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.
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Real-World Reluctance? Despite Guidance, Drug Developers Wary Of RWE-Based Trials
Biopharma companies are reluctant to rely on real-world evidence trials, but while uncertainty remains about how these novel studies will be accepted, US and other regulators are encouraging drug developers to take a chance – and some have taken on the challenge.
Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife
The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away.
Real-World Evidence: Sponsors Will Need Prospective Process Early In Development
US FDA's approach to clinical trial replication project may offer tips for sponsors looking to use real-world evidence to support drug development.