An inclusive clinical trial Research Education Programme for investigators in Health Sciences

Abstract

Upscaling the pool of clinical trial investigators is critical to address the evolving challenges of clinical trials and meet the increasing demand for skilled health professionals. By developing an inclusive clinical trial research education programme for investigators in health sciences, that includes nurses and other health professionals in South Africa, the study aimed to ensure a diverse and well-equipped workforce capable of navigating the complexities of modern clinical trials and contributing to advancements in healthcare. A sequential exploratory qualitative-driven multiple-method quasi-experimental design was employed to achieve this objective, consisting of three projects. The Medical Research Council (MRC) framework was adopted to guide the process, acknowledging the dynamic nature of developing an education programme. Project 1 explored and described stakeholders’ perspectives of an inclusive clinical trial research education programme. Ten experienced clinical trial professionals were interviewed to develop and validate the programme. Project 2 involved the programme’s implementation with 28 investigators, including nurses, pharmacists, statisticians, and social workers, registering for participation. This phase was quantitative in nature Project 3 evaluated the clinical trial research education programme, encompassing both quantitative and qualitative segments. The 28 participants from Project 2 formed the basis of the quantitative evaluation. Pre- and post-questionnaires were used to assess changes in participants’ self-perceived competency and knowledge of clinical trials after the intervention. Additionally, five participants were selected for qualitative evaluation through interviews. Qualitative findings from the study indicated that participants’ need for clinical trial education was met, while quantitative results supported these findings by demonstrating a significant improvement in participants’ self-perceived competency and knowledge of clinical trials following the intervention. The developed inclusive clinical trial research education programme provides explicit recommendations for various stakeholders, including nurses, educators, supervisors, and the clinical trial industry, to use the programme and ensure well-trained clinical trial professionals who can contribute to favourable patient outcomes. In conclusion, upscaling the pool of clinical trial investigators through an inclusive education programme is essential for meeting the challenges of modern clinical trials and the growing demand for skilled health professionals. This study demonstrates the effectiveness of such a programme in enhancing participants’ competencies and knowledge.