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Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.

Publication ,  Journal Article
Lu, Q; Tse, SK; Chow, S-C
Published in: J Biopharm Stat
July 2010

In recent years, the use of a two-stage seamless design in clinical trials has attracted much attention. A two-stage seamless trial design is referred to as a study design that combines two separate clinical studies that are normally conducted to achieve separate objectives, such as a phase II study for treatment selection and a phase III study for efficacy confirmation. Furthermore, it is not uncommon to consider study endpoints with different treatment durations at different stages (see, e.g., Chow and Chang, 2006; Maca et al., 2006). Chow et al. (2007) and Lu et al. (2009) considered the cases where the study endpoints are continuous variables and binary responses, respectively. In this article, our attention is placed on the case where the study endpoints are time-to-event data with different treatment durations. For testing equality, superiority, and noninferiority/equivalence of two treatments, test statistics for the analysis of the combined data collected from the two stages are developed for Weibull distributed data. In addition, formulas for sample size calculation and sample size allocation between the two stages for each of the hypotheses are derived. Corresponding results are also derived under Cox's proportional hazards model.

Duke Scholars

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

July 2010

Volume

20

Issue

4

Start / End Page

705 / 719

Location

England

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Therapeutic Equivalency
  • Statistics & Probability
  • Sample Size
  • Proportional Hazards Models
  • Models, Statistical
  • Likelihood Functions
  • Humans
  • Epidemiologic Research Design
 

Citation

APA
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MLA
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Lu, Q., Tse, S. K., & Chow, S.-C. (2010). Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. J Biopharm Stat, 20(4), 705–719. https://doi.org/10.1080/10543401003618066
Lu, Qingshu, Siu Keung Tse, and Shein-Chung Chow. “Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.J Biopharm Stat 20, no. 4 (July 2010): 705–19. https://doi.org/10.1080/10543401003618066.
Lu Q, Tse SK, Chow S-C. Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. J Biopharm Stat. 2010 Jul;20(4):705–19.
Lu, Qingshu, et al. “Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials.J Biopharm Stat, vol. 20, no. 4, July 2010, pp. 705–19. Pubmed, doi:10.1080/10543401003618066.
Lu Q, Tse SK, Chow S-C. Analysis of time-to-event data under a two-stage survival adaptive design in clinical trials. J Biopharm Stat. 2010 Jul;20(4):705–719.

Published In

J Biopharm Stat

DOI

EISSN

1520-5711

Publication Date

July 2010

Volume

20

Issue

4

Start / End Page

705 / 719

Location

England

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Therapeutic Equivalency
  • Statistics & Probability
  • Sample Size
  • Proportional Hazards Models
  • Models, Statistical
  • Likelihood Functions
  • Humans
  • Epidemiologic Research Design