To assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trials design and conduct, a Working Group was formed by the Clinical Pharmacology Leadership Group within the International Consortium for Innovation and Quality in Pharmaceutical Development. The Working Group collected and summarized data for IQ member companies' experience on impact of the pandemic on design and conduct of clinical trials, the extent of missed doses and missing pharmacokinetic/pharmacodynamic data, and implementation of mitigation strategies.

As of August 30, 2023, there have been over 770 million confirmed cases of coronavirus disease 2019 (COVID-19) and nearly 7 million deaths reported to the World Health Organization.¹ The pandemic has led to significant changes in clinical research conducted to evaluate the safety and efficacy of both COVID-19 and non-COVID-19 treatments.^2-5

To help assess the impact of the COVID-19 pandemic on clinical trials design and conduct, a Working Group was formed in 2020 by the Clinical Pharmacology Leadership Group within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium). The IQ COVID-19 Working Group aimed to collect data for IQ member companies' experience on the impact of the pandemic on design and conduct of clinical trials, the extent of missed doses, and missing pharmacokinetic (PK)/pharmacodynamic (PD) data, and implementation of mitigation strategies. Additionally, case studies that refer to the experience of IQ companies were collected and are presented herein.

为了评估 2019 年冠状病毒病 (COVID-19) 大流行对临床试验设计和实施的影响，国际药物开发创新与质量联盟的临床药理学领导小组成立了一个工作组。工作组收集并总结了 IQ 成员公司在疫情对临床试验设计和实施的影响、错过剂量和缺失药代动力学/药效数据的程度以及缓解策略实施方面的经验数据。

截至 2023 年 8 月 30 日，世界卫生组织向世界卫生组织报告的 2019 年冠状病毒病 (COVID-19) 确诊病例已超过 7.7 亿例，近 700 万人死亡。¹大流行导致评估 COVID-19 和非 COVID-19 治疗的安全性和有效性的临床研究发生重大变化。^2-5

为了帮助评估 COVID-19 大流行对临床试验设计和实施的影响，国际药物开发创新和质量联盟（IQ 联盟）的临床药理学领导小组于 2020 年成立了一个工作组。 IQ COVID-19 工作组旨在收集 IQ 成员公司的经验数据，了解大流行对临床试验设计和实施的影响、错过剂量的程度以及缺失的药代动力学 (PK)/药效学 (PD) 数据，和缓解策略的实施。此外，还收集并介绍了涉及 IQ 公司经验的案例研究。