Impact of COVID-19 on Pharmaceutical Industry: Status of Clinical Trials and Mitigation Strategies

IF 0.2 Q4 MEDICINE, GENERAL & INTERNAL
A. B. Sawad, F. Turkistani
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引用次数: 0

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.
COVID-19对制药行业的影响:临床试验现状及缓解策略
背景:COVID-19可能会影响临床试验,因为避免人与人之间的密切接触是确保个人不接触冠状病毒的建议方法之一。目的:探讨COVID-19对制药行业临床试验的影响。此外,本文还探讨了可以采取的一些策略,以应对COVID-19对临床试验的影响,从而继续进行试验的能力。方法:这是一篇叙述性综述文章。我们从许多电子数据库(PubMed/Medline、EMBASE和Cochrane Library)、谷歌搜索引擎、美国食品和药物管理局(FDA)网站以及对文章参考书目的手动搜索中获得了当前文献和指南的综合。结果:新冠肺炎疫情对临床试验有显著影响。其影响包括:削弱赞助商资助临床试验的经济能力,保持社会距离,阻碍招募非COVID-19临床试验的参与者,由于担心COVID-19感染而使参与者不愿前往临床地点,以及使试验人员选择远程工作。美国食品和药物管理局发布了在当前大流行期间适用的新指南。确保临床试验连续性的缓解战略包括:采取有利于参与者的措施、修改临床试验规程、提供后勤和供应链管理支助、采用远程数据审查和临床现场监测,以及提供额外的现场支助服务。结论:COVID-19大流行正在扰乱启动和继续进行的临床试验。必须遵循指导方针,实施减轻COVID-19不利影响的战略。应修改监测方法,以适应当前COVID-19大流行带来的限制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Archivos de Medicina
Archivos de Medicina MEDICINE, GENERAL & INTERNAL-
自引率
0.00%
发文量
15
审稿时长
24 weeks
期刊介绍: Para el desarrollo científico no sólo es necesario una constante labor investigadora, sino también una labor integradora y crítica de todos los resultados alcanzados en relación con un tema determinado que permita generar verdadero conocimiento sobre el mismo. Por otro lado, el crecimiento de la producción científica obliga a los profesionales sanitarios a constantes esfuerzos por mantenerse "al día" en cualquier disciplina de la medicina. Con esta doble función de integrar conocimientos y facilitar su difusión, nace Archivos de Medicina.
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