Volume 2 · recruiting soon
Meaningful Change
Volume 2 takes on the question every trial eventually asks: how much change actually matters? Anchors, thresholds, responder definitions, and the evidence each one needs to stand up.
What it will cover
The question every trial eventually asks
Volume 1 established how two measures move together. Volume 2 asks how much movement counts. Writing has not started. We will open it to contributors shortly, and the form below is how you hear about it first.
Anchors
External references for interpreting change, what makes a defensible one, and where anchor-based estimates go wrong. Volume 1 introduces anchors on slide 76 and leaves the argument open.
Thresholds and responder definitions
Where a meaningful-change threshold comes from, how a responder definition is built on top of one, and what evidence a regulator expects behind it.
Methods, all three kinds
How the evidence is generated. Qualitative work, where patients say in their own words what a difference feels like. Quantitative work, anchor-based and distribution-based. And mixed methods, where the two are designed to answer each other rather than sit side by side in an appendix.
Be part of it
Meaningful Change
Volume 2 takes on the question every trial eventually asks: how much change actually matters? Anchors, thresholds, responder definitions, and the evidence each one needs to stand up.
In the meantime