12 PICOs, five unanswered: what Itvisma teaches about EU JCA
The first national assessment using an EU JCA shows why comparative evidence needs coverage, credibility and restraint.
Evidax Insights
The first national assessment using an EU JCA shows why comparative evidence needs coverage, credibility and restraint.
Two analysts can combine the same studies of a medicine and report different confidence intervals. The method matters most when the evidence is sparse, heterogeneous or uneven.
Studies can evaluate the same medicine but recruit very different patients. Adjusting for reported study-level characteristics can produce a more relevant meta-analysis benchmark.
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.
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.
A regulatory evidence package can secure approval and still leave the medicine unfunded. These are the five questions payers need your evidence to answer.
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.
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.