposals. In Stage 1 reviewers scored proposals, and during Stage 2 two study sections convened: one a mix of community reviewers and scientific reviewers, and one only engaging scientific reviewers. In total, 4 studies were discussed by both study sections.

Comparisons of reviews revealed little difference between ratings of community reviewers and those of scientific reviewers, and that community reviewers largely refrained from critiquing scientific or technical aspects of proposals.

The findings suggest that involving community reviewers early in the grant cycle, and exposing them to the entirety of the review process, can bolster community engagement without compromising the rigor of grant evaluations.

Clinical and Translational Award (CTSA) programs are developing relevant training for researchers and community stakeholders participating in community-engaged research (CEnR). However, there is limited research exploring the ways community stakeholders and partners with key CEnR experiences can inform and shape training priorities for prospective CEnR scholars to build meaningful and equitable partnerships.

This study conducted and analyzed online individual semi-structured in-depth interviews with community stakeholders (n = 13) engaged in CEnR to identify training priorities for graduate students and emerging scholars.

Thematic analysis of 13 interview transcripts revealed four major training priorities for prospective scholars interested in engaging in CEnR: 1) researcher’s positionality, 2) equitable power sharing, 3) funding, and 4) ethics.

Building equitable research partnerships was a central theme woven across all four training priorities. Further research should focus on examining the development, implementation, and evaluation of CEnR training in partnership with community stakeholders and partners with relevant CEnR experience. Adopting a collaborative approach to incorporate both community stakeholders and researchers’ priorities can align training competencies to better prepare scholars to engage in building research partnerships.

The effectiveness of community-based participatory research (CBPR) partnerships to address health inequities is well documented. CBPR integrates knowledge and perspectives of diverse communities throughout the research process, following principles that emphasize trust, power sharing, co-learning, and mutual benefits. However, institutions and funders seldom provide the time and resources needed for the critical stage of equitable partnership formation and development.

Since 2011, the Detroit Urban Research Center, collaborating with other entities, has promoted the development of new community–academic research partnerships through two grant programs that combine seed funding with capacity building support from community and academic instructors/mentors experienced in CBPR. Process and outcomes were evaluated using mixed methods.

From 2011 to 2021, 50 partnerships received grants ranging from $2,500 to $30,000, totaling $605,000. Outcomes included equitable partnership infrastructure and processes, innovative pilot research, translation of findings to interventions and policy change, dissemination to multiple audiences, new proposals and projects, and sustained community–academic research partnerships. All partnerships continued beyond the program; over half secured additional funding.

Keys to success included participation as community–academic teams, dedicated time for partnership/relationship development, workshops to develop equity-based skills, relationships, and projects, expert community–academic instructor guidance, and connection to additional resources. Findings demonstrate that small amounts of seed funding for newly forming community–academic partnerships, paired with capacity building support, can provide essential time and resources needed to develop diverse, inclusive, equity-focused CBPR partnerships. Building such support into funding initiatives and through academic institutions can enhance impact and sustainability of translational research toward advancing health equity.

Shared patient–clinician decision-making is central to choosing between medical treatments. Decision support tools can have an important role to play in these decisions. We developed a decision support tool for deciding between nonsurgical treatment and surgical total knee replacement for patients with severe knee osteoarthritis. The tool aims to provide likely outcomes of alternative treatments based on predictive models using patient-specific characteristics. To make those models relevant to patients with knee osteoarthritis and their clinicians, we involved patients, family members, patient advocates, clinicians, and researchers as stakeholders in creating the models.

Stakeholders were recruited through local arthritis research, advocacy, and clinical organizations. After being provided with brief methodological education sessions, stakeholder views were solicited through quarterly patient or clinician stakeholder panel meetings and incorporated into all aspects of the project.

Participating in each aspect of the research from determining the outcomes of interest to providing input on the design of the user interface displaying outcome predications, 86% (12/14) of stakeholders remained engaged throughout the project. Stakeholder engagement ensured that the prediction models that form the basis of the Knee Osteoarthritis Mathematical Equipoise Tool and its user interface were relevant for patient–clinician shared decision-making.

Methodological research has the opportunity to benefit from stakeholder engagement by ensuring that the perspectives of those most impacted by the results are involved in study design and conduct. While additional planning and investments in maintaining stakeholder knowledge and trust may be needed, they are offset by the valuable insights gained.

Because a primary focus of Centers of Biomedical Research Excellence (COBRE) is the development of junior-level investigators into competent and successful research scientists, evaluation of their skills, mentoring experiences, and usefulness of COBRE services is paramount to the transition of the Center to a self-sustaining, collaborative, multidisciplinary research environment. A formative evaluation, focused on the processes of a COBRE, was undertaken and is presented here.

Two instruments, one for completion by junior investigators and one for completion by mentors, were developed for the purpose of evaluating this COBRE. Areas of inquiry were relationships between junior investigators and mentors, research self-efficacy, mentee progress, and satisfaction with the COBRE. All eight of the COBRE’s current junior investigators and six of their mentors completed the online questionnaires.

Junior investigators were very positive about mentors and vice versa. Junior investigators were least positive about their progress as academicians and most positive about their abilities to develop collaborations with other scholars/professionals. Mentors felt as though junior investigators could benefit most by increasing the number of publications they had generated.

Activities provided by the CardioPulmonary Vascular Biology (CPVB) COBRE were extremely positive. Junior investigators felt as though the scientific, academic, and professional development opportunities afforded by this COBRE were integral to their success as researchers; however they would like more assistance developing professional networks (i.e., serving on committees of professional societies). Leadership of the CPVB COBRE may consider expanding the role of their advisory committee to ensure these opportunities are provided.