ArticlePLoS medicine2013
A new approach to psychiatric drug approval in Europe.
Article in PLoS medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled 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.
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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Is the efficacy of antidepressants in panic disorder mediated by adverse events? A mediational analysis.PloS one · 2017Pooled it
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- Ground-breaking change to the mental health section of the WHO Model List of Essential Medicines: implications for low- and middle-income countries.Epidemiology and psychiatric sciences · 2024Article
- EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.Epidemiology and psychiatric sciences · 2021Article
- Public health psychopharmacology: a new research discipline comes of age?Epidemiology and psychiatric sciences · 2018Article
- Mapping actions to improve access to medicines for mental disorders in low and middle income countries.Epidemiology and psychiatric sciences · 2017Article
- Every effect size has its place: a commentary on the avoidance of pre-post effect sizes.Epidemiology and psychiatric sciences · 2017Article
- Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers.Addiction (Abingdon, England) · 2016Review
- Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis.Investigational new drugs · 2016Article
- Access and use of psychotropic medicines in low-resource settings.Epidemiology and psychiatric sciences · 2015Article
- Ethical considerations in placebo-controlled randomised clinical trials.BJPsych open · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Corrado Barbui and Irene Bighelli question the current rules governing registration of new medicines in Europe, using the example of psychiatric drugs, and argue that the concept of absolute efficacy should be replaced by the concept of added value whereby evidence from studies comparing a new product with an active comparator should guide the drug approval process. Please see later in the article for the Editors' Summary.
Indexed as
Identifiers
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.