As clinical researchers at academic medical institutions across the United States increasingly manage complex clinical databases and registries, they often lack the statistical expertise to utilize the data for research purposes. This statistical inadequacy prevents junior investigators from disseminating clinical findings in peer-reviewed journals and from obtaining research funding, thereby hindering their potential for promotion. Underrepresented minorities, in particular, confront unique challenges as clinical investigators stemming from a lack of methodologically rigorous research training in their graduate medical education. This creates a ripple effect for them with respect to acquiring full-time appointments, obtaining federal research grants, and promotion to leadership positions in academic medicine. To fill this major gap in the statistical training of junior faculty and fellows, the authors developed the Applied Statistical Independence in Biological Systems (ASIBS) Short Course. The overall goal of ASIBS is to provide formal applied statistical training, via a hybrid distance and in-person learning format, to junior faculty and fellows actively involved in research at US academic medical institutions, with a special emphasis on underrepresented minorities. The authors present an overview of the design and implementation of ASIBS, along with a short-term evaluation of its impact for the first cohort of ASIBS participants.

As the USA and the rest of the world raced to fight the COVID-19 pandemic, years of investments from the National Center for Advancing Translational Sciences allowed for informatics services and resources at CTSA hubs to play a significant role in addressing the crisis. CTSA hubs partnered with local and regional partners to collect data on the pandemic, provide access to relevant patient data, and produce data dashboards to support decision-making. Coordinated efforts, like the National COVID Cohort Collaborative (N3C), helped to aggregate and harmonize clinical data nationwide. Even with significant informatics investments, some CTSA hubs felt unprepared in their ability to respond to the fast-moving public health crisis. Many hubs were forced to quickly evolve to meet local needs. Informatics teams expanded critical support at their institutions which included an engagement platform for clinical research, COVID-19 awareness and education activities in the community, and COVID-19 data dashboards. Continued investments in informatics resources will aid in ensuring that tools, resources, practices, and policies are aligned to meet local and national public health needs.

Public distrust in the US pandemic response has significantly hindered its effectiveness. In this community-based participatory research mixed-methods study, based on two datasets, we examined how distrust in COVID-19 vaccines relates to institutional distrust. We found that the Johnson & Johnson vaccine pause undermined trust in COVID-19 vaccines in general. Findings also suggest that vaccine distrust developed after participating in a study on COVID-19 testing. Increased distrust may be an unintended consequence of how healthcare and public health activities are presented and delivered, and research participation is structured. Both will continue without proactively addressing the root causes of distrust.

Observational studies are notoriously susceptible to bias, and parallel-group randomized trials are important to identify the best overall treatment for eligible patients. Yet, such trials can be expected to be a misleading indicator of the best treatment for some subgroups or individual patients. In selected circumstances, patients can be treated in n-of-1 trials to address the inherent heterogeneity of treatment response in clinical populations. Such trials help to accomplish the ultimate goal of all biomedical research, to optimize the care of individual patients.

Well-designed, accessible short-term research training programs are needed to recruit and retain underrepresented persons into clinical and translational research training programs and diversify the workforce. The Michigan Institute for Clinical and Health Research developed a summer research program, training over 270 students in 15 years. In response to the 2020 COVID-19 pandemic, we pivoted swiftly from an in-person format to a fully remote format. We describe this process, focusing on factors of diversity, equity, and inclusion including enabling student participation in remote research activities. We collected data about students’ learning experiences since the program’s inception; therefore, we could evaluate the impact of remote vs. in-person formats. We examined data from five cohorts: three in-person (2017–2019; n = 57) and two remote (2020–2021; n = 45). While there was some concern about the value of participating in a remote format, overall students in both formats viewed the program favorably, with students in the remote cohorts rating some aspects of the program significantly more favorably. In addition, more students who identified as Black or African American participated in the remote format than in the in-person format. We describe lessons learned from this unprecedented challenge and future program directions.

In recent times, there have been calls from within the developing nations for increased ownership by governmental research bodies and universities of the priority research setting and research that aligns with national health strategies. This is a review paper of the studies that have been published on clinical trials in developing countries, with a focus mainly on Pakistan. The literature review used online databases such as PubMed, Scopus, and Google Scholar, World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and ClinicalTrials.gov trial registries to search for clinical trials conducted in Pakistan between January 2000 and December 2022 and analyzed. The results revealed that clinical research in Pakistan is hindered by a number of barriers, including a lack of funding, skilled personnel, and regulatory issues. Lack of funding is a common obstacle, and the majority of funding for clinical trials originates from Western countries or pharmaceutical companies established in the West. In conclusion, clinical studies in developing countries, especially in Pakistan, are hindered by a plethora of barriers, and to improve the current state, increasing funding, streamlining ethical approval procedures, simplifying regulatory systems, addressing cultural and religious concerns, and participating in global efforts to bridge the gap in health-based research are crucial.

Museum engagement may be an effective approach for decreasing social disconnection and pain among individuals living with chronic pain. In October 2019, we launched a randomized controlled trial to assess the feasibility of museum engagement for individuals living with chronic pain; the study was halted in March, 2020 due to Covid-19-related safety concerns. This paper describes the process of transitioning from in-person to virtual museum programing in order to continue the study. Virtual museum programing is a feasible option for individuals living with chronic pain that is amenable to research and which may improve accessibility, inclusivity, and scalability relative to in-person programing.

Commercializing biomedical discoveries is a challenging process for many reasons. However, Academic Medical Centers (AMC) that have teaching, patient care, research, and service engrained in their mission are well poised to host these discoveries. These academic discoveries can lead to improvement in patient health and economic development if supported to cross the “valley of death” through institutional assistance, by providing guidance, gap funding and product development expertise. Colorado has a vibrant local startup ecosystem, state support for commercialization and entrepreneurship as well as critical mass of product development expertise. University of Colorado Anschutz Medical Campus, as a major AMC, is an engine for growth for the region. This article discusses innovation efforts at the University of Colorado Anschutz Medical Campus as a case study, which is built around two major efforts: the CCTSI and CU Innovations. I-Corps at CCTSI and the SPARK|REACH program of CU Innovations have been instrumental in fostering innovation, commercialization, and entrepreneurship on the campus.

Leadership is an essential competency for clinicians; however, these skills are not a standard part of health professionals’ education and training. Access to resources (time, money) is frequently cited as a barrier for clinicians to participate in leadership development programs. We aimed to tackle this barrier within postgraduate health professions education and training through establishing an online e-Leadership Academy. The e-Leadership Academy was developed as a community–academic partnership between Clinical Directors Network, Inc. (CDN) and the Harvard Medical School Center for Primary Care to train clinicians and healthcare staff in the fundamental concepts and skills for leading within a clinical practice. For this article, the primary outcome analysis examined participants’ responses to both formative and summative evaluations that took place throughout and at the end of the course. Results were used to assess course quality, participant satisfaction, participant engagement, and provide recommendations about future course offerings for a similar audience. The authors propose that future training programs could measure the changes in team behavior and clinical outcomes using expanded evaluations. Proposed plans for expansion of the e-Leadership Academy include developing additional modules, virtual coaching and mentoring, and the potential integration of an in-person component.

Rapid whole genome sequencing (rapid WGS) is a powerful diagnostic tool that is becoming increasingly practical for widespread clinical use. However, protocols for its use are challenging to implement. A significant obstacle to clinical adoption is that laboratory certification requires an initial research development phase, which is constrained by regulations from returning results. Regulations preventing return of results have ethical implications in cases which might impact patient outcomes. Here, we describe our experience with the development of a rapid WGS research protocol, that balanced the requirements for laboratory-validated test development with the ethical needs of clinically relevant return of results.

OBJECTIVES/SPECIFIC AIMS: Tissue engineered tracheal grafts (TETG) could provide a life-saving cure for children with long segment airway defects. Computational fluid dynamics (CFD) is a novel and promising technique used to evaluate TETG performance. This pilot study examines the correlation of objective CFD simulations with subjective respiratory symptoms in a TETG large animal model. METHODS/STUDY POPULATION: Three-dimensional geometries of 1 TETG implanted sheep trachea were reconstructed from serial fluoroscopic images, allowing analysis with CFD simulations. Peak flow velocity (PFV) and peak wall shear stress (PWSS) across the graft as well as changes secondary to stenting were determined. CFD metrics were compared with respiratory symptoms seen on exam. RESULTS/ANTICIPATED RESULTS: Two weeks after implantation, the animal developed respiratory distress, which correlated with PFV and PWSS elevations. Although the intraluminal graft appearance changed minimally after dilation, PFV and PWSS decreased across the graft (4.5–0.8 m/s and 0.9–0.1 Pa, respectively). Long-term TETG stenting with dilation returned PFV and PWSS to baseline (0.8–0.3 m/s and 0.1–0.01 Pa, respectively), which correlated with immediate symptom resolution. DISCUSSION/SIGNIFICANCE OF IMPACT: CFD is a noninvasive modality, which allows the evaluation of airflow metrics of symptomatic TETG recipients. This diagnostic tool will permit planned interventions and graft design optimization.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer’s Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.