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Session 2 - Meta-analysis for Safety Assessment
Session Chair(s)
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
Aloka Chakravarty, PhD
Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
This session will have a particular focus on "network meta-analysis" for assessment of product safety. Standard meta-analysis, whether of continuous or discrete outcomes, has focused exclusively on comparing two treatments or classes of treatments. Recently, methods have been developed to integrate comparisons of multiple treatments into coherent models that allow simultaneous comparison of all treatments. Applications of these methods are beginning to become popular in the clinical literature. Called variously network meta-analysis, multiple treatments meta-analysis and mixed treatment comparisons, the basic idea is that the direct evidence from head-to-head trials may be combined with the indirect evidence from trials that involve common comparators. For instance, trials of A vs. B and A vs. C give indirect information about the comparison of B vs. C under the assumption of consistency that the direct and indirect comparisons estimate the same quantity. Our speaker will discuss basic principles of networks and their analysis including the assumptions of consistency and treatment of heterogeneity and will discuss the validity of these assumptions in the context of safety studies relative to efficacy studies. Some important features of safety data to be discussed include length of follow-up, rare events, varying patient populations, differing exposures, variation in medical practice, age of treatments, trial sponsor. Extensions to multiple outcomes and longitudinal designs with incomplete data will also be discussed. A panel will discuss questions related to meta-analysis, network meta-analysis and the FDA Public Meeting on meta-analysis held November 2013.
Speaker(s)
Network Meta-Analysis for Safety Assessment
Christopher H. Schmid, PhD
Brown University School of Public Health, United States
Professor of Biostatistics, Center for Evidence Based Medicine
Panelists
Mark Levenson, PhD
FDA, United States
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
Jesse Berlin, DrSc
Johnson & Johnson, United States
Senior Vice President, Epidemiology
Amy Xia, PhD
Amgen Inc., United States
Vice President, Center for Design and Analysis
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