Prior to the COVID pandemic, many CTSAs employed face-to-face interactions to conduct most of their community engagement (CE) activities. During the COVID pandemic, such engagement had to be curtailed and alternatives needed to be formulated. In addition, Community Engaged Research (CEnR) teams refocused their efforts to address this public health crisis.

To obtain a general understanding of how CTSAs have conducted CE and CEnR during the COVID pandemic, we invited seven CTSA CE leaders to provide brief field reports of their activities during the pandemic. This included how their approaches to CE and CEnR were modified during the COVID-19 pandemic and key lessons learned.

We found that despite numerous challenges, all seven CTSAs CE cores were able to successfully carry out CE and CEnR. We also found that the fundamental principles of meaningful and authentic stakeholder engagement were of paramount importance during the pandemic. Through virtual approaches, all sites had considerable success in maintaining CE in during the COVID pandemic. They also leveraged existing bi-directional community partnerships to carry out meaningful and impactful research. This included both new COVID CEnR and also innovative approaches to sustain prior non-COVID research.

These findings suggest that academic-community partnerships must be fostered and sustained over the many years so that when such crises emerge, all partners can build on existing trust and mutual respect. The lessons learned and the new tools and approaches developed would be key in addressing any such future public health emergencies.

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.

COVID-19 altered research in Clinical and Translational Science Award (CTSA) hubs in an unprecedented manner, leading to adjustments for COVID-19 research.

CTSA members volunteered to conduct a review on the impact of CTSA network on COVID-19 pandemic with the assistance from NIH survey team in October 2020. The survey questions included the involvement of CTSAs in decision-making concerning the prioritization of COVID-19 studies. Descriptive and statistical analyses were conducted to analyze the survey data.

60 of the 64 CTSAs completed the survey. Most CTSAs lacked preparedness but promptly responded to the pandemic. Early disruption of research triggered, enhanced CTSA engagement, creation of dedicated research areas and triage for prioritization of COVID-19 studies. CTSAs involvement in decision-making were 16.75 times more likely to create dedicated diagnostic laboratories (95% confidence interval [CI] = 2.17–129.39; P < 0.01). Likewise, institutions with internal funding were 3.88 times more likely to establish COVID-19 dedicated research (95% CI = 1.12–13.40; P < 0.05). CTSAs were instrumental in securing funds and facilitating establishment of laboratory/clinical spaces for COVID-19 research. Workflow was modified to support contracting and IRB review at most institutions with CTSAs. To mitigate chaos generated by competing clinical trials, central feasibility committees were often formed for orderly review/prioritization.

The lessons learned from the COVID-19 pandemic emphasize the pivotal role of CTSAs in prioritizing studies and establishing the necessary research infrastructure, and the importance of prompt and flexible research leadership with decision-making capacity to manage future pandemics.

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.

The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials.

ClinicalTrials.gov was reviewed to determine if trial sponsor type had a relationship to time to COVID-19 response, which was defined as the date from disease discovery in Wuhan, China to ClinicalTrials.gov study “First Posted” date.

A total of 673 United States (US) sponsored, interventional study listings were retrieved, of which 293 (43.5%) were Industry-sponsored, 349 (51.9%) were Academic sponsored, and 31 (4.6%) were Other sponsor types. Of the Academic studies, 181 (51.9%) were Clinical and Translational Science Award (CTSA) hubs. The average response time for all sponsor types was 189 days, with Academic sponsors having the shortest average response time of 172.6 days (P < 0.001). CTSA hubs had a significantly (P < 0.001) shorter average response time (168.1 days) compared to all other sponsor types (197.4 days). However, while shorter in duration by 9.4 days, response time was not significantly different from non-CTSA sponsors (177.5 days; P = 0.238). Additionally, ANOVA indicated significant relationships (P < 0.001) between funding type, study phase, number of sites, and enrollment size on response time.

Studies posted with the shortest response time were Academic-sponsored trials and included smaller sized investigations of repurposed approved or investigational drugs for the treatment of COVID-19 symptoms. A small second wave of study postings occurred approximately 4 months later, and included small, unique therapies targeting prevention or treatment of COVID-19.

The objective of this study is to determine whether elevated circulating plasma catecholamine levels significantly impact opioid requirements during the first 24 hours postoperative period in individuals with acute surgical pain.

We retrospectively reviewed 15 electronic medical records (EMRs) from adults 18 years and older, with confirmed elevated plasma catecholamine levels (experimental) and 15 electronic health records (EHRs) from matched-controls for age, gender, race and type of surgery, with a follow up of 24 hours postoperatively.

The total morphine milligram equivalents (MMEs) requirements from the experimental group were not statistically different when compared with controls [44.1 (13 to 163) mg versus 47.5 (13 to 151) mg respectively; p 0.4965]. However, the intraoperative MMEs showed a significant difference, among the two groups; [(experimental) 32.5 (13. to 130) mg, (control) 15 (6.5 to 130) mg; p 0.0734]. The intraoperative dosage of midazolam showed a highly significant positive correlation to the total MMEs (p 0.0005). The subjects with both elevated plasma catecholamines and hypertension used significantly higher intraoperative MMEs compared to controls [34.1 (13 to 130) mg versus 15 (6.5 to 130) mg, respectively; p 0.0292)]. Those 51 years and younger, with elevated circulating levels of catecholamines, required significantly higher levels of both the postoperative MMEs [29.1 (0 to 45) mg versus 12 (0 to 71.5) mg; (p 0.0553)] and total MMEs [544.05 (13 to 81) mg versus 29.42 (13 to 92.5) mg; (p 0.00018), when compared to controls with history of nicotine and alcohol use.

This preliminary study evaluated a biologic factor, which have promising clinical usefulness for predicting analgesic requirements that can drive clinical decisions on acute surgical pain.

Intracerebral hemorrhage (ICH) accounts for around 10% of stroke, but carries 50% of stroke mortality. ICH characteristics and prognostic factors specific to the Stroke Belt are not well defined by race.

Records of patients admitted to the University of Alabama Hospital with ICH from 2017 to 2019 were reviewed. We examined the association of demographics; clinical and radiographic features including stroke severity, hematoma volume, and ICH score; and transfer status with in-hospital mortality and discharge functional status for a biracial population including Black and White patients. Independent predictors of in-hospital mortality and functional outcome were examined using logistic regression.

Among the 275 ICH cases included in this biracial analysis, Black patients (n = 114) compared to White patients (n = 161) were younger (60.6 vs. 71.4 years, P < 0.0001), more often urban (81% vs. 64%, P < 0.01), more likely to have a history of hypertension (87% vs. 71%, P < 0.01), less often transferred (44% vs. 74%, P < 0.01), and had smaller median initial hematoma volumes (9.1 vs. 12.6 mL, P = 0.041). On multivariable analysis, Glasgow Coma Scale (GCS) for White patients (OR 13.0, P < 0.0001), hyperlipidemia for Black patients (OR 13.9, P = 0.019), and ICH volume for either race (Black patients: OR 1.05, P = 0.03 and White patients: OR 1.04, P < 0.01) were independent predictors of in-hospital mortality.

Hypertension is more prevalent among Black ICH patients in the Stroke Belt. The addition of hyperlipidemia to the ICH score model improved the prediction of mortality for Black ICH patients. No differences in in-hospital mortality or poor functional outcome were observed by race.

Trainees and investigators from underrepresented minority (URM) backgrounds face unique challenges to establishing successful careers in clinical and translational research. Structured training for mentors is an important mechanism to increase the diversity of the research workforce. This article presents data from an evaluation of the University of California, San Francisco (UCSF) Center for AIDS Research (CFAR) Mentoring the Mentors program aimed at improving mentors’ competency in working with diverse mentees in HIV research.

Mentors from around the USA who had in one of seven separate 2-day training workshops conducted from 2013 to 2020 were invited to participate in an online evaluation survey of their experiences with the training and their subsequent mentoring activities.

There was a high response rate (80%) among the 226 mentors invited to complete the survey. The 180 respondents were diverse in demographics, professional disciplines, and geographic distribution. Quantitative and qualitative data indicate a lasting positive impact of the training, with sustained improvements documented on a validated measure of self-appraised mentoring competency. Respondents also endorsed high interest in future, follow-up training with continued focus on topics related to mentoring in the context of diversity.

The evaluation of the UCSF CFAR Mentoring the Mentors program showed lasting impact in improving mentoring practices, coupled with high interest in continued in-depth training in areas focused on diversity, equity, and inclusion.

To assess researchers’ experiences working with community advisory boards (CABs) and perceptions of how community member stakeholder feedback impacted the research.

Individual interviews were conducted with researchers (n= 34) who had presented their research to a Mayo Clinic CAB (at MN, AZ, or FL) from 2014 to 2017, with an average interview duration of 10–15 min. Researchers were asked “In what ways did the feedback you received from the CAB influence your research?” A validated, structured, 7-item interview was used to assess domains of the potential influence that CABs had on the research: (1) pre-research (e.g., generated ideas), (2) infrastructure (e.g., budget preparation), (3) research design, (4) implementation (e.g., research recruitment), (5) analysis, (6) dissemination, and (7) post-research. A total mean score was calculated with a possible range of 0–7. In addition, open-ended examples and feedback from researchers in response to each domain were summarized for themes using content analysis.

Researchers reported that the CAB influenced research in the following domains: pre-research (24%), infrastructure (24%), study design (41%), implementation (41%), analysis (6%), dissemination (24%), and post-research activities (18%). The mean total score was = 1.8 (SD = 1.7, range: 0–6). Open-ended responses revealed major themes of CAB helpfulness in generating/refining ideas, identifying community partners, culturally tailored and targeted recruitment strategies, intervention design and delivery, and dissemination.

Findings from this preliminary evaluation indicate that despite positive experiences noted in open-ended feedback, the perceived quantitative impact of CAB feedback on the research was moderate. Bidirectional communication between researchers and community member stakeholders has the potential to make clinical and translational research more relevant and appropriate.

This paper reports on a novel measure, attitudes toward genomics and precision medicine (AGPM), which evaluates attitudes toward activities such as genetic testing, collecting information on lifestyle, and genome editing – activities necessary to achieve the goals of precision medicine.

The AGPM will be useful for researchers who want to explore attitudes toward genomics and precision medicine. The association of concerns about precision medicine activities with demographic variables such as religion and politics, as well as higher levels of education, suggests that further education on genomic and precision activities alone is unlikely to shift AGPM scores significantly.

We wrote items to represent psychological and health benefits of precision medicine activities, and concerns about privacy, social justice, harm to embryos, and interfering with nature. We validated the measure through factor analysis of its structure, and testing associations with trust in the health information system and demographic variables such as age, sex, education, and religion.

The AGPM had excellent alpha reliability (.92) and demonstrated good convergent validity with existing measures. Variables most strongly associated with higher levels of concern with precision medicine activities included: regular religious practice, republican political leanings, and higher levels of education.