New measures to better protect clinical trial patients UK
The measures are part of the 2001 EC Clinical Trials Directive, and will ensure that across the EU the danger to patients from poor clinical practice, research misconduct and fraud is reduced.
Whilst most clinical trials conducted in the UK already meet internationally agreed standards of safety and quality, there are isolated cases of bad practice, such as patients taking part in trials who should have been excluded from doing so on medical grounds.
The new regulations, which come into effect from 1st May, will strengthen the safeguards for patients. Under the Directive, all European clinical trials will have to be designed, conducted and reported in accordance with the principles of good clinical practice. As part of this, researchers will have to report all serious adverse reactions to the Medicines Healthcare and Regulatory Authority (MHRA), who will use this information to monitor, and if necessary stop trials if they present a risk to volunteers.
The UK has strongly argued the case for leaving individual countries to decide the details of how they will monitor the quality and safety of trials. In the absence of any new agreement in Europe on what the general principles of good clinical practice should be, the UK has decided to use existing internationally agreed principles which academics and industry in the UK are familiar with and have used since 1996 when an international agreement was signed.
Lord Warner said:
"The safety of volunteers in clinical trials must be our priority. These new measures will make sure that every trial conducted in the UK meets the highest clinical standards so that risks to patients are reduced and that trials are better conducted and their results more credible. We have ensured, wherever possible, that sound systems currently in used in the UK continue.
We have worked closely with research interests and industry to minimise bureacracy and to address any concerns about possible burdens of the new regulations. A better regulatory system inevitably involves some increase in the demands placed on those conducting trials, but ultimately it is in the best interest of both volunteers who participate in trials and for patients, who use the powerful drugs involved".
Notes to editor
1. The Medicines for Human Use (Clinical Trials) Regulations (SI2004/1031) come into force on 1 May 2004. They implement the Clinical Trials Directive (2001/20/EC) into UK law. This Directive aims to harmonise the regulatory environment for clinical trials on medicines in Europe. Its effect is to adopt into law, internationally recognised principles of good practice. The principles both protect individuals and help ensure trials produce reliable evidence.
2. There is further explanation about the Regulations and the Directive on the Medicines and Healthcare Products Regulatory Agency website on www.mhra.gov.uk. From 1 May, clinical trials under the Regulations will require authorisation by the MHRA, as well as a positive opinion from a recognised ethics committee. Manufacturers and importers of the medicines being trialed wil also require a manufacturing authorisation.
3. There was a formal three month consultation on the draft Regulations starting in February 2003. The consultation document was sent to over 3000 organisations. The Department of Health and the Medical Research Council then set up a joint project to codify good practice in publicly funded clinical trials and to investigate concerns. More details can be found at www.ncchta.org/eudirective. The Government has also represented the interests of those in the UK concerned with both commercial and publicly funded clinical trials during discussion in Brussels of EU guidelines, with the aim of avoiding excessively detailed or inappropriate regulation.
4. The Government's aim is to create an environment in which all research in health and social care, including clinical trials, follows well understood principles and standards. The Department of Health Research Governance Framework for Health and Social Care was published in 2001. It promotes explicit agreement on the allocation of responsibilities, and collaboration in robust management and reporting systems that are proportionate to the risks involved in a particular study.
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Noi mãsuri pentru a proteja mai bine studiu clinic pacienþii Regatul Unit - New measures to better protect clinical trial patients UK - articole medicale engleza - startsanatate