Strategies to build trust in the conduct of clinical trials: Stakeholders' views in a qualitative study in Ghana

Abstract

While clinical trials have evolved and improved over time producing significant advances in diagnosis, treatment and prevention of diseases, there are equally key challenges such as feasibility of some clinical trials and most importantly the issue of trust in the conduct of clinical trials. Thus, this study provides scientific evidence to address challenges associated with clinical trials conduct as well as a framework describing appropriate trust building strategies to guide the conduct of future clinical trial studies in Ghana and beyond. The study used qualitative research approach where 48 in-depth and Key informant interviews were conducted with participants between June and August, 2019. The interviews were recorded, transcribed and coded into themes using QSR Nvivo 12 software before thematic content analysis. The results revealed low level of trust in the conduct of clinical trials in Ghana. Participants recommended several trust building strategies to improve trust across the clinical trial cycle. Pre-implementation strategies such as effective stakeholder engagement and strengthening clinical trial regulatory bodies were recommended to build community trust. Implementation strategies such as effective monitoring, addressing issues of untrustworthiness and misconceptions regarding drawing and use of blood samples, improved informed consent procedures as well as post-implementation strategy such as timely feedback to clinical trial communities were highly recommended to build trust in clinical trials conduct. Trust is an important factor affecting clinical trials conduct especially in developing countries. The need to invest in national and community level trust-building activities through appropriate stakeholder engagement and effective monitoring systems by clinical trial regulatory bodies are critical strategies to improve trust in clinical trials conduct.