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
. 2009 Nov;3(11):e1000131.
doi: 10.1371/journal.pmed.1000131. Epub 2009 Nov 17.

The unintended consequences of clinical trials regulations

Alex D McMahon  1 , David I Conway, Tom M Macdonald, Gordon T McInnes
Affiliations

The unintended consequences of clinical trials regulations

Alex D McMahon et al. PLoS Med. 2009 Nov.

Abstract

Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

References

    1. Stewart PM, Stears A, Tomlinson JW, Brown MJ. Regulation – the real threat to clinical research. BMJ. 2008;337:1085–1087. - PubMed
    1. ICH Good Clinical Practice CPMP/ICH/135/95. 2002 Available: http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf. Accessed 6 July 2009.
    1. Baum M, Buchanan M, Baselga J, Cataliotti L, Jassem J, et al. The future of breast cancer research in danger. Eur J Can. 2007;38:2210–2213. - PubMed
    1. Directive 2001/20/ EC of the European parliament and of the council of 4 April 2002 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities. 2001;L121:34–44. Available: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_2.... Accessed 6 July 2009. - PubMed
    1. The Medicines for Human Use (Clinical Trials) Regulations 2004. 2004 Available: http://www.opsi.gov.uk/si/si2004/20041031.htm. Accessed 6 July 2009. - PubMed

MeSH terms