Barriers and facilitators to recruitment of underrepresented research participants: Perspectives of clinical research coordinators.

Background: Insufficient recruitment of groups underrepresented in medical research threatens the generalizability of research findings and compounds inequity in research and medicine. In the present study, we examined barriers and facilitators to recruitment of underrepresented research participants from the perspective of clinical research coordinators (CRCs). Methods: CRCs from one adult and one pediatric academic medical centers completed an online survey in April-May 2022. Survey topics included: participant language and translations, cultural competency training, incentives for research participation, study location, and participant research literacy. CRCs also reported their success in recruiting individuals from various backgrounds and completed an implicit bias measure. Results: Surveys were completed by 220 CRCs. CRCs indicated that recruitment is improved by having translated study materials, providing incentives to compensate participants, and reducing the number of in-person study visits. Most CRCs had completed some form of cultural competency training, but most also felt that the training either had no effect or made them feel less confident in approaching prospective participants from backgrounds different than their own. In general, CRCs reported having greater success in recruiting prospective participants from groups that are not underrepresented in research. Results of the implicit bias measure did not indicate that bias was associated with intentions to approach a prospective participant. Conclusions: CRCs identified several strategies to improve recruitment of underrepresented research participants, and CRC insights aligned with insights from research participants in previous work. Further research is needed to understand the impact of cultural competency training on recruitment of underrepresented research participants.

The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators' perceptions in Japan.

BACKGROUND: The shared decision-making model has been proposed as the ideal treatment decision-making process in medical encounters. However, the decision to participate in clinical trials rarely involves shared decision-making. In this study, we investigated the perceptions of Japanese clinical research coordinators who routinely support the informed consent process. METHODS: This study aimed to (1) identify clinical research coordinators' perceptions of the current status of shared decision-making implementation and its influencing factors, and (2) obtain suggestions to enhance the shared decision-making process in clinical trials. A cross-sectional survey was conducted using a web questionnaire based on the Theory of Planned behaviour. Invitations were sent to 1087 Japanese medical institutions, and responses from the participants were captured via the web. The shared decision-making process in clinical trials was defined according to the Shared Decision-Making Questionnaire for Doctors. The effect of the attitudes toward shared decision-making, clinical research coordinators' subjective norms towards its implementation, perceived barriers to autonomous decision-making, and the number of difficult steps in the shared decision-making process on the shared decision-making current status as the shared decision-making intention was assessed by multiple regression analysis. RESULTS: In total, 373 clinical research coordinators responded to the questionnaire. Many believed that they were already implementing shared decision-making. Attitudes toward shared decision-making (t = 3.400, p < .001), clinical research coordinators' subjective norms towards its implementation (t = 2.239, p = .026), perceived barriers to autonomous decision-making (t = 3.957, p < .001), and the number of difficult steps in the shared decision-making process (t = 3.317, p = .001) were found to significantly influence current status (Adjusted R2 = .123). However, results on perceived barriers to autonomous decision-making and the number of difficult steps in the shared decision-making process indicate a lack of knowledge of shared decision-making and decision-support skills among clinical research coordinators. CONCLUSIONS: Clinical research coordinators might positively perceive shared decision-making based on normative beliefs without sufficient knowledge of it. Therefore, providing appropriate training on shared decision-making to clinical research coordinators and increasing awareness among stakeholders could enable its improvement. TRIAL REGISTRATION: Not applicable.

Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial Patients.

PURPOSE: Clinical research coordinators (CRCs) play an important role in the protection of clinical trial participants and maintenance of ethical standards. However, limited data are available on the ethical cognition of CRCs. Understanding the knowledge, attitude, and practices (KAP) of CRCs toward ethics is essential to protect study participants and improve their compliance. METHODS: We conducted a descriptive, cross-sectional, quantitative study at 20 hospitals in Anhui province of China. A self-administered questionnaire was completed by 435 CRCs conducting clinical trials. RESULTS: The good knowledge, positive attitude, and good practice rates were 55.2%, 59.3%, and 79.5% respectively. Most CRCs (99.1%) were aware of the participants' rights. Only 127 (29.2%) and 140 (32.2%) CRCs were aware of measures to protect participants' rights and ethical guidelines regarding trials, respectively. In total, 59.6% of CRCs stated that ethical review might delay the start of a clinical trial. Marital status (odds ratio [OR] 0.47, 95% confidence interval [CI] 0.27-0.83), CRC work experience (OR 0.11, 95% CI 0.02-0.75), and educational background (OR 0.31, 95% CI 0.13-0.76) affected the knowledge of CRCs regarding ethics. CONCLUSIONS: Some deficiencies were observed in the ethical knowledge and behavior of CRCs. Interventions to improve the ethical training of CRCs regarding study participant protection, international guidelines, and the role of ethical committees are essential when conducting clinical trials. Validated instruments should be constructed to assess the effectiveness of ethical training and measure the KAP of CRCs toward ethics.

Incivility Is Associated with Burnout and Reduced Compassion Satisfaction: A Mixed-Method Study to Identify Causes of Burnout among Oncology Clinical Research Coordinators.

While oncology clinical research coordinators (CRCs) experience a combination of factors that are thought to put them at increased risk for burnout, very little research has been conducted to understand the risk factors associated with burnout among CRCs. We used a mixed-method approach, including self-report questionnaires to assess burnout and compassion satisfaction, as well as individual and interpersonal variables hypothesized to impact CRC well-being. We also conducted a focus group to gain a more nuanced understanding of coordinators' experiences around burnout, teamwork, resilience, and incivility. Coordinators reported relatively moderate levels of burnout and compassion satisfaction. Resilience, sleep dysfunction, stress, and incivility experienced from patients/family were significant predictors of burnout. Resilience and incivility from patients/family were significant predictors of compassion satisfaction. Themes that emerged from the focus group included that burnout is triggered by feeling overwhelmed from the workload, which is buffered by what was described as a supportive work culture based in teamwork. This study identified variables at the individual and interpersonal level that are associated with burnout and compassion satisfaction among oncology CRCs. Addressing these variables is of critical importance given that oncology CRCs and team-based coordinator care are vital to the success of clinical trials.

Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study.

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (α = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals' mastery of GCP content.

How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.

BACKGROUND: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. METHODS: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation. RESULTS: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). CONCLUSION: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

Perceived professional competence of clinical research coordinators.

INTRODUCTION: This study examined the perceived competence of Clinical Research Coordinators (CRCs) using several conceptual frameworks. Accurate self-assessment of one's professional competence is a critical component in the career navigation process and contributes to (a) identifying and securing professional development (training), (b) leveraging professional strengths, and (c) integrating self-knowledge into a comprehensive career plan. METHOD: A survey design gathered responses from a sample of 119 CRCs in a southeastern region of the USA Two conceptual frameworks were used to represent aspects of CRC professional competence: the eight Joint Task Force (JTF) competence domains, and perceptions of strengths and training needs from a list of 12 task categories. RESULTS: The JTF domain with the lowest competence level was Development and Regulations, while the highest was Communication. Perceived competence increased incrementally with years of experience. Top strengths involved direct patient interaction and data management. Tasks in need of training included project management and reporting issues. Variations in responses were based on years of experience as a CRC. CONCLUSION: Our results demonstrate an association between the self-reported strengths and training needs of CRCs and experience. This information can contribute to the self-directed career navigation of CRCs.

Clinical Research Coordinators' Attitude Toward Risk-Based Monitoring.

BACKGROUND: Clinical research coordinators (CRCs) are persons who collect, record, and maintain clinical trial data in accordance with the principles of Good Clinical Practice at investigators' sites. This study was conducted to examine attitudes of clinical research coordinators (CRCs) toward risk-based monitoring (RBM) prior to full-scale implementation of RBM in Korea. METHODS: The study subjects were 607 CRCs, and data were collected using a self-reported questionnaire. Collected data were analyzed by frequency, percentage, χ2 test and Fisher exact test. RESULTS: Among CRCs, 42.3% had heard of RBM and 44.6% were found to oppose its implementation. Those opposed believed that implementation of RBM would increase the workload of CRCs and CRAs' work support for CRCs. In addition, they showed many negative opinions such as poor accuracy of test data input and failure to increase the overall quality of clinical tests. In particular, such attitudes were more noticeable in CRCs with 5 or more years of experience. CONCLUSION: Before the implementation of RBM, it is necessary to come up with administrative measures such as education for practitioners and recruitment of human resources to help CRCs properly understand RBM.

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators.

BACKGROUND: The new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions. METHODS: We conducted a survey using self-reporting questionnaires in clinical research-related personnel to examine present status and the perspectives toward broader contribution of clinical research coordinators. The study participants were attendee of group discussion of a clinical research-related meeting in Shikoku area of Japan held in August 2017. RESULTS: Among 88 participants, 69 responded (response rate: 78.4%) and 68 respondents (98.6%) were engaged in support and management of clinical research. The main area of involvement was industry-initiated registration trials (48, 69.7%), and main roles of involvement were cooperators who plays roles under the guidance of investigators (41, 59.5%). When divided by occupation into clinical research coordinators (n = 41) and other clinical research-related personnel (n = 28), approximately half of the respondents in each group replied positively to wanting broader involvement of clinical research coordinators as a clinical research professional. CONCLUSION: The present study revealed that about half of the clinical research coordinators and other clinical research-related personnel view a broadening of involvement of clinical research coordinators in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help to expand and strengthen their contribution into the future. Whether greater involvement of clinical research coordinators in clinical research will help to ensure the reliability of investigator-initiated clinical research warrants further study.

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.

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.

Pharmacy Students' Knowledge and Attitude toward Registration Trials and Clinical Research: A Survey in a Japanese University Hospital.

Clinical research plays a fundamental role in establishing new treatments. Clinical research coordinators are considered essential in clinical research, and medical professionals such as pharmacists often take on this role. Pharmacy students can be considered future candidates for this task. We used questionnaires to survey the knowledge of and attitudes toward registration trials and clinical research of pharmacy students at Tokushima University Hospital. All pharmacy students (103) to whom questionnaires were sent responded. Almost all respondents were aware of registration trials and clinical research. More than 90% were aware of the existence of clinical research coordinators, and about half (48.6%) understood their role. In clinical research terminology, most respondents were aware of informed consent and related issues, but fewer than 20% were aware of more practical things. In total, 29.1% and 40.8% of the respondents were willing to carry out and coordinate research. These findings suggest that pharmacy students have basic knowledge of clinical research and that many students are willing to carry out and coordinate clinical research. More practical exposure to clinical research may help to strengthen their future contribution. Further studies may help to determine how to provide education on registration trials and clinical research to pharmacy students.

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators.

INTRODUCTION: Randomized controlled trials (RCTs) are the gold standard within evidence-based research. Low participant accrual rates, especially of underrepresented groups (e.g., racial-ethnic minorities), may jeopardize clinical studies' viability and strength of findings. Research has begun to unweave clinical trial mechanics, including the roles of clinical research coordinators, to improve trial participation rates. METHODS: Two semi-structured focus groups were conducted with a purposive sample of 29 clinical research coordinators (CRCs) at consecutive international stroke conferences in 2013 and 2014 to gain in-depth understanding of coordinator-level barriers to racial-ethnic minority recruitment and retention into neurological trials. Coded transcripts were used to create themes to define concepts, identify associations, summarize findings, and posit explanations. RESULTS: Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified. Potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs. CONCLUSION: Patient level barriers to clinical trial recruitment are well documented. Less is known about barriers facing CRCs. Further identification of how and when barriers manifest and the effectiveness of strategies to improve CRCs recruitment efforts is warranted.

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.

Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials.

BACKGROUND: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. PURPOSE: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. METHOD: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. DISCUSSION: Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. CONCLUSIONS: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.

Current Tasks and Appropriate Tasks of Clinical Research Coordinators in Korea

BACKGROUND: This study was aimed to investigate current tasks done by clinical research coordinators (CRCs) and appropriate tasks of CRCs perceived by investigators, and to classify tasks for CRCs into four categories such as standard, recommended, considered and limited tasks. METHODS: The participants were 533 CRCs and 114 investigators who have employed CRCs. Data were collected with self-administrated questionnaire including general characteristics and 32 possible tasks of CRCs from August to November, 2010. Data was analyzed using SPSS win (version 18.0) with descriptive statistics. RESULTS: There were 24 tasks being done by more than half of CRCs, and 15 tasks by more than 75 % of CRCs among 32 possible tasks. The most common task done by CRCs was 'collecting data based on the protocol' and the next was 'scheduling of subjects'. More than half of investigators perceived that all tasks but budgeting appropriate to be done by CRCs, and 18 tasks by more than 75 % of investigators. 13 tasks were classified as standard tasks, 14 as recommended tasks, four as considered tasks, and one as limited task. CONCLUSION: Standard and recommended tasks for CRCs in Korea have been drawn based on the current tasks done by CRCs and appropriate tasks of CRCs perceived by investigators. It is recommended that investigators utilize this results when they delegate tasks to CRCs and appropriate educational programs could be provided so that CRCs perform standard and recommended tasks proficiently.