Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19 [0.03%]
COVID-19 影响下的临床试验的安全性评估及相关申报注意事项
Mary Nilsson,Brenda Crowe,Greg Anglin et al.
Mary Nilsson et al.
Abstract-In this article, we provide guidance on how safety analyses and reporting of clinical trial safety data may need to be modified, given potential impact from the COVID-19 pandemic. Impact could include missed visits, alternative met...
Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19 [0.03%]
针对COVID-19干预措施的临床试验的有效自适应设计
Nigel Stallard,Lisa Hampson,Norbert Benda et al.
Nigel Stallard et al.
The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clinical trials to evaluate potential therapies for COVID-19. Th...
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience [0.03%]
在正在进行的临床试验中嵌入COVID-19序贯临床试验的罕见经验与教训
Pierre-François Dequin,Amélie Le Gouge,Elsa Tavernier et al.
Pierre-François Dequin et al.
The Cape-Covid trial is an embedded clinical trial within the ongoing Cape-Cod trial. The Covid-19 pandemic appeared while we were conducting a randomized trial assessing the effectiveness of corticosteroids in severe community-acquired pne...
Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue? [0.03%]
新冠疫情对临床试验的影响：适应性设计能否救场？
Cornelia Ursula Kunz,Silke Jörgens,Frank Bretz et al.
Cornelia Ursula Kunz et al.
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of conseq...
Assessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints [0.03%]
通过模拟评估世界卫生组织的新冠肺炎终点指标的操作特征
Michael O&#x;Kelly,Siying Li
Michael O&#x;Kelly
Many clinical trials of treatments for patients hospitalised for COVID-19 use an ordinal scale recommended by the World Heath Organisation. The scale represents intensity of medical intervention, with higher scores for interventions more bu...
The Impact of Major Events on Ongoing Noninferiority Trials, With Application to COVID-19 [0.03%]
重大事件对正在进行的非劣效性试验的影响及其在COVID-19方面的应用
Brian L Wiens,Ilya Lipkovich
Brian L Wiens
Abstract-The COVID-19 pandemic has impacted ongoing clinical trials. We consider particular impacts on noninferiority clinical trials, which aim to show that an investigational treatment is not markedly worse than an existing active control...
Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic [0.03%]
新冠疫情期间中国临床试验的实践经验及统计学问题探讨
Tong Guo,Chian Chen,Chieh Chiang et al.
Tong Guo et al.
The COVID-19 outbreak is impacting clinical trials in many ways, such as patient recruitment, data collection and data analysis. To proceed in this difficult time, the adoption of new technologies and new approaches for conducting clinical ...
Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials-Application of the Estimand Framework [0.03%]
COVID-19对肿瘤临床试验研究目标和分析的影响评估——估算量框架的应用
Evgeny Degtyarev,Kaspar Rufibach,Yue Shentu et al.
Evgeny Degtyarev et al.
Abstract-Coronavirus disease 2019 (COVID-19) outbreak has rapidly evolved into a global pandemic. The impact of COVID-19 on patient journeys in oncology represents a new risk to interpretation of trial results and its broad applicability fo...
Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials [0.03%]
评估COVID-19大流行对临床试验的完整性和可解释性的影响面临的挑战
Mouna Akacha,Janice Branson,Frank Bretz et al.
Mouna Akacha et al.
Abstract-The COVID-19 pandemic has a global impact on the conduct of clinical trials of medical products. This article discusses implications of the COVID-19 pandemic on clinical research methodology aspects and provides points to consider ...