Clinical And Translational Science Research Articles

419 A CTS team approach to identifying thematic constructs related to kratom use during pregnancy and breastfeeding: A qualitative analysis of social media posts

OBJECTIVES/GOALS: Research on the safety of perinatal kratom use - an herb that acts on opioid receptors - is scarce. Our transdisciplinary clinical and translational science (CTS) team is conducting parallel qualitative analyses of subreddit posts related to kratom use during (1) pregnancy and (2) breastfeeding. METHODS/STUDY POPULATION: Pregnancy- and breastfeeding-related keywords are being used to extract posts and selected metadata from the following subreddit communities: r/kratom, r/quittingkratom, r/pregnant, and/or r/breastfeeding. After the removal of duplicate posts, posts written in a non-English language and those that state in the post text and/or title that they were published by minors ( RESULTS/ANTICIPATED RESULTS: Among the eligible posts, the number of unique usernames of the sources publishing the posts; the range of publication dates; and the mean, median, & range of the number of comments per post will be presented. Inter-rater concordance in thematic coding will be computed. A word cloud will be created with the most used nouns from the eligible posts. Verbatim quotes will be shown to illustrate themes depicted in the sample. The quantitative and qualitative analyses will be conducted separately for the posts related to kratom use during pregnancy and breastfeeding. DISCUSSION/SIGNIFICANCE: These findings could assist clinicians in identifying questions that obstetric patients may have regarding the perinatal use of this emerging substance of concern. Further research is needed to validate these findings using other social media data, such as Twitter.

146 A Community Engagement Advisory Board’s 22 Years of Contributions to Translational Research

OBJECTIVES/GOALS: CTSIs around the country rely on Community Engagement Advisory Boards (CEABs) to bridge research and communities. The history of this 22-year-old board offers insight on 1) how it was created and has been sustained over time 2) its evolution, and 3) members’views of their contributions to translational research at UIC. METHODS/STUDY POPULATION: As founding members began to step down from this long-standing board, we started to document its history and members’ narratives and perspectives of the work conducted at UIC since its inception. Using an Oral History methodology, we conducted three virtual focus groups with 13 short and long-term members (n=6, n=4, n=3) to learn about changes within CEAB and in members’ roles, and individual semi-structured interviews with three long-standing members to expand on the origin and evolution of CEAB. Focus group data was coded and analyzed. We also extracted data on key events from archived files including grant proposals and CEAB meeting notes. A steering committee of three CEAB members helped guide this process. RESULTS/ANTICIPATED RESULTS: The CEAB was founded at the UIC College of Nursing in 2001 under the Center for Research on Cardiovascular Respiratory Health, with a grant from the National Institutes of Nursing Research (NINR). It was established as college-wide advisory board of community experts to help engage underserved communities and to contribute to research beyond recruitment and retention. In 2009, upon receipt of a Clinical Translational Science award that established the Center for Clinical Translational Science (CCTS), the CEAB became a campus-wide board. Over 30 community organizations and many non-affiliated community members have contributed to translational research at UIC throughout the board’s history. DISCUSSION/SIGNIFICANCE: Over twenty years later, the CEAB continues to help bridge researchers and communities, and to raise awareness about community needs, the importance of cultural relevance, and the inclusion of underserved communities in research. Long-term members have played a key role in providing continuity over the years.

Effect of the population health inpatient Medicare Advantage pharmacist intervention on hospital readmissions: A quasi-experimental controlled study

BACKGROUND: The population health inpatient Medicare Advantage pharmacist (PHIMAP) intervention is a pharmacist-led, transitions-of-care intervention that aims to reduce hospital readmissions among Medicare Advantage beneficiaries. PHIMAP includes inpatient pharmacist participation in interdisciplinary rounds, admission and discharge medication reconciliation, pharmacy staff delivery of discharge medications to the bedside, personalized discharge medication lists and counseling, and communication with outpatient pharmacists through an electronic health record. OBJECTIVE: To evaluate the effect of the PHIMAP intervention on unplanned 30-day same-hospital readmissions among Medicare Advantage patients. METHODS: Those included were patients admitted to a large urban academic medical center between May 2018 and March 2020 who had a Medicare Advantage plan and were aged at least 18 years. A 2-group, quasi-experimental design was utilized. Control patients received the usual care, which included a best possible medication history and a postdischarge phone call. A multivariable logistic regression model was estimated to predict unplanned 30-day same-hospital readmissions. This study was a Hypothesis Evaluating Treatment Effectiveness study. RESULTS: In total, 884 patients were included. The majority were White (59.0%), non-Hispanic (87.7%), English speaking (90.5%), and older adults (median age, 75 years; interquartile range, 70-83 years). We detected no statistically significant association between the PHIMAP intervention and unplanned 30-day same-hospital readmissions (odds ratio [OR] = 0.91, 95% CI = 0.56-1.52). After adjusting for patient demographics and clinical covariates, significant predictors of 30-day readmissions included the number of emergency department/inpatient visits within 180 days prior to index admission (OR = 1.40, 95% CI = 1.11-1.77); discharge to a post-acute care facility, such as an inpatient rehabilitation facility, long-term acute care facility, or skilled nursing facility (OR = 1.69, 95% CI = 1.06-2.66); hospital length of stay in days (OR = 1.04, 95% CI=1.01-1.07); and the Agency for Healthcare Research and Quality Elixhauser Comorbidity Index score (OR = 1.01, 95% CI = 1.01-1.02). CONCLUSIONS: Significant predictors of readmissions among Medicare Advantage beneficiaries were consistent with greater illness severity, including a recent history of prior hospital utilization, a discharge to post-acute care facility (vs home), a longer length of hospital stay, and a higher comorbidity burden. Although we detected no statistically significant association between PHIMAP and unplanned 30-day same-hospital readmissions, differences in study group assignment based on the day of hospital discharge (weekend vs weekday) was a noted limitation of this study. Future studies of inpatient pharmacist-led interventions should plan to minimize the risk of selection bias due to differences in the time of patient discharge. DISCLOSURES: This study was supported in part by the National Institute on Aging under award number R01AG058911 (to Pevnick) and the UCLA Clinical Translational Science Institute (UL1 TR001881). The sponsor had no role in the design and conduct of the study, nor the writing of this report.

Implementing measurable goals for diversity, equity, and inclusion in Clinical and Translational Science Awards leadership

Charting a benchmarking strategy is recommended to measure improvements in equal leadership opportunities for minorities and women in the Clinical Translational Science Awards Consortium (CTSAs). Academic institutions that support diversity, equity, and inclusion (DEI) initiatives should demonstrate a willingness to track their progress with established metrics. In the fall of 2020, the CTSAs convened a virtual conference, which started a dialogue on developing measurable objectives to ensure accountability for DEI goals. Using qualitative and quantitative data from breakout sessions, the authors analyze participant responses to the following recommendation, “ develop a common metric and dashboard with regular reporting on diversity in CTSA leadership, with an emphasis on increasing female and Black Indigenous, People Of Color (BIPOC) representation to 30% each,” to understand the impact and challenges associated with implementing metrics within CTSAs. Thematic analysis revealed that white supremacist culture and demographic composition are obstacles to establishing metrics. Participants expressed uncertainty about the perception of token roles. Additionally, participants believed that DEI targets can increase diversity in perspectives and approaches to translational science. Implications for CTSAs include establishing CTSA-wide benchmarks for DEI initiatives, which includes a baseline of the existing DEI climate to assess institutional norms and measurable objectives to track progress.

Tumor necrosis factor inhibitors and methotrexate are associated with decreased COVID-19-related hospitalization: Follow up of “Clinical outcomes of COVID-19 in patients taking tumor necrosis factor inhibitors and methotrexate”

Tumor necrosis factor inhibitors and methotrexate are associated with decreased COVID-19-related hospitalization: Follow up of “Clinical outcomes of COVID-19 in patients taking tumor necrosis factor inhibitors and methotrexate”

Predicting Treatment Responses in Patients With Osteoarthritis: Results From Two Phase III Tanezumab Randomized Clinical Trials.

Prediction of treatment responses is essential to move forward translational science. Our question was to identify patient-based variables that predicted responses to treatments. We conducted secondary analyses on pooled data from two randomized phase III clinical trials (NCT02697773 and NCT02709486) conducted in participants with moderate to severe osteoarthritis randomized to subcutaneous placebo (n=514) or tanezumab 2.5 mg (n=514). We used gradient boosted regression trees to identify variables that predicted Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale scores at Week 16 and marginal plots to determine the directional relationship between each variable category and responses to placebo or tanezumab within the models. We also used Virtual Twins models to identify potential subgroups of response to the active treatment vs. placebo. We found that responses to placebo were predicted by baseline WOMAC Physical Function, baseline WOMAC Pain, the radiographic classification of the index joint, and the standard deviation of diary pain scores at baseline. In contrast, baseline WOMAC Pain along with failure of prior medications, duration of disease, and standard deviation of diary pain scores at baseline were predictive of tanezumab responses as expressed by the WOMAC Pain scores at Week 16. Those who responded to tanezumab vs. placebo were identified based on the radiographic classification of the index joint and either age or smoking status. These secondary-data analyses identified distinct and common patient-based variables to predict response to placebo or tanezumab. These findings will inform the design of future clinical trials, helping to move forward clinical pharmacology and translational science.

A discussion among deans on advancing community engaged research.

The benefits of community-engaged research (CEnR) have been documented in the literature. However, the adoption of community engaged (CE) and participatory approaches among health researchers remains limited. The Boston University (BU) Clinical Translational Science Institute's community engagement program initiated a discussion among five BU Deans to explore their approaches to support the practice of CEnR among faculty in their schools. The discussion was recorded and the transcript analyzed to identify and explore themes that emerged. Most strategies discussed by the Deans were not focused on changing institutional systems to advance CEnR. Instead, the analyses showed that institutional CE efforts highlighted by the Deans were focused on "responsibility centered on one person" or "research mentors." Approaches to developing a culture of CEnR that centers responsibility for promoting it on a few people in a university may place significant burden on leadership and researchers and is not an effective way to promote culture change. Systems change is needed to support CEnR, improve accountability, and realize successful partnerships between academic institutions and communities. The dialogue among Deans focused on the topic of CEnR provided an effective method to catalyze discussion and over time may help to strengthen a culture of CEnR research.

Clinical and Translational Science Personas: Expansion and use cases.

Twelve evidence-based profiles of roles across the Clinical and Translational Science (CTS) workforce and two patient profiles were developed by CTS Personas collaborators in 2019 as part of the CTSA Program National Center for Data to Health (CD2H). Based on feedback received from the community, CTS Personas team members collaborated to produce five additional Personas to broaden representation of the CTS workforce and enhance the existing portfolio. This paper presents the rationale and methodology used in the latest CTS Personas initiative. This work also includes an implementation scenario incorporating multiple Personas. Using the new National Institutes of Health's (NIH) Data Management and Sharing Policy as an example, we demonstrate how administrators, researchers, support staff, and all CTS collaborators can use the Personas to respond to this new policy while considering the needs of service providers and users, CTS employees with short- and long-term needs, and interdisciplinary perspectives.

Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience.

Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise. Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies. We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.

Abstract B035: Addressing African American physician engagement in decentralized clinical trial by clinical trials and translation science consortium focus group participation

Abstract BACKGROUND: Despite decades of effort and proposed solutions to increase diversity in clinical trial participation, African Americans remain underrepresented. Race-specific review of clinical trial participation challenges suggests that engagement with African American physicians influence successful recruitment and appropriate enrollment of underrepresented groups in clinical research. Tailoring best-practices for minoritized populations cannot be sustainably facilitated without trusted community-academic partnerships. Engagement with African American community physicians creates capacity for leveraging resources critical to participation of African Americans in decentralized clinical trials (DCT). The Northeast Florida Clinical Trials and Translational Science (NEF-CTaTS) Consortium was formed in 2022 to address cancer health disparities experienced by minoritized, marginalized and underserved communities in NE Florida. AIM:The NEF-CTaTS Consortium convened a Focus Group with 22 African American community physicians who care for minoritized patients to solicit their input in fostering active research, research training, community outreach and engagement, and to address advantages of and barriers to forming a research network of minority physicians to conduct decentralized clinical trials and translational research. METHODS: Practicing community primary care physician members of the Northeast Florida Medical Society, a chapter of the National Medical Association where invited to participate. Physician demographic and practice information was collected from physicians who consented to participate prior to the Focus Group discussion. A Clinical Trial Needs Assessment was completed by each participating physician. The Physician Focus Group discussion was moderated by a skilled African American community physician member of the NEF-CTaTS consortium with extensive experience in conducting clinical trials. The discussion was recorded and transcribed for data analysis. IRB approval was obtained prior to informed consent, data collection and Focus Group Discussion. RESULTS: Qualitative analysis of the raw data is currently ongoing at the time of this submission. Transcribed discussion details and the observational notes identified thematic framework for descriptive statements, indexing, and sifting data. Mapping and interpretation of data is being analyzed for relationships, internal consistency, intensity of comments and specificity of responses. Analysis is scheduled to be complete within 4 weeks of abstract submission. CONCLUSIONS: Efforts to appropriately address disparities in clinical trial participation and DCT participation of African Americans require distinct and deliberate efforts to engage African American physician stakeholders. Addressing issues of trust and the impact of social-determinants of health on minoritized populations can be culturally and appropriately addressed by community-academic partnerships. Citation Format: Floyd Willis, Folakemi Odedina, Kim Barbel Johnson, Rogers Cain, Jennifer Crook. Addressing African American physician engagement in decentralized clinical trial by clinical trials and translation science consortium focus group participation [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B035.

Equitable implementation of innovations to promote successful aging in place.

Equitable implementation of innovations to promote successful aging in place.

Accelerating diversity, equity, and inclusion goals: a qualitative assessment from the lens of scientists at the 2020 Clinical Translational Science Awards Annual Meeting.

Participants in the leadership breakout session at the Clinical Translational Science Awards (CTSA) virtual 2020 conference discussed and ranked six recommendations in terms of feasibility, impact, and priority for advancing Diversity, Equity, and Inclusion (DEI) efforts to elevate underrepresented populations to leadership positions in CTSAs and their broader institutions. A thematic analysis of chat and polling data identified challenges and opportunities to achieve DEI goals, with the three most promising recommendations as: cross-institutional Principal Investigator (P.I.) action-learning workgroups, transparent policies for recruiting and promoting underrepresented minorities (URM) leadership, and a clear succession plan to nurture and elevate URM leaders. Suggestions are made to improve DEI in CTSA leadership and allow for greater representation in the translational science field.

Radiation Oncology: Future Vision for Quality Assurance and Data Management in Clinical Trials and Translational Science.

The future of radiation oncology is exceptionally strong as we are increasingly involved in nearly all oncology disease sites due to extraordinary advances in radiation oncology treatment management platforms and improvements in treatment execution. Due to our technology and consistent accuracy, compressed radiation oncology treatment strategies are becoming more commonplace secondary to our ability to successfully treat tumor targets with increased normal tissue avoidance. In many disease sites including the central nervous system, pulmonary parenchyma, liver, and other areas, our service is redefining the standards of care. Targeting of disease has improved due to advances in tumor imaging and application of integrated imaging datasets into sophisticated planning systems which can optimize volume driven plans created by talented personnel. Treatment times have significantly decreased due to volume driven arc therapy and positioning is secured by real time imaging and optical tracking. Normal tissue exclusion has permitted compressed treatment schedules making treatment more convenient for the patient. These changes require additional study to further optimize care. Because data exchange worldwide have evolved through digital platforms and prisms, images and radiation datasets worldwide can be shared/reviewed on a same day basis using established de-identification and anonymization methods. Data storage post-trial completion can co-exist with digital pathomic and radiomic information in a single database coupled with patient specific outcome information and serve to move our translational science forward with nimble query elements and artificial intelligence to ask better questions of the data we collect and collate. This will be important moving forward to validate our process improvements at an enterprise level and support our science. We have to be thorough and complete in our data acquisition processes, however if we remain disciplined in our data management plan, our field can grow further and become more successful generating new standards of care from validated datasets.

Integrating real-world data to accelerate and guide drug development: A clinical pharmacology perspective.

Pharmaceutical products in the current accelerated drug development landscape can benefit from tools beyond data generated from randomized control trials. We have seen an abundance of real‐world data (RWD) and real‐world evidence, driven by the digitalization of healthcare systems and an increased awareness that has inspired a heightened interest in their potential use. Literature review suggest leveraging RWD as a promising tool to answer key questions in the areas of clinical pharmacology and translational science. RWD may increase our understanding regarding the impact of intrinsic (e.g., liver, renal impairment, or genetic polymorphisms) and extrinsic (e.g., food consumption or concomitant medications) factors on the clearance of administered drugs. Changes in clearance may lead to clinically relevant changes in drug exposure that may require clinical management strategies, such as change in dose or dosing regimen. RWD can be leveraged to potentially bridge the gaps among research, development, and clinical care. This paper highlights promising areas of how RWD have been used to complement clinical pharmacology throughout various phases of drug development; case examples will include dose/regimen extrapolation, dose adjustments for special populations (organ impairment, pediatrics, etc.), and pharmacokinetic/pharmacodynamic models to assess impact of prognostic factors on outcomes. In addition, this paper will also juxtapose limitations and promises of utilizing RWD to answer key scientific questions in drug development and articulate challenges posed by quality issues, data availability, and integration from various sources as well as the increased need for multidimensional‐omics data that can better guide the development of personalized and predictive medicine.

0290 Associations between sleep duration and sedentary behavior in healthy, young adults

Abstract Introduction Chronic diseases are more prevalent among populations with greater daily sedentary time and among populations with insufficient sleep duration. Yet, little is known about the potential links between insufficient sleep and sedentary behavior. Early findings from recent studies show variable and bidirectional associations between sleep duration and sedentary behavior, based on the population studied. The purpose of this investigation was to measure associations between: (1) sleep duration and sedentary time the next day; and (2) sedentary time and sleep duration the same study day/night, during a sleep extension intervention. Methods Data collection are ongoing. To date, three participants (2 female; aged 24.7±4.04yr; BMI 21.73±2.38kg/m2) with self-reported habitual insufficient sleep (<6.5h per night) completed the study protocol in its entirety. Sedentary behavior (<1.5 METs, in seated or lying posture) and sleep duration were measured via activPALTM and wrist-actigraphy, respectively, at baseline for days 1-13. After baseline, participants completed a sleep extension intervention for study days 15-41, with sedentary behavior and sleep duration measured during study days 28-41. Only study days with full 24h activPAL™ wear time were included in statistical analyses. Associations between sedentary behavior and nightly sleep duration were analyzed by linear mixed-model regression. We focused this preliminary analysis of 3 participants on R2. Results Sleep duration was significantly increased (p<0.05) during sleep extension (7.6±1.5h) versus baseline (7.0±1.4h). Sedentary behavior was not significantly different (p=0.869) during sleep extension (8.4±1.6h) versus baseline (8.3±2.0h). The association between sleep duration to sedentary time the following day had p=0.683, R2=0.51, and =2.5±6.2h. The association between daily sedentary time to sleep duration the same study day/night had p=0.72, R2=0.12, and =2.3±6.2h. Conclusion Preliminary findings from 3 participants in this ongoing study suggest that sleep extension is not associated with changes in sedentary behavior. Support (If Any) NIH-UL1TR002535, NIH-K01HL145099, Colorado Clinical Translational Science Institute Pilot (CO-J-20-119), University of Utah Seed Grant-10060570

218 Reframing the JTF Clinical Trial Competencies from a CRP Team Science Perspective

OBJECTIVES/GOALS: Our goal is to explore and collaboratively identify the team science competencies essential for Clinical Research Professionals at all experience levels and how these competencies relate to the Joint Task Force for Clinical Translational Research Professionals Competencies. METHODS/STUDY POPULATION: Team science competencies for clinical research professionals are poorly defined. The JTF Clinical Trial Competencies lack sufficient emphasis on team science, though it is briefly included in two JTF competency domains: Leadership & Professionalism, and Communication & Teamwork. The competencies primarily focus on tasks related to clinical research and basic knowledge of product development; however, a conceptual model for applying the competencies using a team science lens is needed. Currently, the JTF competency figure is often thought of as sequential, given the competencies are numbered, creating the misconception that the last competencies are less important. We support a new figure showing the permeability of team science across competencies and the connectedness and equality of the competencies. RESULTS/ANTICIPATED RESULTS: Our anticipated results are to show the integral nature of team science in clinical research professional communities of practice. Once complete, we will have identified measurable team science competency-based skills essential for clinical research professionals at various levels of expertise. Understanding the multi-dimensional team science competencies will inform targeted team science education and training for clinical research professionals. Our revised competency framework provides an improved team science conceptual model for clinical translational science. DISCUSSION/SIGNIFICANCE: Our work will define team science competencies as related to clinical research professionals at all experience levels. The interdependence of teams across clinical trial activities necessitates a consideration of an improved conceptual framework for clinical translational team science competencies.

196 Assessment of Learning Modules Promoting Team Science Practices to the Translational Scientist

OBJECTIVES/GOALS: The overarching objective is to assess the value of promoting team science practices across a diverse clinical translational science community through the development of learning modules. We aim to share lessons learned to help inform best practices for CTSA hubs interested in promoting team science. METHODS/STUDY POPULATION: We recently created a series of self-paced learning modules focused on the science of team science, which include a variety of text and multimedia content. A preliminary assessment was conducted to determine the perceived value of six video team science Learning Shots and to identify areas for improvement. Significant content revisions are underway based on respondent feedback. In early 2022, a follow up survey will solicit feedback from a larger sample of researchers to reassess the learning modules and to ensure that desired improvements were achieved. We will incorporate continuous improvement cycles to gather future feedback, track improvements, and identify potential future direction for new content. RESULTS/ANTICIPATED RESULTS: The preliminary assessment identified the most effective aspects of the modules to be the variety and knowledge of speakers, diversity of topics, organization of the content, and appropriateness of length. Least effective aspects included a desire for more information in some content areas and not enough focus on the challenges of team science for junior faculty. Suggested areas for improvement include a desire for supplemental descriptive text, links to tools that enable teams to be productive, and additional examples from researchers. The follow up study is expected to yield more detailed information on the impacts of the improvements and the overall effectiveness of the modules. DISCUSSION/SIGNIFICANCE: This project provides insights for CTSA Hubs interested in promoting team science and best practices when developing learning modules. Results contribute to what is known about researchers interest in learning about team science and the effectiveness of using online formats for delivery.

Advancing diversity, equity, and inclusion within clinical and translational science training programs: A qualitative content analysis of the training breakout session at the national CTSA program meeting.

Diversity, equity, and inclusion (DEI) in clinical and translational science (CTS) are paramount to driving innovation and increasing health equity. One important area for improving diversity is among trainees in CTS programs. This paper reports on findings from a special session at the November 2020 Clinical and Translational Science Award (CTSA) national program meeting that focused on advancing diversity and inclusion within CTS training programs. Using qualitative content analysis, we identified approaches brought forth to increase DEI in KL2 career development and other training programs aimed at early-stage CTS investigators, beyond the six strategies put forth to guide the breakout session (prioritizing representation, building partnerships, making it personal, designing program structure, improving through feedback, and winning endorsement). We used an inductive qualitative content analysis approach to identify themes from a transcript of the panel of KL2 program leaders centered on DEI in training programs. We identified four themes for advancing DEI within CTS training programs: 1) institutional buy-in; 2) proactive recruitment efforts; 3) an equitable application process; and 4) high-quality, diverse mentorship. Implementing these strategies in CTS and other training programs will be an important step for advancing DEI. However, processes need to be established to evaluate the implementation and effectiveness of these strategies through continuous quality improvement, a key component of the CTSA program. Training programs within the CTSA are well-positioned to be leaders in this critical effort to increase the diversity of the scientific workforce.

Impact of a Clinical and Translational Science Awards hub on faculty research grant productivity

Abstract Introduction: Applications for and receipt of external research grants are important indicators of scientific productivity, and ones that the Clinical and Translational Science Awards (CTSA) Program is intended to support. Methods: We investigate the association between the receipt of support services from one CTSA-supported hub and investigator productivity as measured by individual investigator grant submissions and grant awards at a Research I public university over an 8-year period. Negative binomial regression models are used to evaluate associations between individual grant productivity (in 2017, 2018, and 2019) and receipt of support services during the preceding 2 years. Results: Controlling for prior levels of productivity, service receipt is found to be predictive of both grants submitted and grants awarded to investigators in each model examined. Analyses also found some evidence of faculty rank and race/ethnic differences in the effects of Center for Clinical and Translational Science (CCTS) service use on subsequent grant productivity. Conclusions: Further work is needed to understand the relationship between clinical and translational services and other measures of productivity.

Educational initiative in an NCATS TL1 training program to address the impact of systemic racism on human health, biomedical research, and the translational scientist

The goal of clinical and translational science (CTS) is to fill gaps in medical knowledge toward improving human health. However, one of our most pressing challenges does not reside within the biological map we navigate to find sustainable cures but rather the moral compass to recognize and overcome racial and ethnic injustices that continue to influence our society and hinder diverse research rigor. The Georgetown-Howard Universities Center for Clinical and Translational Science includes an inter-institutional TL1-funded training program for predoctoral/postdoctoral trainees in Translational Biomedical Science (TBS). In the fall of 2020, the TBS program responded to the national social justice crisis by incorporating a curriculum focused on structural racism in biomedical research. Educational platforms, including movie reviews, Journal Clubs, and other workshops, were threaded throughout the curriculum by ensuring safe spaces to discuss racial and ethnic injustices and providing trainees with practical steps to recognize, approach, and respond to these harmful biases in the CTS. Workshops also focused on why individuals underrepresented in science are vital for addressing and closing gaps in CTS. Paring analysis using REDCap software de-identified participants after invitations were sent and collected in the system to maintain anonymity for pre- and post-analysis. The Likert scale evaluated respondents' understanding of diverse scientific circumstances. The pre/Fall and post/Spring surveys suggested this curriculum was successful at raising institutional awareness of racial and ethnic biases. Evaluating the effectiveness of our program with other training Clinical and Translational Science Awards (CTSA) consortiums will strengthen both the academic and professional TBS programs.