Continuous Safety Monitoring for Randomized Controlled Clinical Trials with Blinded Treatment Information
View Presentation *Greg Ball, Astellas Pharma Global Development Keywords: Safety Monitoring, Clinical Trials, Blinded Treatment We design early stopping rules for harm that act as continuous safety screens for randomized controlled clinical trials with blinded treatment information, which could be used by anyone, including trial investigators. A Bayesian framework, with emphasis on the likelihood function, is used to allow for continuous monitoring without adjusting for multiple comparisons. Close collaboration between the statistician and the clinical investigators will be needed in order to design safety screens with good operating characteristics. Though the math underlying this procedure may be computationally intensive, implementation of the statistical rules will be easy. Trial leadership need these safety screens to help them to effectively monitor the ongoing safe conduct of clinical trials with blinded data.
|
Key Dates
-
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