Panel · Use case · Clinical Operations
Trial Design Divergence.
LiveDivergence ReviewMap where specialists disagree on site-based versus decentralized design for a Phase 3 trial, and what would settle it.
Trial Design Divergence is a ready-made use case for Clinical Operations. It ships under the Divergence Review template.
For clinical operations 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
Should a Phase 3 trial in atopic dermatitis use a site-based, hybrid or decentralized design?
Who is at the table
FDA describes a decentralized trial as one with elements that occur away from traditional sites, such as telehealth and home visits. Atopic dermatitis is assessed partly by clinician-rated skin signs, which makes remote assessment a real question.
| Seat | What it is asked | What it works from |
|---|---|---|
| Clinical Operations Director | Whether recruitment, retention and workload favor a decentralized or hybrid design.1 | Site and vendor experience. |
| Regulatory Strategist | Whether regulators will accept remote assessment of the primary endpoint.1,2 | FDA guidance and the European recommendation paper. |
| Director Quality Assurance | How data integrity, oversight and investigational product handling are controlled off site.3 | ICH E6(R3) and Annex 2. |
| Head of Digital Therapeutics | Whether remote tools can capture the endpoint reliably. | Validation data for remote assessment. |
What the review does
The endpoint decides what can move. A clinician-rated skin score taken by video differs from one taken in person. The review shows which seat sees that as an evidence problem and which as an assumption to test.1
The standard has changed. ICH E6(R3) adds an annex on decentralised elements. The quality seat sets out what the annex implies for oversight.3
What would settle it. A feasibility pilot of remote assessment against in-person scoring, and the design decision it 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:
- Remote scoring agrees closely with in-person scoring for this endpoint.
- The regions in the trial accept decentralized elements.
- Participants will keep to home visits and device use.
Standards, guidance and sources
Frame
The decision practice behind the memo itself is on the template page.
What gets flagged
Any claim that remote scoring is equivalent without data, any region whose rules were not checked, and any seat that treats all elements as equally movable.
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 select vendors or write the protocol.
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. Conducting Clinical Trials With Decentralized Elements. Final guidance, September 2024. Definition as given in FDA’s announcement; the text was not read in full.
- [2] European Medicines Agency and ACT EU. Recommendation paper on the use of decentralised elements in clinical trials. December 2022. Known from EMA’s news page; check for a newer version.
- [3] International Council for Harmonisation. ICH E6(R3): Guideline for good clinical practice, including Annex 2. Dates as given in listings; EU effective dates differ between EMA pages.
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.