TL11: Statistical methods in benefit-risk assessment
*Yueqin Zhao, FDA Keywords: MCDA, visualization Although regulatory agents evaluate the risks and benefits of any new drug during the new drug-approval process, no consensus on quantitative assessment of benefit risk has been reached. Various structured benefit risk models and methods have been proposed, such as Multi-criteria decision analysis (MCDA), Quality-adjusted time without symptoms and toxicity (Q-TWiST), number needed to treat (NNT) and number needed to harm (NNH), Benefit-less-risk analysis(BLRA), Risk-benefit Contour (RBC), and so on. In this roundtable, we will address the following questions: 1. What are the commonly used models and statistical methods in benefit-risk assessment, in both the industry and regulatory agency? What are the advantages and disadvantages? 2. What are the commonly used visualization methods in benefit-risk evaluations? 3. How can the benefit-risk assessment be bridged between pre-approval clinical trials with the post-approval surveillance?
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC