A Collaborative Framework for Non-Governmental Organisation Led Clinical Trials
1
Clinical Trials Unit, Tuberculosis and HIV Investigative Network (THINK), Hillcrest, South Africa
Popul. Med. 2026;8(Supplement Supplement 1):A3725
ABSTRACT
INTRODUCTION:
Clinical trials conducted by non-governmental organisations (NGOs) in low- and middle-income countries often rely on public health primary clinics and community health centres for participant identification, referral and ongoing clinical oversight.1 Collaboration, however, is frequently undermined by fragmented communication, limited research and inadequate feedback mechanisms. These challenges negatively affect trial implementation, specifically participant recruitment, ethical compliance, operational efficiency, and trial outcomes. Addressing these systemic barriers is critical to improving clinical research within resource-limited settings.
METHODS:
A KwaZulu-Natal-based NGO implemented a multi-sectoral collaborative framework to enhance coordination, transparency, and operational efficiency of clinical research activities. The approach combined structured stakeholder mapping, early regulatory engagement, and continuous collaboration with Department of Health staff. The clinical trial unit (CTU) staff prioritised high-volume facilities to maximise recruitment efficiency and participant reach. CTU staff seconded to clinics maintained ongoing communication, provided real-time feedback on recruitment and trial progress, and used dashboards to monitor and adapt strategies.
RESULTS:
The framework led to improved stakeholder engagement, increased awareness of clinical research, and enhanced trust between NGOs, clinics, and sponsors. Regular reporting and feedback mechanisms strengthened transparency and accountability, resulting in improved referral pathways and participant tracking. Stakeholders reported higher satisfaction with communication processes, while healthcare worker engagement and morale improved. Despite persistent scepticism among some staff, continued education and dialogue positively influenced attitudes towards research participation and patient-centred care.
CONCLUSIONS:
A structured, communication-driven collaborative framework can effectively address recruitment and operational challenges in NGO-led clinical trials. Early stakeholder engagement, continuous feedback, and data-driven coordination foster trust, ethical conduct, and operational efficiency. Our model is adaptable and scalable across resource-limited settings and offers a sustainable approach to strengthening clinical research partnerships and trial performance.
Clinical trials conducted by non-governmental organisations (NGOs) in low- and middle-income countries often rely on public health primary clinics and community health centres for participant identification, referral and ongoing clinical oversight.1 Collaboration, however, is frequently undermined by fragmented communication, limited research and inadequate feedback mechanisms. These challenges negatively affect trial implementation, specifically participant recruitment, ethical compliance, operational efficiency, and trial outcomes. Addressing these systemic barriers is critical to improving clinical research within resource-limited settings.
METHODS:
A KwaZulu-Natal-based NGO implemented a multi-sectoral collaborative framework to enhance coordination, transparency, and operational efficiency of clinical research activities. The approach combined structured stakeholder mapping, early regulatory engagement, and continuous collaboration with Department of Health staff. The clinical trial unit (CTU) staff prioritised high-volume facilities to maximise recruitment efficiency and participant reach. CTU staff seconded to clinics maintained ongoing communication, provided real-time feedback on recruitment and trial progress, and used dashboards to monitor and adapt strategies.
RESULTS:
The framework led to improved stakeholder engagement, increased awareness of clinical research, and enhanced trust between NGOs, clinics, and sponsors. Regular reporting and feedback mechanisms strengthened transparency and accountability, resulting in improved referral pathways and participant tracking. Stakeholders reported higher satisfaction with communication processes, while healthcare worker engagement and morale improved. Despite persistent scepticism among some staff, continued education and dialogue positively influenced attitudes towards research participation and patient-centred care.
CONCLUSIONS:
A structured, communication-driven collaborative framework can effectively address recruitment and operational challenges in NGO-led clinical trials. Early stakeholder engagement, continuous feedback, and data-driven coordination foster trust, ethical conduct, and operational efficiency. Our model is adaptable and scalable across resource-limited settings and offers a sustainable approach to strengthening clinical research partnerships and trial performance.
| eISSN: | 2654-1459 |
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