Perspectives of stakeholders on post-trial access arrangements in Ethiopia: a qualitative study

While there is limited practical experience and guidance on post-trial access (PTA) in clinical trials in low- and middle-income countries, the concept of benefit-sharing is firmly established in international ethical guidelines. Few studies have been conducted in sub-Saharan African on PTA despite its importance in distributive justice. This study aims to explore the stakeholders' perspectives on PTA and its feasibility in Ethiopia. An exploratory qualitative study using in-depth interviews was conducted with 22 stakeholders involved in clinical trials study and review. Deductive thematic analysis was used to analyze the data. We found that research participants had limited knowledge on PTA. They opined that both trial participants and communities should benefit from clinical trials and multi-stakeholder collaboration was key in PTA planning and arrangements. However, they were uncertain of PTA feasibility in Ethiopia mostly due to a lack of legislation, regulations and guidelines on PTA and fear of losing sponsors because of increased costs resulting from them being obligated to provide PTA. It was recommended that Ethiopia establishes legislation and guidelines to govern PTA. Multi-stakeholder engagement in PTA planning and arrangements is key for meaningful PTA as the responsibility is shouldered by all parties.