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Bayesian Adaptive Dose Finding Studies
3 February - 4 February 2009
Bayesian Adaptive Dose Finding Studies

Dose finding is an important part of clinical development.  It is essential that the correct dose is chosen for confirmatory studies, for the drug to have successful registration and therefore be available to patients.  It is estimated that approximately 20% of post approval changes are is dose.  Recently, adaptive clinical trials have been proposed for dose exploration, and within the PhRMA organisation there has been a working group set up to look into dose finding.  One of their finding was that Bayesian adaptive dose finding could perform better than other methods.  It is now expected that adaptive methods will be used more regularly in the exploratory phases of development, which some lead to a more informed choice of dose.

This workshop will give a brief introduction to the concepts behind Bayesian adaptive dose finding.  The methods will be illustrated using real life examples.

About your Workshop Leader:

Alun Bedding; Director, Biostatistics and Development Programming Partners, is a global consultant in Bayesian methods and adaptive trials within GSK.  He has worked in this area for many years and has a number of publications in them.

About the Organisation:

GlaxoSAE Media GroupthKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSAE Media GroupthKline at www.gsk.com

Workshop agenda

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12:30

Registration & Coffee

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13:00

Welcome and Introductions

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13:10

Introduction to Bayesian Methods

  • What are Bayesian methods?
  • Bayesian methods and prediction
  • Comparison with traditional methods
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    13:55

    The Problems Behind Dose Finding

  • Traditional dose finding
  • Regulatory requirements
  • How can we improve dose finding
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    14:40

    The Continual Reassessment Method

  • What is the CRM
  • Applications in oncology
  • Application outside oncology, including a trial in migraine
  • Comparison to other methods
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    15:15

    Afternoon Tea

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    15:45

    Methods in Dose Escalation

  • Univariate methods using a binary or continuous endpoint
  • Bivariate methods
  • An example in a drug to treat venous thrombo embolisms
  • An example in type II diabetes
  • The use of optimal design theory and its application
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    16:30

    General adaptive dose allocation approach (GADA)

  • The new breed of adaptive dose response trials
  • ASTIN revisited, and other examples
  • An example in respiratory
  • Seamless development
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    17:15

    Discussion and Questions

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    17:30

    Close of workshop

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

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