Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2006 Jun;1(2):e13.
doi: 10.1371/journal.pctr.0010013.

The clinical trials directive: how is it affecting Europe's noncommercial research?

Markus Hartmann  1 , Florence Hartmann-Vareilles
Affiliations

The clinical trials directive: how is it affecting Europe's noncommercial research?

Markus Hartmann et al. PLoS Clin Trials. 2006 Jun.
No abstract available

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors declare that no competing interests exist.

Figures

Figure 1
Figure 1. Schematic Presentation of Differences in the Scope of National Laws Governing Clinical Trials in Europe
Legislative acts in each member state were recently revised to cope with the requirements of the CTD 2001/20/EC. Shadowed boxes indicate revised legislation in response to the Directive. The German ordinance on irradiation protection (Strahlenschutzverordnung) and the Italian decree on clinical research for the improvement of clinical practice (Decreto 17 Dec 04) constitute two accompanying legal acts. The term multi-modal therapy trials refers to trials that evaluate the effects of drug therapy together with other forms of medical intervention, e.g., irradiation, surgery, other procedures.
Figure 2
Figure 2. Comparison of the EU CTA and the US IND Application Procedures
For noncommercial, patient-focused research, supplemental guidelines were issued in the US, whereas in the EU, exemptions from the clinical trial application (CTA) process and applicable GCP principles are restricted to post-authorisation safety studies. Observational studies using epidemiological methods are generally exempted from regulation in the EU and US.
See this image and copyright information in PMC

References

    1. European Parliament and Council of the European Union. Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001. OJ L 121: 34–44; 2001. Available: http://eudract.emea.eu.int/docs/Dir2001-20_en.pdf. Accessed 25 May 2006.
    1. Moulton B. Save European research campaign. BMJ. 2004;328:286. - PMC - PubMed
    1. Demotes-Mainard J, Ohmann C. European Clinical Research Infrastructures Network: Promoting harmonisation and quality in European clinical research. Lancet. 2005;365:107–108. - PubMed
    1. European Society of Cardiology. Does the EU help or hinder trials? CRT Task Force 5 Opinion Poll from 31/05/2005 on EU Clinical Trials Directive 2001/20/EC. Sep (4, 2005). Available: http://www.escardio.org/initiatives/News/events/esc_congress/Does-EU-Hel.... Accessed 30 May 2006.
    1. Federation of European Cancer Societies. The Clinical Trials Directive. Summary on results of FECS survey from 26 May 2005. 2005. Available: http://www.fecs.be/emc.asp?pageId=1090. Accessed 30 May 2006.