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ICER Partnering With Aetion To Scale Up Use Of RWE In Value Assessments

Executive Summary

Aetion is also working with the US Food and Drug Administration and a number of biopharma companies on projects involving use of real-world evidence.

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ICER Will Assess Real World Evidence On Accelerated Approvals After Two Years

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It may be easier to use observational study data to replicate randomized controlled trial results in certain therapeutic areas or where drugs were studied against each other instead of placebo, the US FDA’s David Martin says; the agency-funded DUPLICATE real-world evidence demonstration project has completed replication work on the first five trials, all of which are diabetes drug cardiovascular outcomes studies.

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