Accounting for non-adherence: A re-analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results trial [0.03%]
考虑不依从性：利拉鲁肽疗效和作用在糖尿病：心血管结果试验的再分析
Kathrine Kold Sørensen,Johan Sebastian Ohlendorff,Anders Munch et al.
Kathrine Kold Sørensen et al.
Background/aims: The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results trial randomized patients with diabetes to liraglutide or placebo. The per-protocol analysis conditioned on post...
Rami Hawila,Susan Halabi,Ruitao Lin et al.
Rami Hawila et al.
Background: In this article, we introduce a Phase I clinical trial design that utilizes late-onset toxicity outcomes to determine group-specific doses when groups are partially ordered before the trial. By "partially orde...
Trial informed consent forms, the Declaration of Helsinki and the SPIRIT 2025 statement [0.03%]
《赫尔辛基宣言》《SPIRIT 2025声明》与试验知情同意书
Rafael Dal-Ré,Arthur L Caplan
Rafael Dal-Ré
17th Annual University of Pennsylvania Conference on statistical issues in clinical trials - Covariate adjustment in randomized clinical trials: New methods and applications (Afternoon panel discussion) [0.03%]
第十七届宾夕法尼亚大学统计学临床试验年度大会-随机临床试验中的协变量调整：新方法和应用(下午专题讨论会)
Frank Harrell,Dylan S Small
Frank Harrell
Adaptive trial design and interim decision-making using incomplete longitudinal measurements: Methods and application to myasthenia gravis [0.03%]
基于不完整纵向指标的适应性临床试验设计与期中决策：方法及重症肌无力的应用研究
Kush Kapur,Fien Gistelinck,An Vandebosch et al.
Kush Kapur et al.
Sample size re-estimation designs using a promising zone framework are widely used adaptive trial methodologies that guide study continuation or modification during interim analyses. Conventional implementations often base interim calculati...
Covariate adjustment in randomized clinical trials: From general theory to practical insights [0.03%]
随机临床试验中的协变量调整：从一般理论到实用见解
Marlena S Bannick,Yanyao Yi,Ting Ye
Marlena S Bannick
Covariate adjustment uses baseline prognostic variables to improve the precision of treatment effect estimates. Recent Food and Drug Administration guidance and scientific consensus emphasize three principles for its use, namely estimand-fo...
Daniel F Heitjan
Daniel F Heitjan
Background: Although the analysis of event-based clinical trials commonly relies on assumptions about the underlying hazard functions, in practice it is rare to see estimates of those functions. ...
Surrogate markers used as efficacy endpoints in NIH-sponsored clinical trials [0.03%]
美国国立卫生研究院资助的临床试验中用作疗效终点的替代标志物
Ayman Mohammad,Samuel Yoon,Joshua D Wallach et al.
Ayman Mohammad et al.
Stuart J Pocock
Stuart J Pocock
This article aims to provide a practical overview of the various methods of covariate adjustment in randomized clinical trials leading to recommendation for future practice. Topics covered are baseline adjustment for a quantitative outcome ...