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Real-World Evidence, Digital Health, Insurance Coverage Reforms On Cures 2.0 Agenda

Executive Summary

All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.

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US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'

CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.

RWE: Comparators, Therapeutic Area May Be Key For Trial Replication

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.

HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon

US proposed rule establishing new safe harbors from anti-kickback rules for value-based and outcomes-based contracts limits protections to clinicians, providers and certain other groups and expressly excludes pharmaceutical manufacturers. But HHS suggests a separate safe harbor for prescription drug contracts may be forthcoming.

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