ArticleBMJ open2017
Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities.
Article in BMJ open, 2017. 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, 13 citations in OpenAlex.
- Clinical trials on medicinal products in the EU/EEA, 2013-2025: a cross-sectional analysis of CTIS and EudraCT data.The Lancet regional health. Europe · 2026Article
- Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.Reviews on recent clinical trials · 2023Article
- Article
- Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study.Clinical trials (London, England) · 2022Article
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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the development in the number of applications for authorisation of clinical trials of medicines (CTAs) submitted annually to national competent authorities in 10 Western European member states of the European Union from 2007 to 2015.
designRegistry study.
settingData from national competent authorities.
participantsGermany, Italy, Spain, France, the UK, Belgium, the Netherlands, Austria, Denmark and Sweden. Inclusion criteria were Western European member states of the European Union, receiving more than 200 CTAs per year. OUTCOME MEASURES: Summarised number of CTAs and distribution of CTAs by type of sponsor (commercial or non-commercial) and trial phase (I-IV). Average annual growth rates (AAGRs) based on linear regressions. Data were evaluated 2007-2011 and 2012-2015 to compare findings with the European Commission's statement of a 25% decrease in CTAs in the EU from 2007 to 2011.
resultsFrom 2007 to 2011, the summarised number of CTAs decreased significantly (AAGR -3.9% (p=0.02)), primarily due to a decrease in commercially sponsored CTAs. From 2012 to 2015, the change was insignificant (AAGR 2.6% (p=0.27)), however with a 10% increase from 2014 to 2015 after stagnation from 2012 to 2014. Overall, the number of CTAs and distribution by type of sponsor varied considerably between countries. No distinct trends were observed when evaluating CTAs by type of trial phase.
conclusionsThis study found a significant decrease in the number of CTAs in Western Europe from 2007 to 2011 (AAGR -3.9%). This development is possibly attributable to several factors such as the European Clinical Trials Directive, national and local political decisions, and a potential global shift in clinical trial activity. From 2014 to 2015, the number of CTAs increased markedly (10%). However, it is yet too soon to determine if this constitutes a transient fluctuation or a new trend.
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.