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« Wednesday November 18, 2009 »
Wed
Planning Real-time Clinical Trial Decision Making
Start: 11/18/2009 11:00 am
End: 11/18/2009 12:30 pm

With an unprecedented scope of options now possible with new adaptive trials, how can clinical study sponsors determine their best approach?

Join noted Judith Quinlan, Cytel’s Vice President of Adaptive Trials, for an in-depth look at the most effective strategies for planning and implementing this new breed of trials.

Judith’s adaptive trial expertise and clinical experience has helped some the most successful biopharmaceutical companies pursue a winning clinical research strategy.

Actual early and confirmatory study case studies exemplify best practices proven to overcome any barriers and take full advantage of today’s era of adaptive development.

Trial planning: how do you know we have a good design?

* Asking the right development questions - how to avoid racing toward the wrong answer
* Why trial simulations? – assessing options and determining best design
* Working with colleagues – preparing internally for success
* Working with regulators
* Beyond the current trial - the impact on subsequent studies

Implementation: are you fully prepared for the consequences of adaptive changes?

* Simulation use in the execution phase, including supply forecasts and cost analysis
* Forecasting investigation site accrual rates
* Implementing the recommended changes following interim analysis

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