Skip to main content
SpringerLink
Log in
Book cover

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics pp 121–125Cite as

A Statistical Decision Framework Applicable to Multipopulation Tailoring Trials

  • Conference paper
  • First Online:

  • 905 Accesses

Part of the book series: ICSA Book Series in Statistics ((ICSABSS))

Abstract

Interest in tailored therapeutics has led to innovations in trial design and analysis. Trials now range from traditional overall population trials with exploratory subgroup analysis to single population tailoring trials, to multipopulation tailoring trials. This paper presents an overview of the trial options and provides a framework for decision making in confirmatory multipopulation tailoring trials.

This is a preview of subscription content, log in via an institution.

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   189.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   249.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   249.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  • Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER-2 positive breast cancer. New England Journal of Medicine. 2005; 353: 1673–1684.

    Google Scholar 

  • Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomized, placebo-controlled phase 3 study. Lancet Oncology. 2010; 11:521–529.

    Google Scholar 

  • [Tarceva US product label]. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021743sl4s16lbl.pdf. Accessed April 6, 2013.

  • Millen BA, Dmitrienko A, Mandrekar SJ, Zhang Z, and Williams DA. Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations. Therapeutic Innovation and Regulatory Science. 2014; 48: 453–462.

    Google Scholar 

  • Millen BA, Dmitrienko A, Ruberg S, and Shen L. A statistical framework for decision making in confirmatory multipopulation tailoring trials. Therapeutic Innovation and Regulatory Science. 2012; 46: 647–656.

    Google Scholar 

  • Millen BA, Dmitrienko A, and Song G. Bayesian assessment of the influence and interaction conditions in multipopulation tailoring clinical trials. Journal of Biopharmaceutical Statistics. 2014; 24: 94–109.

    Google Scholar 

  • Ding Y, Lin H-M, and Hsu JC. Subgroup mixable inference on treatment efficacy in mixture populations, with an application to time-to-event outcomes. Statistics in Medicine. 2016; 35: 1580–1594.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Eli Lilly and Company, Lilly Corp. Center, Indianapolis, IN, USA

    Brian A. Millen

Authors
  1. Brian A. Millen
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Brian A. Millen .

Editor information

Editors and Affiliations

  1. Global Statistics, Takeda Pharmaceuticals, Cambridge, Massachusetts, USA

    Jianchang Lin

  2. Biostatistics, Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, USA

    Bushi Wang

  3. Colorado State University , Fort Collins, Colorado, USA

    Xiaowen Hu

  4. University of Connecticut , Storrs, Connecticut, USA

    Kun Chen

  5. Global Statistics, Takeda Pharmaceuticals Global Statistics, Cambridge, Massachusetts, USA

    Ray Liu

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this paper

Cite this paper

Millen, B.A. (2016). A Statistical Decision Framework Applicable to Multipopulation Tailoring Trials. In: Lin, J., Wang, B., Hu, X., Chen, K., Liu, R. (eds) Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics. ICSA Book Series in Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-42568-9_10

Download citation

Publish with us

Policies and ethics

Search

Navigation