Your imaging endpoint is a measurement system.

Session 1 named the problem: radiopharma trials have grown complex enough to put themselves at risk, and imaging is the discipline that manages it. But the imaging endpoint must be designed to bear that weight, and before the protocol locks.

2 → 40

Endpoints per trial. Radiopharma trials that began with two now carry 15, 20, even 40.

5–10 YRS

Phase 3 timelines, against 2–3 for comparable non-radiopharma work.

3–4

Make-or-break questions imaging can answer early, before an extended Phase 1.

Source: the Session 1 panel, as reported in the Session 1 recap. The panel's characterization of the trend, not a published dataset.

An imaging endpoint's result depends on the interaction of acquisition, disease biology, assessment criteria, reader behavior, timing, and statistical assumptions. Design those separately, or lock them after the protocol's claims are set, and the endpoint can be scientifically reasonable and still be unstable, statistically inefficient, or hard to defend. None of that principle is new. What costs radiopharma programs years is skipping it to meet a deadline.

Protocol for a defensible endpoint

4 steps

Start with the claim, not the modality

Before choosing PET, SPECT, or MRI, decide:

What change the endpoint must represent, and
Whether the treatment effect will exceed the measurement variability.

Importance is not reliability

An endpoint can matter enormously and still be too noisy to measure.
Objective is not the same as reliable.

Acquisition variability is endpoint variability

Calibration, reconstruction, motion, and timing are the endpoint's error structure. A short half-life makes those windows unforgiving.

Design the reader model, then test it

Build the charter for the hard cases.
Choose the read model around failure modes.
If a pilot disagrees, the endpoint may be what needs to change, not the training.

"It really is key to us all to look for simpler, fit-for-purpose trial design, to ensure we enable success."

Colin G. Miller, PhD, FIPEM, CSci · Session 1 recap

Session 1 named the problem.
Session 2 is where we walk through the fixes.

“Short Half-Life, Long To-Do List: Solving Early Radiopharma Development Challenges”

Session 2 · Wednesday, September 16, 2026 · 11:00 AM ET