TL20: Safety Monitoring of Events of Interest in Placebo-Controlled Clinical Trials
*Bradley McEvoy, CDER, FDA *Elena Polverejan, Johnson & Johnson Keywords: safety monitoring, stopping rules Unblinded safety monitoring of events of interest could be performed by a Data Monitoring Committee (DMC), as well as a regulatory agency. Stopping rules based on events of interest are sometimes pre-specified in trial protocols. In placebo-controlled clinical trials, the comparison of the occurrence of events of interest in the active arms versus placebo is of particular interest. The applied statistical methods include odds ratio, methods taking into account differences in treatment duration between arms (hazard ratio, incidence rate ratio) or various Bayesian methods. If the pre-specified stopping rules are met or some concern threshold is met then the DMC, the sponsor or a regulatory agency could decide at some time point during the study to stop an active arm, a study or all the studies within a project. The participants will share their views and experience on this topic. Key Discussion Questions: 1. What statistical methods could be applied for comparisons versus placebo, stopping rules, identification of a vulnerable patient subgroup? Any preference? 2. What stopping rules don’t involve statistical methods? 3. When is safety monitoring of events of interest not a statistical issue?
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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