Setting up Contract Research Organizations in Sub-Saharan Africa: Challenges, Opportunities, and Prospects; A Qualitative Study
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Date
2024-10-15
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Addis Ababa University
Abstract
Background: A Contract Research Organization (CRO) is a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. Africa, emerging as a powerhouse of clinical research, presents significant opportunities for CROs. Despite the benefits of CROs, there is a lack of understanding of the challenges, opportunities and prospects of setting up CROs in sub-Saharan Africa.
Objective: To explore the setting up, challenges, opportunities and prospects of CROs in sub Saharan Africa and to suggest the way forward for improved practice. Methods: This qualitative research used a phenomenological study design. A semi-structured interview guide was used for the in-depth interviews with 13 CRO participants from nine sub Saharan African countries, both face-to-face and virtually. Combination of purposive sampling procedure using criterion and snowball sampling were employed for study participant selection. Data collection took place from July 2023 to June 2024. Data was analyzed using thematic analysis, performed with ATLAS. ti version 8.4.24
Results: Five themes were identified: setting up of CROs, challenges of CROs, strategies used to overcome challenges, opportunities of CROs, and prospects of CROs in sub-Saharan Africa. To establish a CRO workforce and infrastructures are needed. Lack of regulations and bureaucratic challenges were the major identified challenge in homegrown CROs. Collaboration, partnerships, community engagement and creation of a strong networking platform were used to overcome their challenges. Opportunities like market potential and untapped industry were reported. Based on these findings, participants recommended that all regulatory bodies in their respective countries establish clear requirements and standards for setting up CROs.
Conclusion: Challenges faced by CROs reveals essential strategies that sponsors, regulatory bodies, and new CROs can adopt to understand how established CROs navigate and overcome operational difficulties. Countries should support emerging CROs due to the significant opportunities and needs in this field. Furthermore, collaboration among stakeholders is essential to leverage this opportunity and foster the expansion of the CRO sector in sub-Saharan Africa.
Key-words: Challenges, Opportunities, Prospects, CRO, sub-Saharan Africa
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Challenges Opportunitie Prospects CRO sub-Saharan Africa