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). 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), 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. These measures are based on European legislation (directives).
Further information about regulations that apply to the conduct of Clinical Trials is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website. Furthermore, the UK Medical Research Council and the Department of Health have jointly developed a Clinical Trials Toolkit, 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), the MRC's Guidelines for Good Clinical Practice in Clinical Trials, the General Medical Council's Research: The Role and Responsibilities of Doctors (2002), and the EU Directive 2001/20/EC on Good Clinical Practice.
In addition to authorising clinical trials, ethics committees are increasingly expected to monitor the progress of the trials throughout each phase.
What are clinical trials?
Definition
Process for drugs
Regulation and guidance
Informed consent