New UK regulations to better protect patients taking part in clinical trials

New regulations which will better protect the rights, safety and well-being of patients taking part in clinical trials of medicines were welcomed today by Health Minister, Lord Warner.

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".