RMST: survival benefit HTA committees can use
Restricted mean survival time expresses treatment benefit in months and remains interpretable when hazards are not proportional. But the population and time horizon must be designed first.
Evidax Insights
Expert notes on generating comparative evidence
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Five reasons biotechs need an IEP
The stakeholders deciding whether to approve, reimburse, and prescribe your drug have different questions. To answer them all, biotechs need a plan.
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Heterogeneity in indirect comparisons: your design matters
Heterogeneity is the most common criticism made of indirect comparisons in European HTA. By the time it arrives, its causes are already fixed in the design.
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External control arms: how and when
When your trial has no suitable control you can build one from outside it. The first decision shapes everything that follows: patient-level data, or summary data?
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AI in evidence generation: what regulators and HTA bodies say
Regulators, HTA bodies and evidence-synthesis standard-setters have started to say how AI may be used in evidence generation. Across very different institutions, they converge on the same answer.
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When there's no head-to-head: a field guide to indirect treatment comparisons
A field guide to indirect treatment comparisons: why you reach for one, the toolbox from Bucher to ML-NMR, who accepts them, and the handful of things that separate a robust ITC from a fragile one.
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100 days: what the EU JCA means for your evidence plan
The EU Joint Clinical Assessment gives you 100 days to answer comparative questions you did not choose. Here is how it works, and what it changes about when evidence planning has to start.