Survival with Rare Outcomes: Examples from Diagnostic Device Trials
View Presentation *Estelle Russek-Cohen, U.S. Food and Drug Administration Keywords: survival, sample size In survival analysis, when event rates are low, the effective sample size is often considerably less than the number of patients. I would like to discuss two examples from diagnostic device trials. The first example has come up in the evaluation of prognostic markers for patients diagnosed at an early stage of a chronic disease such as cancer. The second example has come up in a trial in which “adverse events” are the primary endpoint.
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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