Panel · Use case · Medical Affairs
Treatment Effect Range.
LiveEstimate ElicitationWhat size of treatment effect on the primary endpoint should the confirmatory trial plan for, given the phase 2 result?
Treatment Effect Range is a ready-made use case for Medical Affairs. It ships under the Estimate Elicitation template.
For medical affairs leads. You get each seat's low, central and high with its anchors, the pooled range and what it is not, and what would narrow it. Claims are cited or marked as gaps.
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The decision
What size of treatment effect on the primary endpoint should the confirmatory trial plan for, given the Phase 2 result?
Who estimates
The effect to plan for is not the Phase 2 estimate. It is a judgment about what is likely to hold in a larger trial, and what would be meaningful to patients and payers.
| Seat | What it estimates from | Why it is at the table |
|---|---|---|
| Global Medical Affairs Director | The smallest effect that would matter to patients and clinicians. | Guidelines and patient input. |
| HEOR Evidence Lead | The effect payers would need to see to accept the value case. | Assessment methods. |
| Regulatory Strategist | The effect and estimand the agency would accept for approval.1 | ICH E9(R1). |
| Global Real-World Evidence Lead | How much a Phase 2 estimate is likely to shrink and what comparator data show. | Replication patterns and registries. |
What the elicitation does
Meaningful versus likely. The report separates the smallest effect worth detecting from the effect expected to hold. The two answer different questions and may differ.1
The estimand comes first. The quantity is defined with its estimand, because the same endpoint can give different effect sizes depending on how intercurrent events are handled.1
Prior elicitation is common in practice. Pharmaceutical teams have used structured elicitation to make their beliefs about success explicit for investment boards.2
Recommended length
Standard
Four angles bear on the number. Standard depth gives each a seat, with the dossier and the reasons for the spread, in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the elicitation checks
The elicitation states the assumptions each estimate rests on, and says what each gap limits. Examples for this quantity:
- The Phase 3 population matches Phase 2.
- The Phase 2 effect is not inflated by early stopping or subgroup selection.
- Missing-data handling will not change the effect.
Standards, guidance and sources
Method and anchors
The decision practice behind the memo itself is on the template page.
What gets flagged
Any effect that depends on a subgroup, any interval that excludes the Phase 2 point estimate’s uncertainty, and any estimand left implicit.
What arrives
- The quantity and how it is judged
- Evidence dossier
- Seat judgments
- Estimates side by side
- Why the seats differ
- Revised estimates after rebuttal
- The pooled range and what it is not
- What would narrow the range
What it will not do
The pool is a synthesis of AI judgments and not a calibrated distribution, and the seats are not weighted by performance. It does not narrow the range to look decisive.
It does not compute a sample size or power.
It is not a calibrated probability distribution. The pool is a synthesis of AI judgments, and the report says so.
It does not weight seats by performance. No calibration record exists for the AI seats.
It does not narrow the range to look decisive.
References
- [1] International Council for Harmonisation. ICH E9(R1): Addendum on estimands and sensitivity analysis in clinical trials. Not read.
- [2] Formal prior elicitation in drug development at GSK. arXiv:1708.09823. Abstract read; the body was unreadable.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Panel service
Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.
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