The European Unions’ Clinical Trials Directive

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. Directive 2001/20/EC. Offic J Eur Commun, 1 May 2001: 0034–0044

Kmietowicz Z. EU Directive on clinical trials will cost lives. Biomed Central 23 October 2000 [www.biomedcentral.com]

Anon. New directive for clinical research will have huge impact on pharmacists. Pharm J 2001; 267: 3–8

Anon. Red tape threatens research. BBC News 16 October 2000 [www.bbc.co.uk]

Watson R. New rules might hinder research. BMJ 2001; 322: 385

Earl-Slater A. Handbook of Clinical Trials, Research Governance and other Research. Abingdon: Radcliffe Medical Press (in press)

European Science Foundation. Co-ordination of public funding for European Clinical Trials. Eur Sci Found Policy Briefing 2 May 2001

European Science Foundation. Harmonisation of clinical trials: administrative constraints. Eur Sci Found Policy Briefing 2 May 2001

Joint Pharmaceutical Analysis Group. Implications of the new clinical trials directive. Pharm J 2001; 267: 26–7