Panel · Use case · Medical Affairs
Surrogate Endpoint Divergence.
LiveDivergence ReviewMap where specialists disagree on whether a surrogate endpoint is adequate evidence of clinical benefit, and what would settle it.
Surrogate Endpoint Divergence is a ready-made use case for Medical Affairs. It ships under the Divergence Review template.
For medical affairs and regulatory leads. You get each seat's answer to the same question, where the positions diverge, whether each split is evidence, assumption or value, the cruxes and what would settle it. Claims are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
Is a surrogate endpoint adequate evidence of clinical benefit for a chronic disease therapy?
Who is at the table
A surrogate endpoint stands in for a clinical outcome. Regulators accept some for approval and treat others as reasonably likely to predict benefit, while payers often ask for the clinical outcome itself.
| Seat | What it is asked | What it works from |
|---|---|---|
| Global Medical Affairs Director | Whether clinicians would treat the surrogate as meaningful for patients. | Guidelines and clinical practice. |
| Regulatory Strategist | Whether the surrogate is validated for the disease, or reasonably likely to predict benefit.1,2 | FDA’s surrogate endpoint table and the BEST glossary. |
| HEOR Evidence Lead | Whether payers will accept the surrogate or demand clinical outcomes. | Payer assessment methods. |
| Global Value & Evidence Lead | What the link between surrogate and outcome rests on, and how strong it is. | Trial-level and patient-level association studies. |
What the review does
The same word, different standards. A regulator, a clinician and a payer use “adequate” differently. The review separates the regulatory standard from the clinical and the payer one and shows which seat uses which.1,2
The crux is the link. Whether a change in the surrogate predicts a change in outcome is a fact. If the seats disagree on it, the review names the evidence that would settle it.2
What would settle it. A named analysis of the surrogate against the outcome, or the interim result of an outcome trial, with the decision each would inform.
Recommended length
Standard
Four disciplines will read this question differently. Standard depth types each divergence as evidence, assumption or value in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the review checks
The review states the assumptions each position relies on, and says what each gap limits. Examples for this question:
- The link between surrogate and outcome holds for this mechanism of action.
- Patients and clinicians value the surrogate on its own.
- The agency will treat the surrogate in this disease as it has in related diseases.
Standards, guidance and sources
Frame
The decision practice behind the memo itself is on the template page.
What gets flagged
Any claim that a surrogate is validated without a named analysis, any seat that treats approval and payer acceptance as one standard, and any link supported by one trial.
What arrives
- The question as put
- The shape of the disagreement
- Each position, in its own terms
- Where they diverge
- Why they diverge: evidence, assumption or value
- The cruxes
- What would settle it
What it will not do
It does not force a consensus, and it is a deliberation of AI specialists and not a vote of human experts. The decision stays with you.
It does not advise on a filing or on a label claim.
It does not force a consensus. A report that closes every gap would be the wrong output.
It is not a vote of human experts. Every seat is an AI specialist, and the report says so.
It does not name a winner. It says what would settle the question and leaves the decision to you.
References
- [1] U.S. Food and Drug Administration. Surrogate Endpoint Resources for Drug and Biologic Development. Known from FDA’s site; not read in full.
- [2] FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Bethesda: National Institutes of Health. Known from the NCBI Bookshelf listing; not read in full.
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.
To edit a saved template, open New → Panel → From template, or the library rail on the service form.