Adigens Health

Regulators are already approving ultra-targeted therapies on the basis of biological plausibility and tiny datasets. Payers, meanwhile, are being asked to fund them at scale – often with little idea what they will deliver in real-world practice. In the era of bespoke and ultra-targeted therapies, RWE can’t just mean a case series and a few registry plots. It needs to behave like a trial, even when no one is randomised.

Real-world evidence (RWE) has long promised to bridge the chasm between what works in trials and what happens in practice. Yet over the past few years, it has done something bolder; it has crossed into the realm of comparative evidence. The “real-world comparator,” which used to be dismissed as an oddity of rare disease research has quietly become one of the most contested frontiers in evidence generation.  This topic was discussed during the recent Adigens Health webinar featuring Uwe...

RWE requires transparency. Target trial emulation offers it and now there is an explicit statement on how to report the findings.