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
Editorial
. 2004;6(4):145-7.
doi: 10.1186/bcr800. Epub 2004 Apr 20.

Breast cancer research and the European Union Clinical Trials Directive

Norman Williams  1
Affiliations
Editorial

Breast cancer research and the European Union Clinical Trials Directive

Norman Williams. Breast Cancer Res. 2004.

Abstract

Running clinical trials in the commercial sector has always been associated with a certain amount of bureaucracy due to the stringent requirements needed to bring a new drug onto the market. Noncommercial trials have largely been performed outside these requirements. New legislation brought about as a result of the implementation of the European Union Clinical Trials Directive will change this two-tiered approach by harmonizing regulations in all member states. Those who run noncommercial clinical trials will have to find cost-effective ways of dealing with this legislation if such work is to continue in Europe.

PubMed Disclaimer

References

    1. Williams NR, McRae K, Houghton J. Delays in ethics committee approval: an English perspective [abstract] Breast Cancer Res Treat. 2003;82(suppl 1):S80.
    1. The European Parliament and the Council of the European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 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 J Eur Communities. 2001;L121:34–44. - PubMed
    1. Baum M, Buchanan M, Baselga J, Cataliotti L, Jassem J, Piccart M. The future of breast cancer research in danger. Eur J Cancer. 2002;38:2210–2213. doi: 10.1016/S0959-8049(02)00482-3. - DOI - PubMed
    1. The ATAC (Arimidex, Tamoxifen Alone or in Combination) Trialists' Group Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of post-menopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359:2131–2139. doi: 10.1016/S0140-6736(02)09088-8. - DOI - PubMed
    1. Baum M. Background. In: Buzdar A, Baum M, editor. In History and Advancement of Anastrozole in the Treatment of Breast Cancer. London: The Royal Society of Medicine Press; 2003. pp. 3–6.

Publication types

MeSH terms