DEI co-mentoring circles for clinical research professionals: A pilot project and toolkit.

Background: There have been a number of federal policies and guidance's impacting diversity, equity, inclusion, and accessibility (DEI) in clinical research. While these are needed, they have not diminished the gaps related to clinical trial recruitment, research professional's capacity for cultural competence, and clinical research professional role development. Mentoring and co-mentoring circles have traditionally been used in Medicine, but until now had not been used for workforce development of clinical research professionals (CRPs). Materials/Methods: We designed a six-session, monthly co-mentoring circle to take place at two academic medical centers to pilot an interinstitutional co-mentoring circle centered on storytelling videos of Black Voices in Clinical Research. This provided a DEI framework for discussions on role experiences, cultural competence, and role progression. Results: Seven CRPs completed the DRC pilot. The participants positively evaluated the experience and made recommendations for future iterations. Discussion: Co-mentoring circles can be useful tools to connect CRPs across complex research medical centers and provide support that may have a positive impact on role satisfaction and retention. Conclusion: This framework for developing co-mentoring circles can serve as a toolkit for future CRP co-mentoring circles within and across institutions for workforce development. The Black Voices in Clinical Research storytelling videos provide a rich foundation for future discussion on DEI issues for CRPs and collaborating with participants.

Academic medical center clinical research professional workforce: Part 2 - Issues in staff onboarding and professional development.

Background: Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway. Materials/Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers. Results: Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway. Conclusion: Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

Issues for recruitment and retention of clinical research professionals at academic medical centers: Part 1 - collaborative conversations Un-Meeting findings.

Background: Identification of evidence-based factors related to status of the clinical research professional (CRP) workforce at academic medical centers (AMCs) will provide context for National Center for Advancing Translational Science (NCATS) policy considerations and guidance. The objective of this study is to explore barriers and opportunities related to the recruitment and retention of the CRP workforce. Materials and Methods: Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore barriers and recommendations for improving AMC CRP recruitment, retention and diversity. Results: While certain institutions have established competency-based frameworks for job descriptions, standardization remains generally lacking across CTSAs. AMCs report substantial increases in unfilled CRP positions leading to operational instability. Data confirmed an urgent need for closing gaps in CRP workforce at AMCs, especially for attracting, training, retaining, and diversifying qualified personnel. Improved collaboration with human resource departments, engagement with principal investigators, and overcoming both organizational and resource challenges were suggested strategies, as well as development of outreach to universities, community colleges, and high schools raising awareness of CRP career pathways. Discussion: Based on input from 130 CRP leaders at 35 CTSAs, four National Institute of General Medical Sciences' Institutional Development Award (IDeA) program sites, along with industry and government representatives, we identified several barriers to successful recruitment and retention of a highly trained and diverse CRP workforce. Results, including securing institutional support, champions, standardizing and adopting proven national models, improving local institutional policies to facilitate CRP hiring and job progression point to potential solutions.

Communication in clinical research: Uncertainty, stress, and emotional labor.

This exploratory study investigated perceptions of competent vs. contentious communication in the workplace as experienced by Clinical Research Professionals (CRPs) managing or coordinating clinical research. Qualitative data collected from a 90-min focus group interview were thematically analyzed using open and axial coding and constant comparison. Findings suggest CRPs associate contentious communication with uncertainty, stress, and emotional labor. Further, although many participants regularly utilize effective conflict and emotion management strategies, they lack confidence in both knowledge and efficacy of competent communication, stress management, and emotion management skills. Conclusions support revising "Wheel of Competencies" figure representing the Joint Task Force for Clinical Trial Competency framework. Study limitations and suggestions for future research and educational training are discussed.

The Black Voices in Research curriculum to promote diversity and inclusive excellence in biomedical research.

Underrepresentation of Black biomedical researchers demonstrates continued racial inequity and lack of diversity in the field. The Black Voices in Research curriculum was designed to provide effective instructional materials that showcase inclusive excellence, facilitate the dialog about diversity and inclusion in biomedical research, enhance critical thinking and reflection, integrate diverse visions and worldviews, and ignite action. Instructional materials consist of short videos and discussion prompts featuring Black biomedical research faculty and professionals. Pilot evaluation of instructional content showed that individual stories promoted information relevance, increased knowledge, and created behavioral intention to promote diversity and inclusive excellence in biomedical research.

Ensuring Representativeness in Competencies for Research Coordinators.

Providing educational programs designed to promote clinical research coordinators' (CRCs') implementation of competency skills is essential to workforce development; however, little is known about how programs address CRCs' needs. The purpose of this study was to assess CRCs' experiences in a six-month course. Using focus group methods, six participants revealed how the training assisted them in daily work. The findings supported previous study results, and led to the identification of two competencies which are missing from the existing Joint Task Force for Clinical Trial Competency framework domains of "Communication and Teamwork" and "Leadership and Professionalism." The authors explain why these competencies are important for coordinators. The authors also discuss the instrumentality of qualitative research to ensure that competency domains reflect the needs of those for whom they are developed.

Advancing the Practice of CRCs: Why Professional Development Matters.

Clinical research coordinators (CRCs) assume critical responsibilities central to the success of the research team. The complexity of their role requires essential professional qualifications. One barrier to professionalization, however, has been the inconsistent, or absent, competency-based training. This study explored participants' perceptions of training experiences designed to prepare them for the national certification exam. Focus group methodology was used to document their experiences. The findings showed that sustainable mentoring relationships developed, participant confidence levels increased, and anxiety about performance capacity diminished. Cognitive reframing of the work environment and CRC roles was facilitated by training that fostered sharing and social reinforcement of professional and personal identities. Findings from this study suggest that access to meaningful training and quality instruction supports the professionalization of CRCs.

Best Practices in Social and Behavioral Research: A multisite pilot evaluation of the good clinical practice online training course.

INTRODUCTION: The Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course. METHODS: Participants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted. RESULTS: Participants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later. DISCUSSION: The course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.

Clinical research coordinators' instructional preferences for competency content delivery.

INTRODUCTION: A lack of standardized clinical research coordinator (CRC) training programs requires determining appropriate approaches for content delivery. The purpose of this study was to assess CRCs preferred training delivery methods related to the 8 designated Joint Task Force Clinical Trial Competency domains. METHODS: Repeated measures analysis of variance and split-plot analysis of variance were adopted to compare the group means among 5 training delivery methods by 8 competency content domains and to examine whether demographic variables caused different preference patterns on the training delivery methods. RESULTS: Participants reported a preference for online video; mentoring/coaching was the least preferred. Significant training delivery method preferences were reported for 3 content domains: participant safety considerations, medicines development and regulation, and clinical trials operations. DISCUSSION: Observed statistical differences in the training delivery methods by the content domains provides guidance for program development. Ensuring that standardized educational training is aligned with the needs of adult learners may help ensure that CRCs are appropriately prepared for the workforce.

Training Impact on Novice and Experienced Research Coordinators.

Competency-based training and professional development is critical to the clinical research enterprise. Understanding research coordinators' perspectives is important for establishing a common core curriculum. The purpose of this study was to describe participants' perspectives regarding the impact of online and classroom training sessions. 27 participants among three institutions, completed a two-day classroom training session. 10 novice and seven experienced research coordinators participated in focus group interviews. Grounded theory revealed similarities in novice and experienced coordinator themes including Identifying Preferences for Instruction and Changing Self Perceptions. Differences, seen in experienced participants, focused on personal change, in the theme of Re-Assessing Skills. Infrastructure and cultural issues were evident in their theme, Promoting Leadership and Advocacy. Novice participants recommended ways to improve training via their theme of Making Programmatic Improvements. Participants reported a clear preference for classroom learning. Training played an influential role in changing participants' self-perceptions by validating their experiences. The findings provided guidance for developing a standardized curriculum. Training must be carefully tailored to the needs of participants while considering audience needs based on work experience, how technology can be used and offering content that is most urgently needed.

Accrual and recruitment practices at Clinical and Translational Science Award (CTSA) institutions: a call for expectations, expertise, and evaluation.

PURPOSE: To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability. METHOD: The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. RESULTS: Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%-91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents' IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. CONCLUSIONS: Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.

A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial.

CONTEXT: Despite evidence of efficacy of antihypertensive agents in treating hypertensive patients, safety and efficacy of antihypertensive agents for coronary artery disease (CAD) have been discerned only from subgroup analyses in large trials. OBJECTIVE: To compare mortality and morbidity outcomes in patients with hypertension and CAD treated with a calcium antagonist strategy (CAS) or a non-calcium antagonist strategy (NCAS). DESIGN, SETTING, AND PARTICIPANTS: Randomized, open label, blinded end point study of 22 576 hypertensive CAD patients aged 50 years or older, which was conducted September 1997 to February 2003 at 862 sites in 14 countries. INTERVENTIONS: Patients were randomly assigned to either CAS (verapamil sustained release) or NCAS (atenolol). Strategies specified dose and additional drug regimens. Trandolapril and/or hydrochlorothiazide was administered to achieve blood pressure goals according to guidelines from the sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) of less than 140 mm Hg (systolic) and less than 90 mm Hg (diastolic); and less than 130 mm Hg (systolic) and less than 85 mm Hg (diastolic) if diabetes or renal impairment was present. Trandolapril was also recommended for patients with heart failure, diabetes, or renal impairment. MAIN OUTCOME MEASURES: Primary: first occurrence of death (all cause), nonfatal myocardial infarction, or nonfatal stroke; other: cardiovascular death, angina, adverse experiences, hospitalizations, and blood pressure control at 24 months. RESULTS: At 24 months, in the CAS group, 6391 patients (81.5%) were taking verapamil sustained release; 4934 (62.9%) were taking trandolapril; and 3430 (43.7%) were taking hydrochlorothiazide. In the NCAS group, 6083 patients (77.5%) were taking atenolol; 4733 (60.3%) were taking hydrochlorothiazide; and 4113 (52.4%) were taking trandolapril. After a follow-up of 61 835 patient-years (mean, 2.7 years per patient), 2269 patients had a primary outcome event with no statistically significant difference between treatment strategies (9.93% in CAS and 10.17% in NCAS; relative risk [RR], 0.98; 95% confidence interval [CI], 0.90-1.06). Two-year blood pressure control was similar between groups. The JNC VI blood pressure goals were achieved by 65.0% (systolic) and 88.5% (diastolic) of CAS and 64.0% (systolic) and 88.1% (diastolic) of NCAS patients. A total of 71.7% of CAS and 70.7% of NCAS patients achieved a systolic blood pressure of less than 140 mm Hg and diastolic blood pressure of less than 90 mm Hg. CONCLUSION: The verapamil-trandolapril-based strategy was as clinically effective as the atenolol-hydrochlorothiazide-based strategy in hypertensive CAD patients.