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Clinical Trials

Volume 687: debated on Thursday 7 December 2006

My honourable friend the Minister of State, Department of Health (Andy Burnham) has made the following Written Ministerial Statement.

On 24 July, I informed the House that the Department of Health had published an interim report from the expert scientific group on phase 1 clinical trials. The expert scientific group was established at the request of the Secretary of State for Health, under the chairmanship of Professor Gordon Duff, with the following terms of reference:

To consider what may be necessary in the transition from pre-clinical to first-in-man phase 1 studies, and in the design of these trials, with specific reference to:

biological molecules with novel mechanisms of action;

new agents with a highly species-specific action; and

new drugs directed towards immune system targets.

To provide advice in the form of a report to the Secretary of State for Health for the future authorisation of such trials with an interim report to be provided within three months.

The expert scientific group submitted their final report to the Secretary of State on 30 November and it is being published today.

The report contains 22 recommendations, which fall into a number of key areas:

additional precautionary measures to apply to the approval and conduct of trials involving high-risk compounds;

the need for scientific advice from independent experts before trials of high-risk substances are approved;

better communication between regulators and drug developers and between regulators and ethics committees;

the skills needed by those conducting clinical trials and how in the future these might be acquired;

the location of trial units and the provision of adequate medical back up in case of problems arising; and

wider availability of information about unpublished clinical trials and adverse reactions occurring in trials.

The Government welcome the recommendations made by the expert scientific group and will give them full consideration. Those recommendations that introduce precautionary measures in the approval and conduct of trials have already been implemented in the UK on an interim basis by the Medicines and Healthcare products Regulatory Agency (MHRA). These interim arrangements will remain until they are replaced by European guidance. We will make every effort to ensure that implementation of these, and other recommendations that require European-level implementation, are given priority.

The MHRA has also put in place procedures for accessing independent scientific advice, and an expert advisory group that will review applications for trials of high risk substances will be established in the new year. Recognising the need for better communication between the main organisations responsible for approval of clinical trials, the MHRA and the UK Ethics Committee Authority (UKECA) jointly published a memorandum of understanding on 30 October 2006, setting out what information should, in the future, be shared between MHRA and research ethics committees.

We will be discussing with the relevant stakeholders, including the pharmaceutical industry and academia, how we can best ensure that the necessary changes are made to training programmes for staff involved in designing and conducting clinical trials, and how to ensure that trial units are appropriately located and equipped.

Some of the expert scientific group's recommendations, such as those proposing greater sharing of information about trials and adverse reactions, have international implications. We will identify appropriate ways of taking these recommendations forward, and ensure that action to implement them is appropriately prioritised.

It is important not to lose sight of the fact that phase 1 studies have an extremely good safety record. The events associated with the TGN 1412 study are extremely rare and were wholly unexpected. The Government are, however, aware of the continuing impact this tragic incident is having on the lives of the volunteers who were involved in this trial, and on their families. The volunteers have received, and will continue to receive, all appropriate NHS care, and we believe that implementing the wide ranging and comprehensive recommendations made in this report will make a significant contribution to the safety of clinical trials of high risk substances in the future.

Finally, I would like to express the Government's grateful thanks to the expert scientific group on phase 1 clinical trials and in particular to its chairman, Professor Gordon Duff, for the work it has undertaken in producing an impressive, authoritative and thorough review of the issues raised by the TGN 1412 clinical trial and in providing a range of soundly based recommendations for the future safety of such trials.