This article presents a landscape assessment of the findings from the 2021 Clinical and Translational Science Award (CTSA) Evaluators Survey. This survey was the most recent iteration of a well established, national, peer-led systematic snapshot of the CTSA evaluators, their skillsets, listed evaluation resources, preferred methods, and identified best practices. Three questions guided our study: who are the CTSA evaluators, what competencies do they share and how is their work used within hubs. We describe our survey process (logistics of development, deployment, and differences in historical context with prior instruments); and present its main findings. We provide specific recommendations for evaluation practice in two main categories (National vs Group-level) including, among others, the need for a national, strategic plan for evaluation as well as enhanced mentoring and training of the next generation of evaluators. Although based on the challenges and opportunities currently within the CTSA Consortium, takeaways from this study constitute important lessons with potential for application in other large evaluation consortia. To our knowledge, this is the first time 2021 survey findings are disseminated widely, to increase transparency of the CTSA evaluators' work and to motivate conversations within hub and beyond, as to how best to leverage existent evaluative capacity.

Clinical trials are essential in the translation of biomedical discoveries to new clinical interventions and therapeutics. Successful multisite clinical trials require qualified site investigators with an understanding of the full spectrum of processes and requirements from trial identification through closeout. New site investigators may be deterred by competing demands on their time, the complexity of administrative and regulatory processes for trial initiation and conduct, and limited access to experienced mentor networks. We established a Clinical Trialist Training Program (CTTP) and complimentary Clinical Trials Bootcamp at our institution to address these barriers and increase the number of local site investigators enabled to lead successful clinical trials. An initial cohort of four CTTP scholars received salary support with protected time, didactic training, assistance with study identification and start-up navigation, and quarterly progress meetings. By the end of the 12-month program, this initial cohort identified 33 new trials, utilized feasibility assessments, and reported being on target to sustain their protected time from new clinical trials. Bootcamp attendees demonstrated increased knowledge of resources, offices, and processes associated with clinical trial conduct. Our results support providing compensated protected time, training, and access to experienced clinical research professionals to enable clinicians to become successful site investigators.

Low-accruing clinical trials delay translation of research breakthroughs into the clinic, expose participants to risk without providing meaningful clinical insight, increase the cost of therapies, and waste limited resources. By tracking patient accrual, Clinical and Translational Science Awards hubs can identify at-risk studies and provide them the support needed to reach recruitment goals and maintain financial solvency. However, tracking accrual has proved challenging because relevant patient- and protocol-level data often reside in siloed systems. To address this fragmentation, in September 2020 the South Carolina Clinical and Translational Research Institute, with an academic home at the Medical University of South Carolina, implemented a clinical trial management system (CTMS), with its access to patient-level data, and incorporated it into its Research Integrated Network of Systems (RINS), which links study-level data across disparate systems relevant to clinical research. Within the first year of CTMS implementation, 324 protocols were funneled through CTMS/RINS, with more than 2600 participants enrolled. Integrated data from CTMS/RINS have enabled near-real-time assessment of patient accrual and accelerated reimbursement from industry sponsors. For institutions with bioinformatics or programming capacity, the CTMS/RINS integration provides a powerful model for tracking and improving clinical trial efficiency, compliance, and cost-effectiveness.

Developing the translational research workforce is a goal established by the National Center for Advancing Translational Science for its network of Clinical and Translational Science Award Program hubs. We surveyed faculty and research staff at our institution about their needs and preferences, utilization of existing trainings, and barriers and facilitators to research training. A total of 545 (21.9%) faculty and staff responded to the survey and rated grant development, research project development, and professional development among their top areas for further training. Faculty prioritized statistical methods and dissemination and implementation, while staff prioritized research compliance and research administration. Faculty (73.9%; n = 119) and staff (87.3%; n = 165) reported that additional training would give them more confidence in completing their job responsibilities. Time and lack of awareness were the most common barriers to training. Our results indicate the value of training across a range of topics with unique needs for faculty and staff. This pre-COVID survey identified time, awareness, and access to training opportunities as key barriers for faculty and staff. The shift to remote work spurred by the pandemic has further heightened the need for effective and readily accessible online trainings to enable continuous development of the clinical and translational research workforce.

ABSTRACT IMPACT: Investigators in clinical and translational research will be better supported by CTSAs that reduce barriers to the efficient and effective utilization of their program services. OBJECTIVES/GOALS: Evidence from three CTSAs show that investigators do not take advantage of all program services provided. This session will explore the patterns and sources of underutilization by sharing preliminary results from investigators and program managers. METHODS/STUDY POPULATION: Interviews with investigators at all three CTSA sites were conducted in Spring 2020. Investigators who had only used one program service and those who had used multiple program services across a span of three-years (2016 to 2018) were included in the sample. Investigators who had only used REDCap, were excluded. Interviews numbered about six interviews per site. Content analysis helped identify emerging themes and patterns. A survey with program managers at the three CTSA sites will be deployed in January 2021. Program managers across all programs will be included in the sample. Basic descriptive analysis will be used to analyze the data. RESULTS/ANTICIPATED RESULTS: Interviews with investigators at all sites illuminated ways different investigators use, learned about and leveraged services, as well as the barriers they encountered to using cross-program services. Investigators also provided thoughts on ways to address lack of program service use. Survey results are expected to clarify program managers’ knowledge of other program services in their CTSA, programs’ referral processes, and the barriers program managers face when recommending other services to users. DISCUSSION/SIGNIFICANCE OF FINDINGS: When investigators do not take full advantage of all program services provided, investigators are put at risk of having longer, less successful projects. Knowing the sources of underutilization can help curb this trend and effectively address investigator needs throughout the research process.

The mission of the National Center for Advancing Translational Science (NCATS) is to speed the development of drugs from discovery to approval to dissemination and implementation. The Medical University of South Carolina and the South Carolina Clinical and Translational Research Institute host a NCATS funded predoctoral T32 training grant (TL1) with a focus on translational research. Doctoral (PhD) trainees working at the bench usually have limited opportunity for clinical interactions to gain a clinical perspective on the diseases that are the focus of their dissertation research. To provide TL1 trainees with an opportunity to see how their research could be translated into improved patient care, we developed a mentored clinical exposure experience named the Translational Sciences Clinic. Trainees spend one-half day a week in a clinic related to their basic science research for one semester interacting with patients and clinical mentors and discuss the most recent literature related to the patient’s clinical problem with their clinical mentor. Trainees deemed the rotation to be one of the most rewarding experiences that they had as a part of their predoctoral training. Participating clinical mentors were also very enthusiastic and agreed that they would be willing to mentor similar trainees again.

The mission of the National Center for Advancing Translational Science (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.1 NCATS funded a predoctoral TL1 training grant at our institution. We developed a novel team-based Translational Journal Club utilizing three-member teams to find a basic science paper and two clinical study papers that covered a single therapeutic, either a pivotal study or a dissemination and implementation study; one member of the team presented a paper on the above topics in successive weeks. In addition, the trainees attended lectures on: how to design a pivotal clinical trial, dissemination and implementation, and drug development from a basic science discovery through its approval. From these presentations, the trainees appreciated the T0 to T3/4 continuum and its challenges. They also attended sessions on how to present scientific concepts, making them better communicators. The trainees found the Translational Journal club to be very rewarding, illuminating, and providing a much better understanding of the translational research processes required to develop new therapies.