How to reconstruct pseudo IPD from a survival curve
When true patient-level survival data are unavailable, a published Kaplan–Meier curve may be reconstructed as pseudo IPD. Here is how to do it, what to validate and where the method stops.
Evidax Insights
Expert notes on generating comparative evidence
All insights
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Compared with what?
A comparator can satisfy a regulator and still miss what payers and clinicians need. Here is how to plan the direct and indirect comparisons that support approval, reimbursement and prescribing.
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Approval is not access: five questions payers will ask
A regulatory evidence package can secure approval and still leave the medicine unfunded. These are the five questions payers need your evidence to answer.
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Trial recruitment: six tips no one tells you
A strong site can still recruit poorly. Six practical lessons on planning, accountability, screening logs, simple tools and coffee vouchers, from people who have been there and done it.
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Beyond endpoints: measuring what matters to payers and patients
Some benefits never reach a medical record or pivotal endpoint. The answer is not to measure everything. It is to collect the smallest amount of evidence that could change a decision.
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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.
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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.