Panel · Use case · Medical Affairs

Post-Marketing Study Triage.

LivePrioritisation Panel

Which of these 13 proposed post-marketing studies should we fund first?

Items13 proposed post-marketing studies

SeatsReal-world evidence, medical, safety, operations

ReaderEvidence and safety leads

Not askedStudy protocols

DepthStandard, four seats

Post-Marketing Study Triage is a ready-made use case for Medical Affairs. It ships under the Prioritisation Panel template.

For medical affairs leads. You get each seat's ranking, the aggregated list with a cut line, where the seats disagree and how stable the line is. 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

Which of these 13 proposed post-marketing studies should we fund first?

Who ranks

Some post-marketing studies are required by regulators, and others are chosen by the company. The panel ranks both against their value and the effort needed.

Seat	What it ranks from	Why it is at the table
Global Real-World Evidence Lead	Which studies the available data can answer reliably.^{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 EMA reflection paper on real-world data.
Global Medical Affairs Director	Which studies answer questions that clinicians and guidelines are waiting on.	Guidelines.
Head of Pharmacovigilance	Which studies address open safety questions or regulatory commitments.^{1U.S. Food and Drug Administration. Postmarketing Requirements and Commitments.}	FDA postmarketing requirements.
Clinical Operations Director	Which studies are feasible and how long they take.	Operational feasibility.

What the run does

Required studies come first. A required study with a due date is not ranked against optional ones on value alone. The report separates commitments from choices.^{1U.S. Food and Drug Administration. Postmarketing Requirements and Commitments.}

Value versus effort. Optional studies are placed by the value of the answer and the effort and time to get it.^{2European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025.}

Sensitivity. The report shows how the order changes if the weight on safety questions rises.

Recommended length

Standard

Four angles weigh the list differently. Standard depth gives each a seat, with disagreement, value versus effort and sensitivity, in about four pages.

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

Assumptions the run makes

The run states the assumptions behind its criteria and its cut line, and says what each gap limits. Examples for this list:

The studies are independent and can be funded in any order.
The effort estimates are comparable across studies.
Required studies are identified correctly.

Standards, guidance and sources

Frame

FDA, postmarketing requirements and commitments.^{1U.S. Food and Drug Administration. Postmarketing Requirements and Commitments.}
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.}

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

What gets flagged

Any study with a regulatory due date ranked as optional, any effort estimate not supplied by operations, and any study on which seats split widely.

What arrives

The question, criteria and items
The cut line and the top group
How each seat ranked
The aggregated ranking
Where the seats disagree
Value versus effort
Sensitivity of the cut line
Limits and what would change the ranking

What it will not do

The agreement is a simulation by AI specialists and not a panel of real experts. The criteria are fixed before ranking, and the cut line is a recommendation that the decider can move.

It does not decide which studies are required.

It is a simulation by AI specialists and not a panel of real experts. Seats that share a base model are not independent confirmations of each other.

It does not compute a value-of-information analysis. That needs a decision model. It ranks by proxies and says so.

It does not set the weights for you. If none are supplied, the criteria are weighted equally and the report says so.

References

[1] U.S. Food and Drug Administration. Postmarketing Requirements and Commitments. Known from FDA’s site; 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.

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.