Interim analysis in clinical trials: caution against premature conclusions—the SWOG multiple myeloma S0777 case study [PDF]
TrialsBackground Interim monitoring for efficacy and futility provides critical decision-making boundaries on early termination of randomized clinical trials.
Emily Goren +3 more
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Adaptive designs for trials aiming to optimise implementation strategies and the effect of an additional interim analysis: a simulation study [PDF]
BMC Medical Research MethodologyTrials that aim to optimise the implementation of an intervention are often complex, requiring multiple, combined strategies and requiring uptake on multiple levels.
Erin Nolan +5 more
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Trial sequential analysis: novel approach for meta-analysis [PDF]
Anesthesia and Pain Medicine, 2021 Systematic reviews and meta-analyses rank the highest in the evidence hierarchy. However, they still have the risk of spurious results because they include too few studies and participants.
Hyun Kang
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Adaptive designs for clinical trials
Kerala Journal of Ophthalmology, 2021 The gold standard for interventional studies is the randomized controlled trial (RCT). The RCT follows a linear path with prespecified plans and a little option for flexibility within its implementation.
Praveen K Nirmalan
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临床试验中的成组序贯设计 Group Sequential Design in Clinical Trials
Zhongguo cuzhong zazhi, 2022 近年来，成组序贯设计因其可在期中分析时提前得出结论结束试验，具有更强的灵活性，已被广泛应用于临床试验中。本文将从背景、设计思路、与传统临床试验的比较、使用场景、案例解读、设计要点和报告规范等对该方法进行简单介绍。 Abstract: In recent years, the group sequential design has been widely used in clinical trials, because this design can draw conclusions in ...
胥芹, 张怡君, 田雪, 夏雪, 张晓丽, 李静, 王安心
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Frontiers in Pharmacology, 2023 A delayed treatment effect is a commonly observed phenomenon in tumor immunotherapy clinical trials. It can cause a loss of statistical power and complicate the interpretation of the analytical findings.
Long-Shen Xie, Hui Lu
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Prognostic value of whole-body dynamic 18F-FDG PET/CT Patlak in diffuse large B-cell lymphoma
Heliyon, 2023 Objective: This study aims to investigate the significance of interim whole-body dynamic 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) Patlak parameters for predicting the prognosis of patients with diffuse ...
Jiankang Yin +5 more
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THE EXPORT COMPETITIVENESS OF SOCIAL ENTERPRISES AS COMPARED TO WITH EXPORT SMES
Revista Galega de Economía, 2017 Purpose – This study aims to determine the export competitiveness of the Social Economy in Andalusia, this is carried out by quantifying the export competitiveness of the internationalized enterprises of the Social Economy in the export sector of the ...
Arturo GUTIÉRREZ FERNÁNDEZ +1 more
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Eight predictive powers with historical and interim data for futility and efficacy analysis
Statistical Theory and Related Fields, 2022 When the historical data of the early phase trial and the interim data of the Phase III trial are available, we should use them to give a more accurate prediction in both futility and efficacy analysis. The predictive power is an important measure of the
Ying-Ying Zhang +2 more
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Experience collecting interim data on mortality: an example from the RALES study
Current Controlled Trials in Cardiovascular Medicine, 2001 Introduction The Randomized Aldactone Evaluation Study (RALES) randomized 822 patients to receive 25 mg spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes.
Kulbertus Henri +8 more
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