Curtailed two-stage designs with two dependent binary endpoints

Chia Min Chen, Yun-Chan Chi

研究成果: Review article

1 引文 斯高帕斯(Scopus)

摘要

When phase I clinical trials were found to be unable to precisely estimate the frequency of toxicity, Brayan and Day [1] proposed incorporating toxicity considerations into two-stage designs in phase II clinical trials. Conaway and Petroni [2] further pointed out that it is important to evaluate the clinical activity and safety simultaneously in studying cancer treatments with more toxic chemotherapies in a phase II clinical trial. Therefore, they developed multi-stage designs with two dependent binary endpoints. However, the usual sample sizes in phase II trials make these designs difficult to control the type I error rate at a desired level over the entire null region and still have sufficient power against reasonable alternatives. Therefore, the curtailed sampling procedure summarized by Phatak and Bhatt [3] will be applied to the two-stage designs with two dependent binary endpoints in this paper to reduce sample sizes and speed up the development process for drugs.

原文English
頁(從 - 到)57-62
頁數6
期刊Pharmaceutical Statistics
11
發行號1
DOIs
出版狀態Published - 2012 一月 1

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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