Panel · Use case · Regulatory

Regulator Meeting Rehearsal.

LiveStakeholder Rehearsal

Rehearse a pre-submission meeting on a novel endpoint with simulated regulator, statistician and clinician voices.

MeetingAn FDA pre-submission meeting on a novel clinical endpoint

ConstituenciesDivision lead, statistical reviewer, clinician, sponsor

ReaderRegulatory and development leads

Not askedA prediction of FDA’s answers

DepthStandard, four seats

Regulator Meeting Rehearsal is a ready-made use case for Regulatory. It ships under the Stakeholder Rehearsal template.

For regulatory leads. You get each simulated constituency's position, where they conflict, the objections with proposed responses and what each would need to move. The constituencies are simulated, not consulted. 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

How will a review division lead, a statistical reviewer, a clinician and the sponsor’s regulatory lead discuss a novel clinical endpoint at an FDA pre-submission meeting?

Who is simulated

FDA publishes guidance on formal meetings with sponsors and on how patient experience data and outcome measures should be developed. The seats are briefed on both.

Constituency simulated	What it is asked	What it works from
Review division lead	Whether the endpoint measures benefit that matters and fits the indication.^{2U.S. Food and Drug Administration. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making.}	FDA’s patient-focused drug development guidance series.
Statistical reviewer	Whether the endpoint can be analyzed reliably: missing data, multiplicity and estimand.^{3International Council for Harmonisation. ICH E9(R1): Addendum on estimands and sensitivity analysis in clinical trials.}	ICH E9(R1) on estimands.
Clinician	Whether the change the endpoint detects is meaningful to patients.	Clinical guidelines and patient input.
Sponsor’s regulatory lead	How to frame the questions, what to ask FDA and what to hold back.^{1U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}	FDA’s guidance on formal meetings.

What the rehearsal does

The questions are the product. The meeting is shaped by the questions the sponsor submits. The report lists the questions to ask and the answers that would change the program.^{1U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}

Measurement and meaning. A novel endpoint must be both reliable and meaningful. The report separates the objections about reliability from those about meaning.^{2U.S. Food and Drug Administration. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making.}

What a rehearsal cannot tell you. Agency staff may hold views the public record does not show. The simulation draws only on published guidance.

Recommended length

Standard

Four constituencies are in the room. Standard depth gives each a seat and ends with what a rehearsal cannot tell you, in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the rehearsal checks

The rehearsal states the assumptions it makes about each constituency, and says what each gap limits. Examples for this meeting:

The endpoint has qualification or precedent that the division will recognize.
The estimand is specified before the meeting.
The sponsor has natural history data to anchor the meaning of change.

Standards, guidance and sources

Frame

FDA, formal meetings between FDA and sponsors or applicants of PDUFA products.^{1U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}
FDA, patient-focused drug development guidance series.^{2U.S. Food and Drug Administration. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making.}
ICH E9(R1), addendum on estimands and sensitivity analysis.^{3International Council for Harmonisation. ICH E9(R1): Addendum on estimands and sensitivity analysis in clinical trials.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any statement attributed to an agency reviewer, any question the sponsor would not want answered in writing, and any endpoint property not backed by data.

What arrives

The question put, and who was simulated
The stakeholder map
Each constituency's position
Where they conflict
Objections and responses
What each would need to move, and the order to engage
What a rehearsal cannot tell you

What it will not do

The constituencies are simulated by AI specialists and are not the real people. The rehearsal prepares you for objections you can anticipate and does not predict the live room.

It does not predict FDA’s response or replace the meeting package.

It is not research with real stakeholders. The constituencies are simulated by AI specialists from stated sources, and they are not the real people.

It does not predict what the live room will say. It prepares you for the objections you can anticipate.

It does not script a response to be repeated. The responses are for you to test and to adapt.

References

[1] U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry. Title known from FDA’s guidance listing; its current version was not checked.
[2] U.S. Food and Drug Administration. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making. Known from FDA’s site; not read in full.
[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.