Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial

Abstract

Conducting randomized clinical trials (RCTs) during a pandemic is essential for obtaining timely evidence on safe and effective treatments, but it presents numerous obstacles. During the COVID-19 pandemic, the World Health Organization (WHO) sponsored multinational RCTs investigating repurposed drugs among hospitalized COVID-19 patients across countries with varying clinical research capacities. In Nigeria, several challenges hindered our progress, including inadequate infrastructure, initial insufficient investigator certification and expertise, and delays in securing regulatory approvals due to bureaucratic hurdles. Despite these challenges, the WHO-sponsored Solidarity Plus Trial (SPT) offered valuable opportunities to enhance research capacity, streamline participant enrolment through electronic randomization, and bolster infection prevention and control measures for healthcare workers. Moreover, the trial enabled us to upgrade infrastructure at multiple sites, facilitating improved case detection through more testing and data collection. A crucial lesson learned was the importance of expediting trial initiation to capitalize on the limited window for data collection during an outbreak. To optimize RCTs during pandemics, we advocate for enhanced community engagement, collaborative efforts across sectors, strengthened research capacity, flexible regulatory frameworks, and the establishment of adaptive clinical trial units. By addressing these challenges and leveraging opportunities, we can significantly enhance the efficiency and impact of RCTs during public health emergencies.