Introduction
Clinical trials are widely viewed as the “gold standard” since they are required to prospectively evaluate the risks and benefits of a drug, device, behavioral intervention, or other forms of treatment [1]. Over the years, there has been an increase in clinical trials conducted worldwide [2]. With the increase in the number of clinical trials that are developed and implemented, there is a commensurate demand for a workforce that can support these studies [Reference Fordyce3–Reference Thomas, Wilson and Jester5]. Conducting a clinical trial requires a team who collectively are familiar with regulatory requirements, reporting efficacy and safety measures, ethical considerations, data management, and analysis considerations [Reference Calvin-Naylor6]. There has been an increasing effort to establish and implement training requirements by several clinical research organizations [Reference Sonstein7, Reference Sonstein8]. For studies conducted in the USA under the auspices of the federal government, clinical trial professionals are required, at a minimum, to maintain certification of training in human subjects’ research protections and good clinical practices (GCPs).
The Joint Task Force on Clinical Trial Competencies (JTF-CCT) established a core competency framework (CCF) to assess individuals’ role-relevance and self-competency for clinical research-related domains comprised of essential skills. The AIDS Malignancy Consortium (AMC) adopted the JTF-CCF to shape and enhance the professional development of their clinical trial workforce and to establish an online training program. The AMC was established in 1995 to prevent and treat cancer in HIV-infected persons by conducting clinical trials domestically and internationally in Sub-Saharan Africa (SSA) and in Latin America (LATAM). As the HIV epidemic has shifted to the developing world, the AMC has expanded its clinical trial activities to SSA in 2010 and to LATAM in 2018. This paper presents the results of the training needs assessment survey using the JTF-CCF survey to assess clinical investigators (CIs). The aim of this paper is to compare the scores for role-relevance and self-competence in order to identify where the greatest training needs are among the AMC CIs.
Methods
Survey and Study Design
The JTF-CCF assesses clinical professionals’ role-relevance and self-competency for skills falling under the following domains: (1) Scientific Concepts and Research Design, (2) Ethical and Participant Safety Considerations, (3) Medicines Development and Regulation, (4) Clinical Trials Operations, (5) Study and Site Management, (6) Data Management and Informatics, (7) Leadership and Professionalism, and (8) Communication and Teamwork. As advice is sought from community representatives to facilitate participant recruitment and retention, an additional domain was added to assess community engagement [9, 10]. The survey has been adapted by the Clinical and Translational Science Centers and customized to be administered to CIs, study coordinators, and data managers. The Hennessy–Hicks training needs analysis [Reference Hennessy and Hicks11] was followed to identify training needs and to prioritize training for AMC CIs. The role-relevance rating assesses how important a task is to the respondent’s job, whereas the self-competence rating measures how well a task is currently performed. The bigger the difference between the relevance and the competence scores, the greater the training need.
The AMC Training Needs Assessment was administered through the online SurveyMonkey™ platform. It was launched on September 14, 2018 for sites in SSA and on September 21, 2018 for the sites in LATAM; both surveys were closed on October 19, 2018. The assessment was translated from English to Spanish and Portuguese and it included two demographic questions, AMC site name and country, and 52 items related to research activities (refer to Supplementary Material). AMC CIs were asked to rate their role-relevance and competence within a domain using a five-point scale (0–4). The respective anchor question and the response options are shown in Table 1.
Self-perceived role-relevance and self-competence response options
Data Analysis
The self-competence level and role-relevance scores were averaged across skills within a given domain and graphed. The proportion of respondents who considered a skill relevant to their role was estimated as the proportion whose responses were 3 or 4. Similarly, the proportion of respondents who considered themselves competent with respect to a skill was estimated as the proportion whose responses were 3 or 4. Within each domain, the mean proportions of investigators who rated the skill as relevant to their role in conducting clinical trials and who considered themselves competent were calculated. Consistent with Sonstein et al. [Reference Sonstein8], in the present study, an average score of 60% or more implies “more competent” or “more relevant,” and a mean value of <60% implied “less competent” or “less relevant.” To determine the AMC training needs and the course development priorities, the mean self-competence score on the original 0–4 scale was subtracted from the mean role-relevance score [Reference Hennessy and Hicks11]. The data were analyzed using SAS (version 9.4).
Results
Investigators from 11 AMC sites were invited to participate; 8 sites were in SSA countries and 4 in countries in LATAM (data not shown). A total of 40 AMC CIs were invited to participate in the training needs assessment; of those, 35 submitted their responses for an 87.5% response rate. There were 13 CIs from LATAM countries and 22 from SSA countries (Table 2).
AIDS Malignancy Consortium (AMC) clinical investigators (CIs) by country (n = 35)
Figure 1 shows the mean domain score for relevance and competence as self-rated by CIs. CIs perceived themselves as highly competent in their knowledge of factors related to ethics and participant considerations. The data management and informatics and the community engagement domains had lower scores for competency domains. The results of the study showed that the greatest difference between the role-relevance and competence ratings were in the following domains: study and site management (difference of 0.7), leadership and professionalism (difference of 0.7), communication and teamwork (difference of 0.6), community engagement (difference of 0.6), and scientific concept and research design (difference of 0.5).
Domain means for relevance to role and competency. Scores for individual items (skills) were averaged within each domain. GCP, good clinical practices.
Perceptions of Competence and Relevance
Table 3 presents the average percentage of CIs who rated their skills high (score of 3 or 4) within each research domain for competence and relevance. The ethical and participant safety considerations had the highest mean role-relevance and self-competence percentages with 93.3% and 86.6%, respectively. The perceived role-relevance was high in the clinical trials operations and GCPs domain with a mean of 87%, followed by leadership and professionalism (87.5%). The only skill with less than 60% on the role-relevance scale was to summarize the process of electronic data capture and the importance of information technology in data collection, capture and management with 50% rating this skill high.
Clinical research domains among AIDS Malignancy Consortium (AMC) clinical investigators (CIs)
The domains with competency levels of 60% or less were medication development and regulation (59.3%), study and site management (59.3%), data management and informatics (46.6%), and community engagement (44.2%). These domains also showed a low role-relevance score on all their respective skills. In the scientific concept and design domain, investigators demonstrated greater ability to evaluate clinical trial designs or results (82.9%), but less confidence in their ability to design a clinical trial that operationalizes a testable hypothesis (51.4%).
In the clinical trials and GCPs domain, CIs expressed a high competence in their ability to review, assess, and report adverse events (80%), but felt less able to describe the appropriate control, storage, and dispensing of investigational products (57.1%) and host a clinical trial audit and respond to audit findings (51.4%). With respect to the study and site management domain, investigators’ competence was high for feasibility evaluation for trials and for managing recruitment and study progress (73.5%), but less confident in their abilities to manage resources and legal and regulatory responsibilities (50%).
Discussion
This paper aimed to assess role-relevance and self-perceived competence across the JTF-CC domains and identify where the greatest training needs are among the AMC CIs. As recommended by Kilic and collaborators [Reference Kilic12], training needs should be identified before the development of training programs. The goal of the AMC Training Program (ATP) is to improve and enhance clinical staff sites’ performance, while at the same time standardizing the process and consistency in the delivery of training. The results of the training needs assessment show that AMC CIs rated themselves as competent in their ability to review clinical trial design and results but were less confident in their ability to design a study. The JTF-CCT administered a survey similar to the one we used in this study among a multinational group of clinical research professionals that included investigators and clinical research associates or coordinators [Reference Sonstein8]. The findings from the JTF-CCT showed were consistent with our results, in which respondents indicated being competent, with a mean value of 60% or higher, in the ethical and participant safety considerations and the clinical trials operations. Within the scientific concept and research design domain, AMC CIs rated the design of a clinical trial that operationalizes a testable hypothesis as another competency where additional training was indicated. This finding was not consistent with the work of Barratt and Fulop [Reference Barratt and Fulop13] among allied health professionals, managers, and nurses, who indicated that designing research studies as one of the least important domains. Our data also show that CIs considered that they are competent in the medications and regulations domain and training in this area might not be a priority. Imamura et al. [Reference Imamura14] reported that medications and regulation were among the lowest competencies in regard to relevance and self-competence. Only 28% found this domain to be significant to their position and 24% felt competent in this domain.
AMC CIs rated the data management and informatics domain low for most of the skills or competencies for that domain, suggesting that training in this area could be considered given the low competency. However, the role-relevance was also rated low. This may be attributable for CI reliance on informatics professionals to design and operationalize data collection and handling for a study but may also be attributable to lack of awareness or misconception of data-related tasks as clerical in nature. This was not explored within the survey. Our findings conflict with the results of a training needs assessment survey of faculty members and students of the three minority medical institutions that make up the Puerto Rico Clinical Translational Research Consortium (PRCTRC); faculty members ranked statistical and informatics as one of the high priority areas for training based on high relevance and low competency [Reference Estapé-Garrastazu15].
The community engagement domain is new to our survey, but the findings suggest that this is an area for training for our investigators. It is likely that enhancing skills in this area may need to be tailored to a specific geographic region or clinic and reflect cultural norms. The need for development in the community engagement domain reflects the fact that this area has not historically been covered in education in clinical trials and has not been considered one of the core competencies [Reference Sonstein7, Reference Sonstein8]. Increasing familiarity and competency in this domain as community engagement has been shown to be useful in the design and implementation of cancer clinical trials [Reference Barger16] and enhancing the participation of underrepresented minorities [Reference Caren17, Reference Brooks18].
In this study, the leadership and professionalism competence levels were lower than those reported by Sonstein [Reference Sonstein8]. This may reflect a difference in the experience level of those holding leadership positions in clinical trials between the two studies. Most of the AMC investigators are relatively recent additions to the multicenter clinical trial network and many are beginning to assume leadership positions within the organization so these competence levels are expected to rise.
The Communication and Teamwork domain encompasses communication within the study team with outside stakeholders as well as communicating scientific results. Since the AMC is a multicenter and multinational clinical trial group, the complexity and extent of the needs for communication and teamwork are greater than that for single-center clinical trials.
The AMC CIs reported a high level of competence in managing patient participation in clinical trials in terms of recruitment and retention, and the assessment and reporting of adverse events. They felt less comfortable with managing resources for a clinical trial and site monitoring. These aspects of clinical trials require accessing site-level resources to support financial, legal, and regulatory needs.
This training needs assessment survey has been extremely informative in identifying the areas for professional development that will facilitate clinical trial workforce development at the AMC sites in Sub-Saharan Africa and LATAM. The AMC is working to incorporate professional development offerings to our investigators using an online learning management system. A general curriculum has been developed and it is now being tailored to the needs of the AMC’s clinic staff. Additionally, the AMC-specific curriculum has prioritized the release of courses, given the findings of this questionnaire.
Overall, CIs recognized the relevance of the core competencies required for conducting clinical trials, but there was variability in their self-perceived abilities to apply the competencies. Based on the self-reported competencies, a series of training and professional development modules are under development. These results will facilitate the prioritization of domains for training as the AMC expands its activities internationally and reduce any gaps in the provision of training.
Supplementary Material
To view supplementary material for this article, please visit https://doi.org/10.1017/cts.2020.520
Acknowledgments
The authors thank all AMC Site Investigators and Study Coordinators for providing their feedback to assisting with the development and implementation of the professional development training program.
This study was supported by Award Number UM1CA121947 from the National Cancer Institute, Office of HIV and AIDS Malignancies. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Contributions to the manuscript: Design and Conception (J. Lee, M. Botello-Harbaum, and M. Zozus); Development of Data Collection Instruments (J. Lee, M. Botello-Harbaum, and M. Zozus); Data Collection (R. Medina); Data Analysis (J. Lee and S. Lensing); and Critical Review of Manuscript for Intellectual Content (J. Lee, M. Botello-Harbaum, M. Zozus, R. Medina, and S. Lensing).
Disclosures
The authors have no conflicts of interest to declare.
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