The need to diversify the biomedical research workforce is well documented. The importance of fostering the careers of fledgling underrepresented background (URB) biomedical researchers is evident in light of the national and local scarcity of URB scientists in biomedical research. The Career Education and Enhancement for Health Care Research Diversity (CEED) program at the University of Pittsburgh Institute for Clinical Research Education (ICRE) was designed to promote career success and help seal the “leaky pipeline” for URB researchers. In this study, we aimed to quantify CEED’s effect on several key outcomes by comparing CEED Scholars to a matched set of URB ICRE trainees not enrolled in CEED using data collected over 10 years.

We collected survey data on CEED Scholars from 2007 to 2017 and created a matched set of URB trainees not enrolled in CEED using propensity score matching in a 1:1 ratio. Poisson regression was used to compare the rate of publications between CEED and non-CEED URB trainees after adjusting for baseline number of publications.

CEED has 45 graduates. Seventy-six percent are women, 78% are non-White, and 33% are Hispanic/Latino. Twenty-four CEED Scholars were matched to non-CEED URB trainees. Compared to matched URB trainees, CEED graduates had more peer-reviewed publications (p=0.0261) and were more likely to be an assistant professor (p=0.0145).

Programs that support URB researchers can help expand and diversify the biomedical research workforce. CEED has been successful despite the challenges of a small demographic pool.

MD-PhD training programs train physician-scientists to pursue careers involving both clinical care and research, but decreasing numbers of physician-scientists stay engaged in clinical research. We sought to identify current clinical research training methods utilized by MD–PhD programs and to assess how effective they are in promoting self-efficacy for clinical research.

The US MD–PhD students were surveyed in April–May 2018. Students identified the clinical research training methods they participated in, and self-efficacy in clinical research was determined using a modified 12-item Clinical Research Appraisal Inventory.

Responses were received from 61 of 108 MD–PhD institutions. Responses were obtained from 647 MD–PhD students in all years of training. The primary methods of clinical research training included no clinical research training, and various combinations of didactics, mentored clinical research, and a clinical research practicum. Students with didactics plus mentored clinical research had similar self-efficacy as those with didactics plus clinical research practicum. Training activities that differentiated students who did and did not have the clinical research practicum experience and were associated with higher self-efficacy included exposure to Institutional Review Boards and participation in human subject recruitment.

A clinical research practicum was found to be an effective option for MD–PhD students conducting basic science research to gain experience in clinical research skills. Clinical research self-efficacy was correlated with the amount of clinical research training and specific clinical research tasks, which may inform curriculum development for a variety of clinical and translational research training programs, for example, MD–PhD, TL1, and KL2.

Little is known about designing research recruitment campaigns that connect with underserved, geographically isolated rural populations. A theoretically informed process is needed to assist research teams and practitioners in their evaluation of Facebook’s feasibility as a recruitment tool and development of online materials for recruiting rural adults into healthcare delivery intervention development studies.

We drew from research and theory in communication and incorporated process analysis techniques to develop replicable procedures for designing and evaluating Facebook campaigns for rural recruitment. We describe our process and illustrate using two case studies.

Campaigns received approximately 1000 link clicks from the target rural demographic and successfully enrolled participants using Facebook as a primary method of recruitment. The rural tobacco intervention development study received a total of 477 link clicks, cost only $155.80, and enrolled three (23%) of its 13 participants from Facebook. The rural mental health intervention development study received a total of 518 link clicks, cost only $233.28, and enrolled 178 participants.

Our process yielded two successful recruitment campaigns. Facebook was an affordable and efficacious strategy for enrolling adults in behavioral research studies on tobacco and mental health. Future work should apply these theoretical techniques to additional study topics and evaluate specific message features associated with recruitment.

The goal of this project was to document the current state of a community-academic partnership, identifying early successes and lessons learned.

We employed qualitative methods, semi-structured interviews and document analysis, from 2 data sources to (1) show how the principles of community-based participatory research are enacted through the activities of Addressing Disparities in Asian Populations through Translational Research (ADAPT) and (2) elucidate the barriers and facilitators to adhering to those principles from the perspectives of the members themselves.

In addition to established community-based participatory research values, understanding individuals’ motivations for participation, the challenges aligning the priorities of community organizations and academic partners, and definitions of success are themes that emerged as key to the process of maintaining this partnership.

As the emphasis on community-academic partnerships grows, there is potential for clinical and translational science awards to use community engagement to facilitate translational research beyond the traditional medical spheres of influence and to forge relationships with affected communities.

SARS-CoV-2 has been found in the heart of COVID-19 patients. It is unclear how the virus passes from the upper respiratory tract to the myocardium. We hypothesized that SARS-CoV-2 is present in the blood of COVID-19 infected patients, spreading to other organs such as heart.

We targeted two viroporins, Orf3a and E, in SARS-CoV-2. Orf3a and E form non-voltage-gated ion channels. A combined fluorescence potassium ion assay with three channel modulators (4-aminopyridine, emodin-Orf3a channel blocker, and gliclazide-E channel blocker) was developed to detect SARS-CoV-2 Orf3a/E channel activity. In blood samples, we subtracted the fluorescence signals in the absence and presence of emodin/gliclazide to detect Orf3a and E channel activity.

In lentivirus-spiked samples, we detected significant channel activity of Orf3a/E based on increase in fluorescence induced by 4-aminopyridine, and this increase in fluorescence was inhibited by emodin and gliclazide. In 18 antigen/PCR-positive samples, our test results found 15 are positive, demonstrating 83.3% concordance. In 24 antigen/PCR-negative samples, our test results found 21 are negative, showing 87.5% concordance.

We developed a cell-free test that can detect Orf3a/E channel activity of SARS-CoV-2 in blood samples from COVID-19-infected individuals, confirming a hypothesis that the virus spreads to the heart via blood circulation.

With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units within an Academic Medical Center (AMC), including those part of the Clinical and Translational Science Award (CTSA) consortium, have provided support for clinicians in navigating these options prior to the pandemic. As such, they were positioned to be a resource for accessing therapies during the COVID-19 public health emergency.

A small survey and a follow-on poll of the national Investigational New Drug (IND)/Investigational Device Exemption (IDE) Workgroup were conducted in October and December 2020 to determine whether CTSA regulatory units assisted in facilitating access to COVID-19 therapies and the extent of pandemic-related challenges these units faced.

Fifteen survey and 21 poll responses were received, which provided insights into the demands placed on these regulatory support units due to the pandemic and the changes required to provide critical support during this and future crises. Key changes and lessons learned included the importance of regulatory knowledge to support the institutional response, the critical need for electronic submission capacity for Food and Drug Administration (FDA) documents, and the nimble reallocation of regulatory and legal resources to support patient access to investigational agents and/or medical devices during the pandemic.

AMC- and CTSA-based regulatory units played a meaningful role in the COVID-19 pandemic but further unit modifications are needed for enabling more robust regulatory support in the future.

Midcareer research faculty are a vital part of the advancement of science in U.S. medical schools, but there are troubling trends in recruitment, retention, and burnout rates.

The primary sampling frame for this online survey was recipients of a single R01 or equivalent and/or K-award from 2013 to 2019. Inclusion criteria were 3–14 years at a U.S. medical school and rank of associate professor or two or more years as assistant professor. Forty physician investigators and Ph.D. scientists volunteered for a faculty development program, and 106 were propensity-matched controls. Survey items covered self-efficacy in career, research, work-life; vitality/burnout; relationships, inclusion, trust; diversity; and intention to leave academic medicine.

The majority (52%) reported receiving poor mentoring; 40% experienced high burnout and 41% low vitality, which, in turn, predicted leaving intention (P < 0.0005). Women were more likely to report high burnout (P = 0.01) and low self-efficacy managing work and personal life (P = 0.01) and to be seriously considering leaving academic medicine than men (P = 0.003). Mentoring quality (P < 0.0005) and poor relationships, inclusion, and trust (P < 0.0005) predicted leaving intention. Non-underrepresented men were very likely to report low identity self-awareness (65%) and valuing differences (24%) versus underrepresented men (25% and 0%; P < 0.0005). Ph.D.s had lower career advancement self-efficacy than M.D.s (P < .0005).

Midcareer Ph.D. and physician investigators faced significant career challenges. Experiences diverged by underrepresentation, gender, and degree. Poor quality mentoring was an issue for most. Effective mentoring could address the concerns of this vital component of the biomedical workforce.

Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups.

We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components.

The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a “storytelling” intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process.

The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

This study uses KL2 scholars’ publications to evaluate the types of research the KL2 program supports and to assess the initial productivity and impact of its scholars.

We illustrate the feasibility of 3 different approaches to bibliometrics, one viable method for determining the types of research a program or hub supports, and demonstrate how these data can be further combined with internal data records.

Gender differences were observed in the types of research scholars undertake. Overall KL2 scholars are performing well, with their publications being cited more than the norm for National Institutes of Health publications. Favorable results were also observed in scholars’ continued engagement in research.

This study illustrates that linking bibliometric data and data categorizing publications along the translational spectrum with a Clinical and Translational Science Award hub’s internal data records is feasible and offers a number of innovative possibilities for the evaluation of a Clinical and Translational Science Award hub’s programs and investigators.

The success of any clinical research team is dependent on hiring individuals with the experience and skill set needed for a specific research project. Strategies to improve the ability of human resource (HR) recruiters to screen and advance qualified candidates for a project will result in improved initiation and execution of the project.

HR recruiters play a critical role in matching research applicants to the posted job descriptions and presenting a list of top candidates to the PI/hiring manager for interview and hiring consideration.

Creating guidelines to screen for applicant qualification based on resumes when clinical research positions have multiple levels of expertise required is a complex process of discovery, moving from subjective rationale for rating individual resumes to a more structured less biased evaluation process. To improve the hiring process of the research workforce, we successfully developed guidelines for categorizing research coordinator applications by level from beginner to advanced.

Through guideline development, we provide a framework to reduce bias and improve the matching of applicant resumes to job levels for improved selection of top candidates to advance for interviewing. Improved applicant to job matching offers an advantage to reduce hiring time, anticipate training needs, and shorten the timeline to active project engagement. These guidelines can form the basis for initial screening and ultimately matching individual qualities to project-specific needs.

Electronic health record (EHR) data have many quality problems that may affect the outcome of research results and decision support systems. Many methods have been used to evaluate EHR data quality. However, there has yet to be a consensus on the best practice. We used a rule-based approach to assess the variability of EHR data quality across multiple healthcare systems.

To quantify data quality concerns across healthcare systems in a PCORnet Clinical Research Network, we used a previously tested rule-based framework tailored to the PCORnet Common Data Model to perform data quality assessment at 13 clinical sites across eight states. Results were compared with the current PCORnet data curation process to explore the differences between both methods. Additional analyses of testosterone therapy prescribing were used to explore clinical care variability and quality.

The framework detected discrepancies across sites, revealing evident data quality variability between sites. The detailed requirements encoded the rules captured additional data errors with a specificity that aids in remediation of technical errors compared to the current PCORnet data curation process. Other rules designed to detect logical and clinical inconsistencies may also support clinical care variability and quality programs.

Rule-based EHR data quality methods quantify significant discrepancies across all sites. Medication and laboratory sources are causes of data errors.

The purpose of this research was to understand the preferences of patients receiving integrative medicine services for return of aggregate study results.

A brief online survey (survey 1) was sent to 341 cancer patients receiving integrative medicine interventions; subsequently, a minimally revised survey (survey 2) was sent to 812 individuals with various medical conditions who had been either research participants in integrative medicine studies (n = 446) or patients (n = 346) of mind–body medicine.

Feedback to a model plain language summary was elicited from survey 1 and survey 2 respondents. Seventy-seven survey recipients (23%) responded to survey 1, and 134 survey recipients (17%) responded to survey 2. The majority of respondents to the surveys were female and 51–70 years of age. Ninety percent of responders to survey 1 and 89% of responders to survey 2 indicated that researchers should share overall results of a study with participants. In terms of the means of result distribution, 37%–47% preferred email, while 22%–27% indicated that, as long as the results are shared, it did not matter how this occurred. Of 38 survey 1 respondents who had previously participated in a clinical trial, 37% had received the results of their study. In survey 2, 63 individuals indicated that they previously participated in clinical trials, but only 16% recalled receiving results.

These results confirm that the majority (89%–90%) of integrative medicine patients are interested in receiving the results of clinical trials. The majority (82%–94%) of respondents felt the model plain language summary of results provided was helpful.