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The end of the two-trial era

The end of the two-trial era

The two-trial era may be over. The hard part isn't.

FDA's default is now a single pivotal trial plus confirmatory evidence. Such evidence requires rigour. We advocate that target trial framework provides this rigour.

Mar 115 min read

Target trials supporting EU JCA in rare diseases

Target trials supporting EU JCA in rare diseases

EU JCA is here. Rare diseases are next. Your RWD strategy can’t wait.

EU JCA will include rare diseases from 2028. Target trial framework provides a path to incorporating real world data into strategic thinking in preparation for EU JCA inclusion.

Feb 163 min read

RWE in medical devices and beyond

RWE in medical devices and beyond

Real-world evidence needs real-world discipline: the FDA raises the bar

FDA issued a new guidance for medical devices and RWE. Applicability extends to drug development, regardless of the focus.

Jan 135 min read

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