Clinical trials internet resource
November 2004
Regulation and guidance on conducting clinical trials
Prior to testing on humans in clinical trials, new drugs are subject to rigorous testing in the laboratory (pre-clinical trials) for which animals are used. Research using animals is essential to produce sufficient evidence of efficacy and safety before proceeding to trials involving humans. Alternatives, such as computer modelling, and in vitro techniques have helped to substantially reduce the number of live animals needed for pre-clinical trials in recent years. All animal research must show that it minimises potential suffering in the research animals. It is strictly controlled and licensed under the Animals (Scientific Procedures) Act 1986 - read more here. The MRC produces a useful information leaflet on animal research. The medicines section of the Medicines and Healthcare products Regulatory Agency (MHRA) stringently scrutinises and adjudicates on the results from pre-clinical trials before the experimental drug can be tried in humans.
On 1 May 2004, The Medicines for Human Use (Clinical Trials) Regulations 2004 - read more here, came into force in the UK to better protect the rights, safety and well-being of patients taking part in clinical trials of new medicines. These measures are based on European legislation aimed at harmonising the standard of clinical trials on new medicines throughout the European Union (Clinical Trials Directive (2001/20/EC) - read more here). Further information about the Clinical Trials Directive is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) - go to the website here. Furthermore, the UK Medical Research Council and the Department of Health have jointly developed a Clinical Trials Toolkit - read more here, which provides guidance on how to meet the new regulations.
Clear guidance is also available from the World Medical Association’s Declaration of Helsinki (2000 - read more here, the MRC’s Guidelines for Good Clinical Practice in Clinical Trials - download as a PDF here[Go to note 1], the General Medical Council’s Research: The Role and Responsibilities of Doctors (2002), and the EU Directive 2001/20/EC on Good Clinical Practice - read more here. There has been concern that new regulations may indirectly impede research by increasing regulatory burden. The Government’s Better Regulation Task Force, which was established to advise on action to ensure that regulation is necessary, fair, affordable and simple to understand and administer, is currently looking into science and innovation.