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Adigens Health
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Join date: Mar 26, 2024
Posts (21)
Mar 25, 2026 ∙ 6 min
Two regulators, two data frameworks. One target trial specification.
FDA and EMA assess RWE feasibility differently. Learn how the target trial framework bridges fit-for-purpose and DARWIN EU for multi-jurisdictional studies.
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Mar 11, 2026 ∙ 5 min
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.
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Feb 16, 2026 ∙ 3 min
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.
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