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Abstract
Objective To 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.
Design Registry study.
Setting Data from national competent authorities.
Participants Germany, 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.
Results From 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.
Conclusions This 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.
- CLINICAL PHARMACOLOGY
- Clinical trials
- PUBLIC HEALTH
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Footnotes
Contributors TD, MH, UL and SFT designed the study. TD collected the data and developed the first draft of the manuscript. MH, UL and SFT contributed to the critical revision of the data and results and revised the manuscript. The final version of the manuscript is approved by all authors. TD is the guarantor.
Funding This study is funded by a research grant from The Capital Region of Denmark. The funder was not involved in the research, preparation or writing of this article, nor in the decision to submit it for publication.
Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work other than those mentioned in the funding statement; MH reports research grants from private companies as stated in the disclosure form; these are not related to the submitted work; no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement An overview of data sources is available as a supplemental file (appendix 1). Data are available from the corresponding author on request at dombernowsky@gmail.com.