TL23: Clinical Trial Design with Presence of Long-Term Survivors
*Jim Xiang, ASA, IBS Keywords: Survival analysis, long-term survivors Long-term survivors in clinical trials are those patients who are ‘cured’ after receiving treatments and have no chance to reach the primary endpoints, such as disease progression or death due to the underlying diseases. According to the formal definition of censoring in the survival analysis, the event, such as disease progression, will happen after the censoring time. Censoring long-term survivors at the end of trial isn’t consistent to this definition and may introduce potential bias in the survival analysis. When long-term survivors are present in the clinical trials, it will prolong the trial enrollment duration and may end up underpowered due to insufficient events. In this roundtable discussion, we will focus on following issues • How to detect if there exist long-term survivors • Is the follow-up sufficient to detect long-term survivors • If long-term survivors are not avoidable, how to determine the sample size or treatment duration • What analyses are appropriate if long-term survivors exist? Our ultimate goal is to come up with a general guidance or consensus in the clinical trial design. References for this discussion include the book by Ross Maller and Xian Zhou “Survival Analysis with long-Term Survivors”, (1996) by John Wiley & Sons, and other recent publications in the literature.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC