Adigens Health

The Target trial framework ran through many sessions, posters and pre-conference training at the 42nd ISPE conference in Milan. Across oncology, diabetes, chronic kidney disease, pregnancy and vaccines, it was not presented as a new method. Most sessions assumed it rather than introduced it, and the methodological discussion was largely about how to apply it rather than whether to. Its extensions, such as the TARGET reporting guidelines and the clone-censor-weighting are following the same path.

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.

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.