RL08 Analysis of Time-to-Event Data with Low Event Rates
*Estelle Russek-Cohen, U.S. Food and Drug Administration Keywords: Sponsors develop a series of clinical trials including Phase III trials that are randomized pivotal trials used in support of a drug label. If the drug label will state that the drug is to be used in only a subset of patients that are identified via an in vitro test (e.g. those above a pre-specified cutoff using a tumor marker assay) then the sponsor is expected to have the in vitro test come to CDRH Office of In Vitro Devices for review. Two centers would provide (coordinated) advice to a sponsor and then there would need to be a submission for CDRH and a submission for CDER (or CBER depending on the therapy).
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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
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