Literature DB >> 28966721

Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model.

Jianrong Wu1.   

Abstract

For designing single-arm phase II trials with time-to-event endpoints, a sample size formula is derived for the modified one-sample log-rank test under the proportional hazards model. The derived formula enables new methods for designing trials that allow a flexible choice of the underlying survival distribution. Simulation results showed that the proposed formula provides an accurate estimation of sample size. The sample size calculation has been implemented in an R function for the purpose of trial design.

Entities:  

Keywords:  contiguous alternative; one-sample log-rank test; proportional hazards model; sample size; single-arm phase II trial; time-to-event

Year:  2017        PMID： 28966721      PMCID： PMC5619878          DOI： 10.1080/19466315.2016.1174147

Source DB:  PubMed          Journal:  Stat Biopharm Res        ISSN： 1946-6315            Impact factor:   1.452


  13 in total

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Authors:  Leonidas E Bantis; John V Tsimikas; Stelios D Georgiou
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2.  Estimating the loss in expectation of life due to cancer using flexible parametric survival models.

Authors:  Therese M-L Andersson; Paul W Dickman; Sandra Eloranta; Mats Lambe; Paul C Lambert
Journal:  Stat Med       Date:  2013-08-23       Impact factor: 2.373

3.  Designing phase II studies in cancer with time-to-event endpoints.

Authors:  Kouros Owzar; Sin-Ho Jung
Journal:  Clin Trials       Date:  2008       Impact factor: 2.486

4.  Single-arm Phase II cancer survival trial designs.

Authors:  Jianrong Wu
Journal:  J Biopharm Stat       Date:  2015-06-22       Impact factor: 1.051

5.  Planning the size and duration of a clinical trial studying the time to some critical event.

Authors:  S L George; M M Desu
Journal:  J Chronic Dis       Date:  1974-02

6.  Phase II clinical trials with time-to-event endpoints: optimal two-stage designs with one-sample log-rank test.

Authors:  Minjung Kwak; Sin-Ho Jung
Journal:  Stat Med       Date:  2013-12-13       Impact factor: 2.373

7.  Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation.

Authors:  L V Rubinstein; M H Gail; T J Santner
Journal:  J Chronic Dis       Date:  1981

8.  Introduction to sample size determination and power analysis for clinical trials.

Authors:  J M Lachin
Journal:  Control Clin Trials       Date:  1981-06

9.  Phase II cancer clinical trials with a one-sample log-rank test and its corrections based on the Edgeworth expansion.

Authors:  Xiaoqun Sun; Paul Peng; Dongsheng Tu
Journal:  Contemp Clin Trials       Date:  2010-10-01       Impact factor: 2.226

10.  Evaluation of sample size and power for multi-arm survival trials allowing for non-uniform accrual, non-proportional hazards, loss to follow-up and cross-over.

Authors:  F M-S Barthel; A Babiker; P Royston; M K B Parmar
Journal:  Stat Med       Date:  2006-08-15       Impact factor: 2.373
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  1 in total

1.  Two-stage phase II survival trial design.

Authors:  Jianrong Wu; Li Chen; Jing Wei; Heidi Weiss; Aman Chauhan
Journal:  Pharm Stat       Date:  2019-11-21       Impact factor: 1.234
  1 in total

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