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Latest From Janssen R&D LLC

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.

Real-World Evidence Clinical Trials

Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough

Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.

Clinical Trials Compliance

Benefit-Risk Math: US FDA Still Favors Simple Calculations

A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
Drug Approval Standards Drug Review

Real-World Evidence: Observational Studies Deserve More Respect In US FDA Framework

Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.

Drug Approval Standards Clinical Trials
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