Dataset Information

Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis.

ABSTRACT: Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan hospitals by Chinese investigators during the urgent COVID-19 epidemic [ClincalTrials.gov NCT04257656 and NCT04252664]. These trials have been highly anticipated worldwide. We expect investigators of the trials will soon report the clinical and laboratory findings from the medical perspective. This manuscript provides documentary style information on the process of monitoring key data and making recommendations to the sponsor and investigators based on analytical insights when dealing with the emergent situation from the statistical viewpoint. Having monitored data sequentially from 237 patients, we comment on the strength and weakness of the study design and suggest the treatment effect of remdesivir on severe COVID-19 cases. Our experience with using the Dynamic Data Monitoring (DDM) tool has demonstrated its efficiency and reliability in supporting DSMB's instantaneous review of essential data during the emergent situation. DDM, when used properly by disciplined statisticians, has shown its capability of exploring the trial data flexibly and, in the meantime, protecting the trial's scientific integrity.

SUBMITTER: Shih WJ

PROVIDER: S-EPMC7229886 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis.

Shih Weichung J WJ Yao Chen C Xie Tai T

Therapeutic innovation & regulatory science 20200516 5

Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan hospitals by Chinese investigators during the urgent COVID-19 epidemic [ClincalTrials.gov NCT04257656 and NCT04252664]. These trials have been highly anticipated worldwide. We expect investigators of the trials will soon report the clinical and laboratory findings from the medical perspective. This manuscript provides documentary style information ...[more]

PMID: 32865809

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Project description:A pandemic calls for large-scale action across national and international innovation systems in order to mobilize resources for developing and manufacturing crisis-critical products efficiently and in the huge quantities needed. Nowadays, these products also include a wide range of digital innovations. Given that many responses to the pandemic are technology driven, stakeholders involved in the development and manufacturing of crisis-critical products are likely to face intellectual property (IP)-related challenges. To (governmental) decision makers, IP challenges might not appear to be of paramount urgency compared to the many undoubtedly huge operational challenges to deploy critical resources. However, if IP challenges are considered too late, they may cause delays to urgently mobilize resources effectively. Innovation stakeholders could then be reluctant to fully engage in the development and manufacturing of crisis-critical products. This article adopts an IP and innovation perspective to learn from the currently unfolding COVID-19 pandemic using secondary data, including patent data, synthesized with an IP roadmap. We focus on technical aspects related to research, development, and upscaling of capacity to manufacture crisis-critical products in the huge volumes suddenly in demand. In this article, we offer a set of contributions. We provide a structure, framework, and language for those concerned with steering clear of IP challenges to avoid delays in fighting a pandemic. We provide a reasoning why IP needs to be considered earlier rather than too late in a global health crisis. Major stakeholders we identify include 1) governments; 2) manufacturing firms owning existing crisis-critical IP (incumbents in crisis-critical sectors); 3) manufacturing firms normally not producing crisis-critical products suddenly rushing into crisis-critical sectors to support the manufacturing of crisis-critical products in the quantities that far exceed incumbents' production capacities; and 4) voluntary grassroot initiatives that form during a pandemic, often by highly skilled engineers and scientists in order to contribute to the development and dissemination of crisis-critical products. For these major stakeholders, we draw up three scenarios, from which we identify associated IP challenges they face related to the development and manufacturing of technologies and products for 1) prevention (of spread); 2) diagnosis of infected patients; and 3) the development of treatments. This article provides a terminology to help policy and other decision makers to discuss IP considerations during pandemics. We propose a framework that visualizes changing industrial organizations and IP-associated challenges during a pandemic and derive initial principles to guide innovation and IP policy making during a pandemic. Obviously, our findings result only from observations of one ongoing pandemic and thus need to be verified further and interpreted with care.

Dataset Information

Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis.

Publications

Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis.

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