Panel · Use case · Clinical Operations

Phase 2 to Phase 3 Transition Board.

LiveGo / No-Go Board

Does the Phase 2 data package meet our bar to commit to a Phase 3 program, and on what conditions?

DecisionCommit to Phase 3, hold, or stop

LensesOperations, regulatory, medical, evidence

ReaderDevelopment leadership

Not askedA Phase 3 design

DepthStandard, four seats

Phase 2 to Phase 3 Transition Board is a ready-made use case for Clinical Operations. It ships under the Go / No-Go Board template.

For clinical operations leads. You get a recommendation, the score matrix and vote tally, the conditions of approval and the dissent record. 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

Does the Phase 2 data package meet our bar to commit to a Phase 3 program, and on what conditions?

Who scores

A Phase 2 to Phase 3 gate is the most expensive commitment in the program. Go and no-go criteria are agreed benchmarks, and a data package is read against both a statistical bar and a clinical bar.

Seat	What it scores	What it works from
Clinical Operations Director	Whether a Phase 3 is feasible on the timeline and budget.	Site and enrollment data.
VP Global Regulatory Strategy	Whether the data and the endpoint would support a filing.^{2U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}	Agency guidance and meeting minutes.
Global Medical Affairs Director	Whether the effect is clinically meaningful and the unmet need is real.	Guidelines and clinical context.
Global Value & Evidence Lead	Whether the effect is large and certain enough, and what comparators say.^{1EUPATI Toolbox. Criteria for go/no-go decisions.}	The data package and comparator evidence.

What the board does

Two bars, three zones. The board reads the data against a statistical bar and a clinically meaningful bar set in advance. Clearing both is go, clearing neither is no-go, and clearing one is a consider zone that triggers conditions.^{1EUPATI Toolbox. Criteria for go/no-go decisions.}

Must-meet criteria cannot be averaged away. A failed safety or regulatory minimum is reported as failed, whatever the score elsewhere.

Conditions are specific. Each condition has an owner, a trigger and a consequence if unmet, for example revert to hold.^{2U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}

Recommended length

Standard

Four lenses bear on this decision. Standard depth gives each a seat, with the criteria, the matrix and the conditions in about four pages.

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

Assumptions the board scores against

The board states the assumptions behind its criteria and says what each gap limits. Examples for this decision:

The Phase 2 population represents the Phase 3 population.
The effect size is stable and not a chance finding.
The agency will accept the endpoint for approval.

Standards, guidance and sources

Frame

EUPATI Toolbox, criteria for go/no-go decisions.^{1EUPATI Toolbox. Criteria for go/no-go decisions.}
FDA, formal meetings between FDA and sponsors of PDUFA products.^{2U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products: guidance for industry.}

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

What gets flagged

Any threshold the board set without the decider, any criterion with no basis, and any score that spread widely across seats.

What arrives

The proposal and the decision sought
Board recommendation
Criteria and scoring basis
Seat assessments
Score matrix and vote tally
Conditions of approval
Pre-mortem and rebuttal outcome
Dissent and what would reverse the call

What it will not do

The decision belongs to the named decider and the seats are AI specialists. The thresholds are set by the proposer or the decider, and the board does not invent them.

It does not design the Phase 3 program.

It does not decide. The decision belongs to the named human decider, and the seats are AI specialists.

It does not set thresholds or weights for you. The proposer or the decider sets them.

It does not average away a failed must-meet criterion.

References

[1] EUPATI Toolbox. Criteria for go/no-go decisions. Read in the template research.
[2] 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 listing; the current version was not checked.

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.