Correspondence

Clinical trial capacity in African primary care: Advancing contextualised implementation

Schawanya K. Rattanapitoon, Nav La, Jun Norkaew, Nathkapach K. Rattanapitoon

Received: 31 July 2025; Accepted: 27 Sept. 2025; Published: 06 Nov. 2025

Copyright: © 2025. The Author(s). Licensee: AOSIS.
This work is licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license (https://creativecommons.org/licenses/by/4.0/).

Responding to Mash et al.: Urgency, equity, and pragmatism in African primary care trials

We commend Mash and colleagues¹ for their timely and thorough exposition of clinical trial methodology, tailored to the realities of family medicine and primary care. Their article not only highlights the critical underutilisation of randomised controlled trials in low- and middle-income countries – particularly in African primary care but also provides an incisive roadmap for methodological advancement. We write to reinforce and expand their recommendations, arguing that contextualised implementation science must be central to strengthening Africa’s clinical trial ecosystem.

Bridging efficacy to effectiveness: The need for pragmatic and hybrid designs

Mash et al. appropriately differentiate between efficacy and effectiveness trials.¹ We further suggest that hybrid effectiveness – implementation designs – which simultaneously assess clinical outcomes and implementation processes – are particularly suited to African settings, where understanding contextual barriers (e.g. health worker shortages, cultural acceptability, infrastructural deficits) is as important as evaluating clinical benefit. These hybrid models have shown value in primary care mental health interventions across sub-Saharan Africa² and should now be mainstreamed in family medicine research.

Expanding trial participation through decentralisation and digital innovation

The authors rightly highlight the limited participation of African primary care in global trials. One underexplored lever is decentralised clinical trials (DCTs) that use digital tools and community health infrastructure to enable recruitment, consent and data collection at the household or village level. Early pilots in West Africa during the coronavirus disease 2019 (COVID-19) pandemic demonstrated the feasibility of such models even in bandwidth-constrained environments.³ Investment in DCTs may also reduce urban-rural trial disparities, a long-standing equity concern.

Community co-production and ethical governance

We support the call for robust ethical frameworks and emphasise that community co-production – not just engagement – must underpin trial design and execution. In contexts where historical research exploitation remains salient, ensuring transparent benefit-sharing, data sovereignty and community authorship rights is not only ethical but enhances trial relevance and sustainability.

Conclusion

Mash et al.¹ provide a vital foundation for early career researchers in family medicine. To advance their vision, we must integrate hybrid implementation methodologies, digital trial decentralisation and decolonised governance models. These steps will not only improve methodological rigour but also ensure that trials are grounded in the lived realities of African primary care systems.

Acknowledgements

The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.

S.K.R. was involved in conceptualisation, literature review, writing – original draft, writing – review and editing. N.K.R. performed supervision, formal analysis, validation, writing – review and editing. N.L. and J.N. were involved in validation, writing – review and editing. All authors approved the final version.

This article followed all ethical standards for research without direct contact with human or animal subjects.

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Data sharing is not applicable to this article as no new data were created or analysed in this study.

The views and opinions expressed in this article are those of the authors and are the product of professional research. It does not necessarily reflect the official policy or position of any affiliated institution, funder, agency or that of the publisher. The authors are responsible for this article’s results, findings and content.

References