Real-time Clinical Trial Decision Making
|Event Date/Time: Nov 18, 2009||End Date/Time: Nov 18, 2009|
Join noted Judith Quinlan, Cytelâ€™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.
Judithâ€™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 todayâ€™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? â€“ assessing options and determining best design
* Working with colleagues â€“ 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