Knowledge, Practices and Perceptions of Good Clinical Trials Collaborative (GCTC) Guidance in the Conduct of Clinical Trials in South Africa
AHRI.GCTC.Guidance
Nompumelelo Mkwanazi
Sweetness H Dube
Africa Health Research Institute
Nesstar Publisher
Knowledge, Practices and Perceptions of Good Clinical Trials Collaborative (GCTC) Guidance in the Conduct of Clinical Trials in South Africa
AHRI.GCTC.Guidance
Njabulo Dayi
Andani Ratshinanga
Nompumelelo Mkwanazi
Sweetness Dube
Dickman Gareta
Allanise Cloete
Khethokuhle Nkosi
Londiwe Shandu
Eugene Ehlers
Eugene Prenzler
Brendan Gilbert
Anne Derache
Nompumelelo Ngobese
Limakatso Lebina
Africa Health Research Institute
Nesstar Publisher
Wellcome Trust
v1.0.0
Good Clinical Trials Collaborative (GCTC) Guidance; Community Engagement; Participant Recruitment and Retention; Clinical Trials; Research Literacy; South Africa
Clinical Trials as Topic: The overarching field of research, trial registration, and trial conduct.
Patient Selection: Covers participant recruitment, purposeful sampling, and the inclusion/exclusion of research subjects.
Community-Based Participatory Research: Encompasses community engagement, relational processes, and collaborative research
Participant recruitment and retention, as well as community engagement, are vital to the success of clinical trials, yet they are often approached as procedural rather than relational processes, limiting meaningful interaction between researchers and participants. This paper explores these dynamics as part of a broader initiative assessing knowledge and practice of the Good Clinical Trials Collaborative (GCTC) Guidance among clinical trial stakeholders in South Africa. A convergent parallel mixed-method design was adopted, with this paper focusing on the qualitative component. Purposeful sampling was used to recruit 22 key informants, including clinical trial researchers, regulatory specialists, implementation scientists, and administrative personnel. Data were analysed using thematic analysis to identify patterns and thematic structures, supported by NVivo 15 software for coding, organisation, and retrieval of qualitative data. Findings indicate that effective community engagement is often hindered by poor communication, language barriers, low research literacy, and historical mistrust stemming from past ethical breaches, contributing to misunderstandings and reduced participation. Participants highlighted the importance of transparency, including trial registration and the provision of clear, accessible information, as well as improved, contextually appropriate communication strategies to build trust, facilitate informed consent, and enhance participation. The study underscores persistent challenges related to communication and trust that affect recruitment, retention, and engagement. Addressing these challenges requires transparent, ongoing, and inclusive communication approaches that are sensitive to linguistic and cultural diversity. Strengthening relational, community-centred practices and aligning recruitment and engagement with GCTC Guidance principles are essential for promoting equity, inclusivity, and the conduct of high-quality clinical research in diverse settings such as South Africa.
South Africa
The dataset covers multiple provinces in South Africa, reflecting a broad geographic spread across key clinical research settings. Participants were drawn from diverse locations, ensuring representation across different provincial contexts.
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