Using Adaptive Designs to Avoid Selecting the Wrong Arms in Multiarm Comparative Effectiveness Trials [0.03%]
使用自适应设计避免多臂比较疗效试验中选择错误的治疗方案
Byron J Gajewski,Jeffrey Statland,Richard Barohn
Byron J Gajewski
Limited resources are a challenge when planning comparative effectiveness studies of multiple promising treatments, often prompting study planners to reduce the sample size to meet the financial constraints. The practical solution is often ...
Bayesian Approach for Assessing Non-inferiority in Three-arm Trials for Risk Ratio and Odds Ratio [0.03%]
基于贝叶斯方法的相对效应三臂试验非劣效性评价功效函数及其样本量公式研究风险比和比数比
Shrabanti Chowdhury,Ram C Tiwari,Samiran Ghosh
Shrabanti Chowdhury
In this paper we consider three-arm non-inferiority (NI) trial that includes an experimental, a reference, and a placebo arm. While for binary outcomes the risk difference (RD) is the most common and well explored functional form for testin...
Incorporating biomarkers to improve statistical power of immunotherapeutic neoadjuvant clinical trials in patients with triple-negative breast cancer [0.03%]
将生物标志物纳入免疫新辅助临床试验以提高三阴性乳腺癌的统计功效
Feng Gao,Guoqiao Wang,Jingqin Luo et al.
Feng Gao et al.
Neoadjuvant (preoperative) approach to breast cancer treatment has become widely accepted. Traditionally the primary objective of neoadjuvant treatment is to improve subsequent surgical intervention and the effectiveness are often evaluated...
Borrowing from Historical Control Data in Cancer Drug Development: A Cautionary Tale and Practical Guidelines [0.03%]
基于历史对照数据进行借贷在癌症药物研发中的警示故事和实践指南
Connor Jo Lewis,Somnath Sarkar,Jiawen Zhu et al.
Connor Jo Lewis et al.
Some clinical trialists, especially those working in rare or pediatric disease, have suggested borrowing information from similar but already-completed clinical trials. This paper begins with a case study in which relying solely on historic...
Martin Posch,Peter Bauer
Martin Posch
We consider situations where a drug developer gets access to additional financial resources when a promising result has been observed in a pre-planned interim analysis during a clinical trial which should lead to the registration of the dru...
Time to All-cause Treatment Discontinuation as the Primary Outcome in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Study [0.03%]
精神分裂症治疗临床疗效评估(CATIE)研究中所有原因导致停药的生存时间作为主要指标分析
Sonia M Davis,T Scott Stroup,Gary G Koch et al.
Sonia M Davis et al.
Time until all-cause treatment discontinuation was the primary outcome of the CATIE trial. We discuss the advantages and disadvantages of this outcome, and evaluate its association with clinical correlates through graphical response profile...
Evaluation of drug combination effect using a Bliss independence dose-response surface model [0.03%]
基于Bliss独立剂量效应曲面模型的药物组合作用评价方法
Qin Liu,Xiangfan Yin,Lucia R Languino et al.
Qin Liu et al.
To test the anticancer effect of combining two drugs targeting different biological pathways, the popular way to show synergistic effect of drug combination is a heat map or surface plot based on the percent excess the Bliss prediction usin...
An adaptive dose-finding design based on both safety and immunologic responses in cancer clinical trials [0.03%]
基于安全性和免疫学反应的癌症临床试验中的自适应剂量寻找设计
Cody Chiuzan,Elizabeth Garrett-Mayer,Michael Nishimura
Cody Chiuzan
Dose-finding in cancer clinical trials has been dominated by algorithmic designs on the principle that the highest tolerable dose is also the most effective dose. This assumption no longer applies to the biologic treatments that are charact...
A Ivanova,K M Anderson,Gary L Rosner et al.
A Ivanova et al.
We congratulate the authors on their comments on innovative approaches to drug development that fall out of the traditional mold and may result in more quickly bringing safe and effective treatments to patients. Changes in the overall clini...
Group Sequential Survival Trial Design and Monitoring Using the Log-Rank Test [0.03%]
基于检验统计量的序贯生存试验设计与监控方法研究
Jianrong Wu,Xiaoping Xiong
Jianrong Wu
For randomized group sequential survival trial designs with unbalanced treatment allocation, the widely used Schoenfeld formula is inaccurate, and the commonly used information time as the ratio of number of events at interim look to the nu...