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. 2017 Jul 10;7(7):e015579.
doi: 10.1136/bmjopen-2016-015579.

Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities

Affiliations

Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities

Tilde Dombernowsky et al. BMJ Open. .

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.

Keywords: CLINICAL PHARMACOLOGY; Clinical trials; PUBLIC HEALTH.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
The summarised number of clinical trial applications in 10 Western European countries. The 10 included countries are Germany, Italy, Spain, France, the UK, Belgium, the Netherlands, Austria, Denmark and Sweden. The summarised number of clinical trial applications for 2015 is estimated as data from Italy regarding 2015 is not yet available from the national competent authorities. The number of clinical trials authorised in Italy in 2015 is therefore estimated.
Figure 2a
Figure 2a
The total number of clinical trial applications in 10 Western European countries. AAGRs, average annual growth rates. Data from Italy, France and Spain refer to the numbers of authorised clinical trials and not clinical trial applications. The AAGRs, R2s and p values are based on linear regression lines (not shown).
Figure 2b
Figure 2b
The number of commercially sponsored clinical trial applications in 10 Western European countries. AAGRs, average annual growth rates. Data from Italy, France and Spain refer to the numbers of authorised clinical trials and not clinical trial applications. The national competent authorities of France states that approximately two-thirds of the clinical trials authorised annually in France are commercially sponsored, and one-third is non-commercially sponsored. The exact number of clinical trials by type of sponsor is unknown. The AAGRs, R2s and p values are based on linear regression lines (not shown).
Figure 2c
Figure 2c
The number of non-commercially sponsored clinical trial applications in 10 Western European countries. AAGRs, average annual growth rates. Data from Italy, France and Spain refer to the numbers of authorised clinical trials and not clinical trial applications. The national competent authorities of France states that approximately two-thirds of the clinical trials authorised annually in France are commercially sponsored, and one-third is non-commercially sponsored. The exact number of clinical trials by type of sponsor is unknown. The AAGRs, R2s and p values are based on linear regression lines (not shown).
Figure 3
Figure 3
The average annually number of clinical trial applications by trial phase in nine Western European countries. The average annually number of clinical trial applications is based on data from 2007 to 2015. Phases can overlap. Thus, the summarised number of clinical trial applications for all trial phases is not necessarily equal to the total number of clinical trial applications registered. In the UK, phase II and III clinical trials are registered together and could therefore not be separated. The average number of clinical trial applications for phase II and III in the UK is 590. Data from Denmark regarding the number of clinical trial applications by trial phase are only from 2010 to 2015. Data from Italy and Spain refer to the numbers of authorised clinical trials and not clinical trial applications.

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