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Adigens Health
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Join date: Mar 26, 2024
Posts (28)
Aug 18, 2026 ∙ 5 min
Pre-specify, or explain yourself later
Two FDA advisory committee meetings, held a day apart, expose two distinct pre-specification failures: a randomised trial whose analysis plan was rewritten after unblinding, and a single-arm trial that never properly specified its external control arm.
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Jul 7, 2026 ∙ 3 min
The unfinished business of target trial emulation
At GetReal Institute's 2026 conference in Utrecht, stakeholders discussed the future of the target trial framework. Adigens Health led the workshop—here's what's at stake, and why a white paper is coming.
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Jun 23, 2026 ∙ 6 min
EHDS: framework in place, infrastructure still missing
New guidance from TEHDAS2 clarifies how the European Health Data Space will govern pharmaceutical access to real-world data. The problems it leaves unresolved matter more for observational studies built in a target trial framework than the problems it solves.
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