Evidence map›Paper›PMID 40708647›Full record

ArticleFrontiers in medicine2025

Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU-summary of a Focus group discussion.

Stiina Aarum, Claudia Popp, Alexa Hunter, Miha Skvarc, Ilona Reischl, Hilke Zander, Joerg Zinserling, Petra van Leeuwen, Jonathan Sutch, Tim Chesworth and 6 more

Abstract read
In one paragraph

Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Stiina AarumEuropean Medicines Agency, Amsterdam, Netherlands.
Claudia PoppF. Hoffmann-La Roche Ltd., Drug Regulatory Affairs, Basel, Switzerland.
Alexa HunterMerck KGaA, Darmstadt, Germany.
Miha SkvarcEuropean Medicines Agency, Amsterdam, Netherlands.
Ilona ReischlAustrian Medicines and Medical Devices Agency (AGES MEA), Vienna, Austria.
Hilke ZanderPaul-Ehrlich-Institut, Langen, Germany.
Joerg ZinserlingBiostatistics and Special Pharmacokinetics Unit, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) (Federal Institute for Drugs and Medical Devices), Bonn, Germany.
Petra van LeeuwenTeam-NB, DEKRA Certification B.V., Arnhem, Netherlands.
Jonathan SutchTeam-NB, BSI, Milton Keynes, United Kingdom.
Tim ChesworthAstraZeneca ORSSE, CMC Regulatory Affairs, Macclesfield, United Kingdom.
Elisabeth KapellerSandoz GmbH, Kundl, Austria.
Andreas EmmendoerfferF. Hoffmann-La Roche Ltd., Pharma Technical Regulatory, Basel, Switzerland.
Iordanis GravanisEuropean Medicines Agency, Amsterdam, Netherlands.
Christelle BouyguesEuropean Medicines Agency, Amsterdam, Netherlands.
Claudia VincenziEuropean Medicines Agency, Amsterdam, Netherlands.
Michael BerntgenEuropean Medicines Agency, Amsterdam, Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although there is growing use of medicinal products in combination with medical devices, including

Indexed as

advicecombination productsdevelopmentdevicesinnovationIVDMedicines

Identifiers

PMID40708647
PMCPMC12287061

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.