3 期临床试验的 "得分-金锁 "设计。

IF 1.2 4区医学 Q4 PHARMACOLOGY & PHARMACY

Journal of Biopharmaceutical Statistics Pub Date : 2024-07-12 DOI:10.1080/10543406.2024.2374850

Yingqiu Li, Xun Zhang, Zhimao Weng

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引用次数: 0

摘要

本文提出了一种新的贝叶斯自适应设计--得分-金锁设计，其算法思想与金锁设计相同。得分-金发姑娘设计通过使用正态近似，得出了计算不同终点试验成功概率的统一公式。仿真结果表明，得分-金锁设计不仅在第一类误差、功率、平均样本量、无效停止概率、成功提前停止概率等运行特征方面与金锁设计非常相似，而且大大节省了计算时间，提高了运行效率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The score-goldilocks design for phase 3 clinical trials.

In this paper, we propose a new Bayesian adaptive design, score-goldilocks design, which has the same algorithmic idea as goldilocks design. The score-goldilocks design leads to a uniform formula for calculating the probability of trial success for different endpoint trials by using the normal approximation. The simulation results show that the score-goldilocks design is not only very similar to the goldilocks design in terms of operating characteristics such as type 1 error, power, average sample size, probability of stop for futility, and probability of early stop for success, but also greatly saves the calculation time and improves the operation efficiency.

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来源期刊

Journal of Biopharmaceutical Statistics 医学-统计学与概率论

CiteScore

2.50

自引率

18.20%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers: Drug, device, and biological research and development; Drug screening and drug design; Assessment of pharmacological activity; Pharmaceutical formulation and scale-up; Preclinical safety assessment; Bioavailability, bioequivalence, and pharmacokinetics; Phase, I, II, and III clinical development including complex innovative designs; Premarket approval assessment of clinical safety; Postmarketing surveillance; Big data and artificial intelligence and applications.