Panel · Use case · Medical Affairs

Label Expansion Round Table.

LiveRound Table

Convene real-world evidence, regulatory, HEOR and safety leads on whether to pursue a new indication using real-world evidence.

DecisionPursue a new indication with real-world evidence, or not

DisciplinesReal-world evidence, regulatory, HEOR, safety

ReaderMedical affairs leads

Not askedA study protocol

DepthStandard, four seats

Label Expansion Round Table is a ready-made use case for Medical Affairs. It ships under the Round Table template.

For medical affairs leads. 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 company pursue a new indication for a marketed medicine using real-world evidence?

Who is at the table

Real-world evidence can support some regulatory decisions, but the agencies ask for data that are fit for the question. The panel starts from what they have published about that.

Seat	What it is asked	What it works from
Global Real-World Evidence Lead	Whether available data can answer the question and with what design.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products: guidance for industry. August 2023.,3European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}	FDA’s considerations for real-world data and evidence, and the HMA-EMA catalogue.
Regulatory Strategist	Whether an agency would accept the evidence for a label change and how to engage early.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products: guidance for industry. August 2023.,2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}	FDA’s and EMA’s published expectations.
HEOR Evidence Lead	Whether payers will accept the same evidence and what they would add.^{4National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). 2022.}	The NICE real-world evidence framework.
Head of Pharmacovigilance	Whether use in a new population changes the safety profile and what monitoring is needed.	Safety data from the marketed product.

What the round table does

Fit for purpose is the sponsor’s case. EMA’s reflection paper puts the burden on the applicant to justify that real-world data are appropriate for a regulatory decision. The panel lists what that case would have to show.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

Regulators and payers ask different questions. A regulator asks whether the evidence supports the label; a payer asks whether it supports value. The panel keeps the two apart.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.,4National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). 2022.}

Existing data may already exist. The European catalogue lists real-world sources by data holder and type. The panel notes which may fit and that the catalogue holds metadata only.^{3European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}

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 population for the new indication is captured in the available data.
The agency will accept a non-interventional design for this question.
The comparator can be defined without randomization.

Standards, guidance and sources

Guidance

FDA, Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.^{1U.S. Food and Drug Administration. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products: guidance for industry. August 2023.}
EMA, reflection paper on real-world data in non-interventional studies, final, 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.}
HMA-EMA catalogues of real-world data sources and studies.^{3European Medicines Agency and Heads of Medicines Agencies. HMA-EMA catalogues of real-world data sources and studies.}
NICE real-world evidence framework.^{4National 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 claim that an agency has accepted real-world evidence for a similar change, any data source not confirmed as available, and any design that cannot define its comparator.

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 design the study or give a regulatory commitment.

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. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products: guidance for industry. August 2023. Title and date as known from FDA’s listing; not read in full.
[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] 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.
[4] 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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