New European clinical trials directive
http://www.100md.com
《英国医生杂志》
EDITOR—The European Union's clinical trials directive has been the focus of much attention in the clinical trials community, but it has had little attention, and certainly much less than it deserves, from the wider medical community.1 Woods's editorial clearly defines the current state of play with this new legislation and its potential impact on noncommercial or publicly funded research.2
Woods says that more research staff with better professional training and support may be needed in some publicly funded research. This is in fact an absolute necessity.
The draft statutory instrument that will transpose the EU directive into UK legislation lists more than 30 separate offences, with penalties ranging from a substantial fine to imprisonment.3 Since ignorance is no defence in law, from 1 May investigators will have to be aware of these new regulations.
Moreover, if NHS trusts and universities are to become sponsors, as laid out in the EU directive, they too must be aware of the wide portfolio of responsibilities that will accompany this role. What better way to achieve this than by providing timely and effective training programmes?
The scale of this task cannot be underestimated. Funding to develop training initiatives has not been readily forthcoming, and we, like other groups who have a leading role in this area, need support to facilitate the implementation process. As part of the better coordination called for by Woods between the major stakeholders (investigators, funders, universities, and NHS organisations), we recommend that funding for the development of training initiatives be put high on the agenda.
Allan Gaw, director
Allan.Gaw@ctunit.co.uk, Clinical Trials Unit, Glasgow Royal Infirmary, Glasgow G4 0SF
Moira M B Mungall, head of education
Clinical Trials Unit, Glasgow Royal Infirmary, Glasgow G4 0SF
Competing interests: AG and MMBM's clinical trials unit provides and develops training courses in good clinical practice and the conduct of clinical trials.
References
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.
Woods K. Implementing the European clinical trials directive. BMJ 2004;328: 240-1. (24 January.)
The medicines for human use (clinical trials) regulations 2003. www.mca.gov.uk/inforesources/publications/mlx287_draftreg.pdf (accessed 3 Feb 2004).
Woods says that more research staff with better professional training and support may be needed in some publicly funded research. This is in fact an absolute necessity.
The draft statutory instrument that will transpose the EU directive into UK legislation lists more than 30 separate offences, with penalties ranging from a substantial fine to imprisonment.3 Since ignorance is no defence in law, from 1 May investigators will have to be aware of these new regulations.
Moreover, if NHS trusts and universities are to become sponsors, as laid out in the EU directive, they too must be aware of the wide portfolio of responsibilities that will accompany this role. What better way to achieve this than by providing timely and effective training programmes?
The scale of this task cannot be underestimated. Funding to develop training initiatives has not been readily forthcoming, and we, like other groups who have a leading role in this area, need support to facilitate the implementation process. As part of the better coordination called for by Woods between the major stakeholders (investigators, funders, universities, and NHS organisations), we recommend that funding for the development of training initiatives be put high on the agenda.
Allan Gaw, director
Allan.Gaw@ctunit.co.uk, Clinical Trials Unit, Glasgow Royal Infirmary, Glasgow G4 0SF
Moira M B Mungall, head of education
Clinical Trials Unit, Glasgow Royal Infirmary, Glasgow G4 0SF
Competing interests: AG and MMBM's clinical trials unit provides and develops training courses in good clinical practice and the conduct of clinical trials.
References
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.
Woods K. Implementing the European clinical trials directive. BMJ 2004;328: 240-1. (24 January.)
The medicines for human use (clinical trials) regulations 2003. www.mca.gov.uk/inforesources/publications/mlx287_draftreg.pdf (accessed 3 Feb 2004).