Review of clinical trials in South Africa between 2019 to 2021: An assessment of delayed clinical trials within the COVID-19 pandemic in South Africa

Abstract

Background: Clinical trials are essential for new medicines to reach the healthcare system, improving community health and life expectancy, and playing a crucial role in advancing the field of medicine since no drug can be approved without undergoing rigorous clinical trials before market release. However, during the COVID-19 pandemic, the progress of clinical trials was delayed, and the quality thereof was compromised. Aim: This study aimed to review the implications of delays in clinical trials, whether start-up or approval, due to the coronavirus disease in South Africa 2019 (COVID-19). Method: The study conducted a desk review of industry-sponsored clinical trials, to systematically review SAHPRA-registered Phase II–III clinical trials in South Africa between 2019–2021. This study is a systematic narrative review of SAHPRA-registered Phase II–III clinical trials conducted in South Africa between 2019–2021, synthesizing peer-reviewed literature and authoritative reports. The study analyzed data over the first 24 months of the pandemic. Published research articles between 2019 and 2023 served as the data source. Correlation between the severity of the COVID-19 pandemic and clinical trials performed and the cost implication of pausing clinical trials were analysed. Databases such as Google Scholar, PubMed, ScienceDirect, Scopus, MEDLINE, Embase and Web of Science were used. The review followed PRISMA 2020 reporting guidance, with dual independent screening, documented search strings, predefined eligibility criteria, and risk-of-bias appraisal.