Assessing clinical investigators' perceptions of relevance and competency of clinical trials skills: An international AIDS Malignancy Consortium (AMC) study

Abstract

Introduction: The AIDS Malignancy Consortium (AMC) conducts clinical trials of therapeutic and prevention strategies for cancer in people living with HIV. With its recent expansion to Sub-Saharan Africa and Latin America, there was a need to increase the competence of clinical investigators (CIs) to implement clinical trials in these regions.

Methods: AMC CIs were invited to complete a survey to assess role-relevance and self-perceived competence based on the Joint Task Force for Clinical Trials Competency domains.

Results: A total of 40 AMC CIs were invited to complete the questionnaire and 35 responded to the survey. The data management and informatics and engaging with communities' domains were lowest in the average proportion of CIs rating themselves high (scores of 3-4) for self-perceived competency (46.6% and 44.2%) and role-relevance (61.6% and 67.5%), whereas, the ethical and participant safety considerations domain resulted in the highest score for competency (86.6%) and role-relevance (93.3%). In the scientific concepts and research design domain, a high proportion rated for competency in evaluating study designs and scientific literature (71.4% and 74.3%) but a low proportion for competency for designing trials and specimen collection protocols (51.4% and 54.3%).

Conclusions: Given the complexity of AMC clinical research, these results provide evidence of the need to develop training for clinical research professionals across domains where self-perceived competence is low. This assessment will be used to tailor and prioritize the AMC Training Program in clinical trial development and management for AMC CIs.

Keywords: HIV malignancies; clinical trial needs assessment; core competency framework; learning objectives; training.

Fig. 1.

Domain means for relevance to role and competency. Scores for individual items (skills) were averaged within each domain. GCP, good clinical practices.