Literature DB >> 31718458

Group sequential design for historical control trials using error spending functions.

Jianrong Wu1, Yimei Li2.   

Abstract

Group sequential designs using Lan-DeMets error spending functions are proposed for historical control trials with time-to-event endpoints. Both O'Brien-Fleming and Gamma family types of sequential decision boundaries are derived based on sequential log-rank tests, which follow a Brownian motion in a transformed information time. Simulation results show that the proposed group sequential designs using historical controls preserve the overall type I error and power.

Entities:  

Keywords:  Error spending function; decision boundaries; group sequential design; historical control; information time

Mesh:

Year:  2019        PMID: 31718458      PMCID: PMC7737423          DOI: 10.1080/10543406.2019.1684305

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN: 1054-3406            Impact factor:   1.051


  14 in total

1.  A sequential procedure for monitoring clinical trials against historical controls.

Authors:  Xiaoping Xiong; Ming Tan; James Boyett
Journal:  Stat Med       Date:  2007-03-30       Impact factor: 2.373

2.  Group sequential designs using a family of type I error probability spending functions.

Authors:  I K Hwang; W J Shih; J S De Cani
Journal:  Stat Med       Date:  1990-12       Impact factor: 2.373

3.  Required duration and power determinations for historically controlled studies of survival times.

Authors:  L J Emrich
Journal:  Stat Med       Date:  1989-02       Impact factor: 2.373

4.  Sequential monitoring of clinical trials: the role of information and Brownian motion.

Authors:  K K Lan; D M Zucker
Journal:  Stat Med       Date:  1993-04-30       Impact factor: 2.373

5.  Sample size considerations for non-randomized comparative studies.

Authors:  R W Makuch; R M Simon
Journal:  J Chronic Dis       Date:  1980

6.  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

7.  A multiple testing procedure for clinical trials.

Authors:  P C O'Brien; T R Fleming
Journal:  Biometrics       Date:  1979-09       Impact factor: 2.571

8.  Survival trial design and monitoring using historical controls.

Authors:  Jianrong Wu; Xiaoping Xiong
Journal:  Pharm Stat       Date:  2016-06-15       Impact factor: 1.894

9.  Sample size considerations for historical control studies with survival outcomes.

Authors:  Hong Zhu; Song Zhang; Chul Ahn
Journal:  J Biopharm Stat       Date:  2015-06-22       Impact factor: 1.051

10.  Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves.

Authors:  Patricia Guyot; A E Ades; Mario J N M Ouwens; Nicky J Welton
Journal:  BMC Med Res Methodol       Date:  2012-02-01       Impact factor: 4.615

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