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

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 measuresSummarised 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.

Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study

“…Interpretation of our work is informed by prior studies examining clinical trial applications to major European national regulators using data directly from the regulators rather than the EUCTR. 47 – 49 These show generally consistent trends in new applications over time. Perturbation in some trends, such as a decrease in new applications in Germany between 2009 and 2013, is mirrored in the EUCTR ( Supplemental Figure 3 : Germany – Bundesinstitut für Arzneimittel und Medizinprodukte); however, major deviations did not match.…”

“…These studies consistently reported that France received between ∼700 and 1200 trial applications a year which is not aligned with EUCTR data. 48 Dombernowsky and colleagues reported >800 trial applications per year to the French regulator in 2013 and 2014, while the EUCTR only contained 215 French protocols across both years. Another analysis in Nordic countries shows Sweden and Denmark broadly matched the EUCTR in the quantity of new applications (∼200–300 applications/year); however, between 400 and 500 applications were reported in Norway from 2004 to 2006, yet only 76 Norwegian protocols exist on the EUCTR for those years.…”

Panorama de pesquisas com seres humanos sobre covid-19 no Brasil

“…A multinational study involving Germany, Italy, Spain, France, the United Kingdom, Belgium, the Netherlands, Austria, Denmark, and Sweden showed that each of these countries receives more than 200 clinical trials of drugs per year, mainly in Phase III 50 . The fluctuations over the years were attributed to political influences and commercial sponsorship in Western Europe, with a 4% decrease in proposals between 2007 and 2011, stagnation between 2012 and 2013, and an 10% increase between 2014 and 2015 50 . In Switzerland, randomized clinical trials cost, on average, US$ 72,000, with different approval intervals when comparing research ethics committees (from 82 to 92 days) and the Swissmedic regulatory agency (27 to 49 days) 36 .…”

Clinical trials challenges - impact of the new clinical trial regulation on the conduct of clinical trials

“…In Europe, the largest number of clinical trials is conducted in Western European countries and the total number of applications for authorization of clinical trials of medicines (CTAs) across Europe decreased by 25% in the period from 2007 to 2011 1 . This allowed for linking the issue to the potentially problematic provisions of the current EU Clinical Trial Directive No 2001/20/EC 2,3 .…”