RL36 Evaluate Overall Survival with Crossover in Oncology Clinical Trials
*Xin Huang, Pfizer Keywords: Overall survival (OS) is recognized as the gold standard for clinical benefit in oncology clinical trials. However, the formal demonstration of the underlying survival benefit of a treatment can be diluted or confounded by effective later treatment. Although oncology trials have the objective of comparing the experimental arm with the control arm for OS, statistical analyses of OS by Intention-to-treatment (ITT) treatment groups based on conventional approaches are biased towards the null because of the crossover. This has been a great challenge in oncology drug development and regulatory approval. In this roundtable luncheon, we hope to stimulate discussions about the possible approaches in designing trials and estimating the underlying treatment effect of OS when crossover is present.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC