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Introduction: Clinical research requires a competent workforce of clinical research professionals (CRPs) who are well-trained to perform varied and complex tasks within their roles. The Joint Task Force for Clinical Trial Competency (JTF) framework established essential domains for conducting high-quality clinical research that can guide professional development of CRPs. The Research Professionals Network (RPN) Workshops were established in 2017 to focus on developing ongoing inter-institutional, peer-led, JTF-centric continuing education for CRPs. Four institutions and their affiliates are part of the collaboration. Methods: Workshop participant survey data and other metrics were collected over four academic years. Both quantitative and qualitative analyses were performed to assess participant experience and identify relevant themes. Results: Participants demonstrated overall high satisfaction with the workshops and significantly value the interpersonal, inter-institutional collaboration made possible through the workshops. Conclusions: These inter-institutional RPN Workshops have evolved into a Community of Practice, which can be expanded into future opportunities.
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Introduction: Implementation of research findings in clinical practice often is not realized or only partially achieved, and if so, with a significant delay. Learning health systems (LHSs) hold promise to overcome this problem by embedding clinical research and evidence-based best practices into care delivery, enabling innovation and continuous improvement. Implementing an LHS is a complex process that requires participation and resources of a wide range of stakeholders, including healthcare leaders, clinical providers, patients and families, payers, and researchers. Engaging these stakeholders requires communicating clear, tangible value propositions. Existing models identify broad categories of benefits but do not explicate the full range of benefits or ways they can manifest in different organizations. Methods: To develop such a framework, a working group with representatives from six Clinical and Translational Science Award (CTSA) hubs reviewed existing literature on LHS characteristics, models, and goals; solicited expert input; and applied the framework to their local LHS experiences. Results: The Framework of LHS Benefits includes six categories of benefits (quality, safety, equity, patient satisfaction, reputation, and value) relevant for a range of stakeholders and defines key concepts within each benefit. Applying the framework to five LHS case examples indicated preliminary face validity across varied LHS approaches and revealed three dimensions in which the framework is relevant: defining goals of individual LHS projects, facilitating collaboration based on shared values, and establishing guiding tenets of an LHS program or mission. Conclusion: The framework can be used to communicate the value of an LHS to different stakeholders across varied contexts and purposes, and to identify future organizational priorities. Further validation will contribute to the framework's evolution and support its potential to inform the development of tools to evaluate LHS impact.
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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.
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Clinical Research Professionals (CRPs) are essential members of the Clinical and Translational Research Workforce. Many academic medical institutions struggle to recruit and retain these vital team members. One strategy to increase job satisfaction and promote the retention of CRPs is through educational initiatives that provide training and professional development. The South Carolina Clinical and Translational Research (SCTR) Institute Workforce Development (WD) team at the Medical University of South Carolina (MUSC) developed several trainings as part of our larger educational portfolio for CRPs. In 2022 WD implemented a digital badge micro-credential for SCTR's Core Clinical Research Training (CCRT) course in collaboration with institution-wide education and technology offices. Beginning in January 2023, individuals were able to earn the CCRT Certified Digital Badge upon successful completion of the CCRT course.
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Background/Objective: The Clinical and Translational Science Award (CTSA) program aims to enhance the quality, efficiency, and impact of translation from discovery to interventions that improve human health. CTSA program hubs at medical research institutions across the United States develop and test innovative tools, methods, and processes, offering core resources and training for the clinical and translational research (CTR) workforce. Hubs have developed services across different domains, such as informatics and pilot studies, to provide ad hoc expertise and staffing for local research teams. Although these services can provide efficient, cost-effective ways to cover skills gaps and implement rigorous studies, three CTSAs of varying size found the majority of investigators were single domain service users, likely missing opportunities to further enhance their work. Methods: Through interviews with CTSA service users and a survey of CTSA service managers, this exploratory study aims to identify barriers to using services from multiple modules and solutions to overcome those barriers. Results: Barriers include challenges in finding information about services, unclear or unknown user needs, and users' lack of funding to engage in services. More issues were identified for the largest CTSA. Conclusions: Although this study represents a small subset of CTSA hubs, we anticipate that our findings and proposed solutions will be relevant to the broader CTSA community. This study provides foundational information can use in their own efforts to increase service utilization and methods that can be used for more comprehensive studies that focus on explaining the relationship between CTSA features and rates of single versus cross-module service use.
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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.
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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.
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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.
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BACKGROUND: There is discontent and turnover among faculty at US academic health centers because of the challenges in balancing clinical, research, teaching, and work-life responsibilities in the current healthcare environment. One potential strategy to improve faculty satisfaction and limit turnover is through faculty mentoring programs. METHODS: A Mentor Leadership Council was formed to design and implement an institution-wide faculty mentoring program across all colleges at an academic health center. The authors conducted an experimental study of the impact of the mentoring program using pre-intervention (2011) and 6-year (2017) post-intervention faculty surveys that measured the long-term effectiveness of the program. RESULTS: The percent of faculty who responded to the surveys was 45.9% (656/1428) in 2011 and 40.2% (706/1756) in 2017. For faculty below the rank of full professor, percent of faculty with a mentor (45.3% vs. 67.1%, P < 0.001), familiarity with promotion criteria (81.7% vs. 90.0%, P = 0.001), and satisfaction with department's support of career (75.6% vs. 84.7%, P = 0.002) improved. The percent of full professors serving as mentors also increased from 50.3% in 2011 to 68.0% in 2017 (P = 0.002). However, the percent of non-retiring faculty considering leaving the institution over the next 2 years increased from 18.8% in 2011 to 24.3% in 2017 (P = 0.02). CONCLUSIONS: Implementation of an institution-wide faculty mentoring program significantly improved metrics of career development and faculty satisfaction but was not associated with a reduction in the percent of faculty considering leaving the institution. This suggests the need for additional efforts to identify and limit factors driving faculty turnover.
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The prevalence of child sexual abuse demands innovative approaches to prevent further victimization. The online environment provides new opportunities to expand existing child sexual abuse prevention trainings that target adult gatekeepers and allow for large scale interventions that are fiscally viable. This article discusses the benefits and limitations of conducting online organizational trainings from the perspective of participants, including what participants found effective, what challenges were most commonly encountered, and trainee perspectives of the program's overall impact. The final section provides recommendations and lessons learned for practitioners and researchers who hope to utilize and assess online prevention trainings in the future.