Abstract
Background: COVID-19 could affect clinical trials because avoidance of close contact between people constitutes one of the approaches that have been recommended to ensure that individuals do not become exposed to the coronavirus. Objectives: To discuss the impact of COVID-19 on clinical trials within the pharmaceutical industry. In addition, the paper examines some strategies that can be adopted to cope with impact of COVID-19 on clinical trials and thus ability to continue conducting the trials. Methods: This is a narrative review article. We provided a synthesis of current literature and guidelines obtained from searches on many electronic databases (PubMed/Medline, EMBASE, and Cochrane Library), Google search engine, the United States (US) Food and Drug Administration (FDA) website, and hand searches on the bibliography of the articles. Results: There is a significant impact of COVID-19 on clinical trials. The impact includes: undermining sponsors’ economic ability to fund clinical trials, social distancing, impeding recruitment of participants for non-COVID-19 clinical trials, discouraging participants from visiting clinical sites due to fear of COVID-19 infections, and making trial staff to opt for remote working. The US FDA published new guidelines to be applied during the ongoing pandemic. Mitigation strategies to ensure continuity of clinical trials include: adopting participant enabling measures, modifying clinical trial protocol, providing logistical and supply chain management support, embracing remote data review and clinical site monitoring, and offering extra site support services. Conclusions: COVID-19 pandemic is disrupting the initiation and continuing ongoing clinical trials. Guidelines have to be followed and strategies for mitigating adverse impacts of COVID-19 need to be applied. Modifying monitoring methods should be done to accommodate the constraints posed by the ongoing COVID-19 pandemic.
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