Predictive event modelling in multicenter clinical trials with waiting time to response [0.03%]
多中心临床试验中具有对等待时间响应的预测事件模型
Vladimir V Anisimov
Vladimir V Anisimov
A new analytic statistical technique for predictive event modeling in ongoing multicenter clinical trials with waiting time to response is developed. It allows for the predictive mean and predictive bounds for the number of events to be con...
Why a Bayesian approach to safety analysis in pharmacovigilance is important [0.03%]
药品不良反应信号检测的贝叶斯方法为什么重要
David Prieto-Merino,George Quartey,Jixian Wang et al.
David Prieto-Merino et al.
Large databases of routinely collected data are a valuable source of information for detecting potential associations between drugs and adverse events (AE). A pharmacovigilance system starts with a scan of these databases for potential sign...
Investigating the assumption of homogeneity of treatment effects in clinical studies with application to meta-analysis [0.03%]
临床研究中治疗效应齐性的假设检验及其在meta分析中的应用
Steven A Julious,Anne Whitehead
Steven A Julious
An important part of the evaluation of a therapy is an investigation of the assumption of homogeneity of its effect across pre-defined subpopulations. In this paper we describe simple graphical presentations that could be used to assess the...
Katherine Hutchinson,John W Stevens
Katherine Hutchinson
Jonathan Bright,Mike Aylott,Simon Bate et al.
Jonathan Bright et al.
In 2010, the Statisticians in the Pharmaceutical Industry (PSI) Toxicology Special Interest Group met to discuss the design and analysis of the Comet assay. The Comet assay is one potential component of the package of safety studies require...
George Quartey,Maurille Feudjo-Tepie,Jixian Wang et al.
George Quartey et al.
Observational epidemiological studies are increasingly used in pharmaceutical research to evaluate the safety and effectiveness of medicines. Such studies can complement findings from randomized clinical trials by involving larger and more ...
A review of risk measures in pharmacoepidemiology with tips for statisticians in the pharmaceutical industry [0.03%]
药物流行病学中风险测量的综述及对制药行业中统计学家的一些建议
George Quartey,Jixian Wang,Joseph Kim
George Quartey
Pharmacoepidemiology is the study of the therapeutic effects, risk, and use of drugs in large populations, which applies epidemiological methods and reasoning. As reflected in the recent strengthening of the pharmacovigilance legislation in...
Statistical aspects in comparative benefit-risk assessment: challenges and opportunities for pharmaceutical statisticians [0.03%]
比较疗效风险评估中的统计学问题：药品统计学家面临的挑战与机遇
George Quartey,Jixian Wang
George Quartey
Benefit-risk assessment is a fundamental element of drug development with the aim to strengthen decision making for the benefit of public health. Appropriate benefit-risk assessment can provide useful information for proactive intervention ...
Adjusting for covariates in non-inferiority studies with margins defined as risk differences [0.03%]
以风险差异定义边界的非劣效性试验中的混杂变量控制
Khadeeja Mohamed,Andrew Embleton,Robert L Cuffe
Khadeeja Mohamed
Adjusting for covariates makes efficient use of data and can improve the precision of study results or even reduce sample sizes. There is no easy way to adjust for covariates in a non-inferiority study for which the margin is defined as a r...
Aaron Dane
Aaron Dane
The increasing concern of antibacterial resistance has been well documented, as has the relative lack of antibiotic development. This paradox is in part due to challenges with clinical development of antibiotics. Because of their rapid prog...