Panel · Use case · Market Access

Evidence Generation Spend Board.

LiveGo / No-Go Board

Is this real-world evidence study worth its budget, or should we fund a smaller design or stop?

DecisionFund the study, fund a smaller design, or stop

LensesHEOR, real-world evidence, evidence, access

ReaderEvidence and access leadership

Not askedA protocol

DepthStandard, four seats

Evidence Generation Spend Board is a ready-made use case for Market Access. It ships under the Go / No-Go Board template.

For market access 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

Is this real-world evidence study worth its budget, or should we fund a smaller design or stop?

Who scores

An evidence study is worth its cost if it can change a decision. The board scores what the study could show and who would act on it.

Seat	What it scores	What it works from
HEOR Evidence Lead	Whether the study answers a question payers or assessors will ask.^{3National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). 2022.}	Assessment frameworks such as NICE’s.
Global Real-World Evidence Lead	Whether the data and design can answer the question without avoidable bias.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.,2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}	The HMA-EMA catalogue and the EMA reflection paper.
Global Value & Evidence Lead	How much the result would move the certainty of the evidence base.	Evidence grading methods.
Global Market Access Director	Whether a favorable result would change a decision in a market that matters.	Payer decisions.

What the board does

Would the answer change the decision? The board scores the study on the decision it could change. If no plausible result would change what any payer or regulator does, that is a finding.

Smaller designs are options. The recommendation can be to fund a feasibility analysis first, with a gate before the larger budget.

Fit for purpose. The data seat scores whether the proposed source captures the outcome and the confounders, as the reflection paper requires the applicant to show.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.,2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

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 data source is available to license on acceptable terms.
The sample is large enough to detect a meaningful difference.
Assessors will accept real-world evidence for this question.

Standards, guidance and sources

Frame

HMA-EMA catalogues of real-world data sources and studies.^{1European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}
EMA, reflection paper on real-world data in non-interventional studies, 2025.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}
NICE real-world evidence framework.^{3National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). 2022.}

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

What gets flagged

Any budget figure not supplied by the sponsor, any data source not confirmed as available, and any benefit that depends on a single payer.

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 study or set its budget.

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] European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies. Known from EMA’s news page; the catalogues were not searched.
[2] European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025. Status as given in EMA’s listing; not read in full.
[3] National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). 2022. Known from NICE’s 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.

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