ArticleFrontiers in pharmacology2024
Identifying and overcoming challenges in the EMA's qualification of novel methodologies: a two-year review.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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.
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.
Who cites it
4 citing papers in PubMed.
- Detection and quantification of ezetimibe and its major glucuronide in patients with hepatic impairment via liquid chromatography-tandem mass spectrometry.Journal of pharmaceutical and biomedical analysis · 2026Article
- Filling the mechanistic and methodological gaps for predicting cytokine release syndrome in humans.Frontiers in pharmacology · 2026Article
- Application of the research domain criteria in early-phase clinical development of transdiagnostic neurotherapeutics: A multidisciplinary perspective.Neuroscience applied · 2026Review
- High hopes? Precision psychedelic addiction medicine.Frontiers in psychiatry · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The EMA Qualification of Novel Methodologies procedure qualifies methods, technologies and methodologies within a well-defined context of use in a pharma R&D context based on the evaluation of the presented scientific rationale and submitted data. This policy brief analyses QoNM submissions providing policy messages and recommendations to stakeholders on how to better prepare qualification applications in this regard. The recommendations include: 1. Grounding validation strategy using a current standard measure or a distribution technique. 2. Accurately represent pertinent subgroups via accurate inclusion and exclusion criteria. 3. Establish a well-defined and specific CoU with clear descriptions of the use within a development program target population and disease stage. Lastly, it emphasizes role of the QoNM procedure in advancing medicine development methodologies within the EU.
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What OpenQuestion holds
Registered trials
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.