Panel · Use case · Clinical Operations
Trial Eligibility Round Table.
LiveRound TableConvene clinical operations, regulatory, safety and evidence on whether to widen the eligibility criteria of a Phase 3 trial that is behind on enrollment.
Trial Eligibility Round Table is a ready-made use case for Clinical Operations. It ships under the Round Table template.
For clinical operations leads weighing a protocol amendment. You get each discipline's view in its own terms, where they connect and disagree, what none covered and what the deliberation does not settle. 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 the eligibility criteria of a Phase 3 trial in moderate-to-severe atopic dermatitis that is behind on enrollment be widened?
Who is at the table
FDA’s guidance on eligibility criteria encourages sponsors to ask whether criteria are needed, and whether broadening them would help the trial represent the people who will use the medicine.
| Seat | What it is asked | What it works from |
|---|---|---|
| Clinical Operations Director | How much a wider population would speed enrollment, and what it does to site workload and monitoring. | Site feasibility and enrollment data. |
| Regulatory Strategist | Whether a protocol amendment needs agency review and how the change affects the analysis plan.1,2 | FDA guidance on eligibility and ICH E8(R1). |
| Head of Pharmacovigilance | Whether the added patients carry new safety risks and how they would be monitored. | Safety data for the class and the label. |
| Global Value & Evidence Lead | Whether the wider population still answers the payer questions and how it changes the estimand.3 | The trial’s estimand and comparator evidence. |
What the round table does
Widening can serve two aims. It can speed enrollment and make the trial more representative. The panel separates the two and says which one the evidence supports.1
A change in who is enrolled is a change in what is estimated. The evidence seat checks the amended population against the trial’s stated question, using the estimand framework.3
Timing matters. The panel states what an amendment would delay and what it would save, and marks any figure the sponsor has not supplied.
Recommended length
Standard
Four disciplines bear on this question. Standard depth gives each a seat, with the table of connections and the dissent, in about four pages.
You can pick another length on the form. The other two stay available.
Assumptions the round table checks
The round table states the assumptions each seat relies on, and says what each gap limits. Examples for this question:
- The slow enrollment is caused by the criteria and not by site activation or competition.
- The patients added would have a similar response to those already enrolled.
- The agency will accept the amendment without a new study.
Standards, guidance and sources
Guidance
The decision practice behind the memo itself is on the template page.
What gets flagged
Any enrollment figure not supplied by the sponsor, any safety claim not tied to class data, and any seat that treats the criteria as the only cause of slow enrollment.
What arrives
- The question, and who was asked
- Where the panel lands
- What each discipline says
- Where the disciplines connect
- Where they disagree, and why it matters
- What none of them covered
- What changes, and what this does not cover
What it will not do
It is a deliberation of AI specialists and not a vote of human experts. It reports where they land and where they split, and the decision stays with you.
It does not amend the protocol or advise on a submission.
It is not a vote of human experts. Every seat is an AI specialist, and the report says so.
It does not add a seat that did not speak or invent a quote or a number.
It does not decide. It sets out the views, the dissent and the gaps for you to decide.
References
- [1] U.S. Food and Drug Administration. Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: guidance for industry. November 2020. Title and date from FDA’s guidance listing as known; the guidance was not read.
- [2] International Council for Harmonisation. ICH E8(R1): General considerations for clinical studies. Not read.
- [3] International Council for Harmonisation. ICH E9(R1): Addendum on estimands and sensitivity analysis in clinical trials. Not read.
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.