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

Autor: Opawoye A; Lagos University Teaching Hospital, Lagos, Nigeria., Kwaghe V; University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Habib ZG; University of Abuja Teaching Hospital, Gwagwalada, Abuja, Nigeria., Jibrin Y; Abubakar Tafawa Balewa University Teaching Hospital, Bauchi, Nigeria., Maigari I; Abubakar Tafawa Balewa University Teaching Hospital, Bauchi, Nigeria., Hussaini B; Aminu Kano Teaching Hospital, Kano, Nigeria., Adekanmbi O; University College Hospital, Ibadan, United Kingdom., Unigwe U; University of Nigeria Teaching Hospital, Enugu, Nigeria., Ayoola O; Federal Ministry of Health, Abuja, Nigeria., Osibogun A; Lagos University Teaching Hospital, Lagos, Nigeria., Salami K; World Health Organization, Geneva, Switzerland., Preziosi MP; World Health Organization, Geneva, Switzerland., Habib AG; Aminu Kano Teaching Hospital, Kano, Nigeria. Electronic address: aghabib.med@buk.edu.ng.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Nov 13; Vol. 147, pp. 107743. Date of Electronic Publication: 2024 Nov 13.
DOI: 10.1016/j.cct.2024.107743
Abstrakt: 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.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The author (AGH) is an Editorial Board Member/Editor-in-Chief/Associate Editor/Guest Editor for [PLoS Neglected Tropical Diseases; Toxicon; Toxin Reviews] and was not involved in the editorial review or the decision to publish this article.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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