Pragmatic Considerations for Endpoint Selection and Display in Benefit-Risk Assessment
View Presentation *Bennett Levitan, Janssen Research & Development, LLC Zhong Yuan, Janssen Research & Development, LLC Keywords: benefit-risk assessment, endpoint, composite, clinical trials While there are numerous approaches for drug benefit-risk assessment, most share the need for a structured approach to select the endpoints included in the assessment. The requirements for endpoints in benefit-risk are not always considered when designing clinical trials, and in some cases may not align. Approaches for benefit-risk endpoint selection include using a single composite endpoint that combines benefits and harms, a pair of endpoints that compares an efficacy composite to a safety composite, and characterization of the full set of benefits and harms. These approaches vary in their ease of interpretation, potential for double-counting, mixing of events with varying clinical impact and in their ability to show core tradeoffs. This presentation will compare and provide pragmatic examples of these approaches for setting up and displaying results of a benefit-risk assessment.
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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