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Expert Group on Phase 1 Clinical Trials - Interim Report

Volume 449: debated on Monday 24 July 2006

On 25 May 2006 I informed the House that the Medicines and Healthcare products Regulatory Agency (MHRA) had published its final report on the investigations into the incident that occurred with the phase 1 clinical trial for a drug in development known as TON 1412, Official Report, column 95WS. I also announced the membership of the expert group established by my right hon. Friend the Secretary of State under the chairmanship of Professor Gordon Duff, to consider what the incident revealed about the underlying science, and how clinical trials involving these types of products should be managed in the future. I promised a further report to the House when the expert group provided its interim report.

That interim report is being published tomorrow, 25 July, together with the minutes of all its meetings, the documents submitted for its consideration and details of the evidence given by a wide range of stakeholders, all of which have contributed to its preliminary findings. A copy of the interim report will be placed in the Library.

It is important to recognise that this is an interim report, that a public consultation will take place on its proposals, and further opportunities for interested parties to give evidence will be available in the autumn.

The Government are very grateful for the great deal of progress already made on this important issue by the expert group in the two months since it first met. The group anticipates completing its work in the autumn and I will provide a further report to the House when this report is available.