Curtailed two-stage designs with two dependent binary endpoints

Chia Min Chen, Yun-Chan Chi

Research output: Contribution to journalReview article

1 Citation (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)57-62
Number of pages6
JournalPharmaceutical Statistics
Volume11
Issue number1
DOIs
Publication statusPublished - 2012 Jan 1

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All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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