Evidax Insights

Expert notes on generating comparative evidence

All insights

  • Dr Sam Orange

    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?

  • Dr Sam Orange

    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.

  • Dr Sam Orange

    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.

If your pivotal trial gets you approval but not reimbursement, we should talk.