Evidence map›Paper›PMID 36034814›Full record

SynthesisFrontiers in pharmacology2022

Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.

Frauke Naumann-Winter, Franziska Wolter, Ulrike Hermes, Eva Malikova, Nils Lilienthal, Tania Meier, Maria Elisabeth Kalland, Armando Magrelli

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Frontiers in pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
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

8 authors.

Frauke Naumann-WinterFederal Institute for Drugs and Medical Devices, Bonn, Germany.
Franziska WolterFederal Institute for Drugs and Medical Devices, Bonn, Germany.
Ulrike HermesFederal Institute for Drugs and Medical Devices, Bonn, Germany.
Eva MalikovaDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, Comenius University, Bratislava, Slovakia.
Nils LilienthalFederal Institute for Drugs and Medical Devices, Bonn, Germany.
Tania MeierFederal Institute for Drugs and Medical Devices, Bonn, Germany.
Maria Elisabeth KallandNorwegian Medicines Agency, Oslo, Norway.
Armando MagrelliNational Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

drug developmentefficacymarketing authorization applicationorphan drugsorphan medicinal productreal-world data

Identifiers

PMID36034814
PMCPMC9413272

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.