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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:

GlaxoSmithKline 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 GlaxoSmithKline at www.gsk.com

Workshop programme

12:30 Registration & Coffee

13:00 Welcome and Introductions

13:10 Introduction to Bayesian Methods

13:55 The Problems Behind Dose Finding

14:40 The Continual Reassessment Method

15:15 Afternoon Tea

15:45 Methods in Dose Escalation

16:30 General adaptive dose allocation approach (GADA)

17:15 Discussion and Questions

17:30 Close of workshop

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Crowne Plaza Hotel - St James

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Crowne Plaza Hotel - St James

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