Harris welcomes report into clinical trials

1.42.02pm UTC (GMT +0000) Thu 25th May 2006

Dr Evan Harris, Liberal Democrat Science Spokesman, today welcomes the Medicines and Healthcare Products Regulatory Agency (MHRA) conclusions as their final report into the TGN1412 clinical trials held by Parexel is published.

"While discrepancies were found, none of these contributed to the problems experienced by the volunteers. The key issue is whether this trial, and future trials of similar immune-activating drugs like it, should ever be carried out in this way or even at all. That will only be addressed by the Government's independent inquiry which has yet to report. In the meantime, it is right that the MHRA have imposed a moratorium on such trials.

"Today's report gives no significant cause for concern for the thousands of people currently participating in clinical trials in this country which are of high quality and very important."

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1) The MHRA press release and final report released today, 25th May 2006, are available from: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023822&ssTargetNodeId=389

2) The Government has appointed Professor Gordon Duff to chair an expert working group to consider what this incident reveals about the underlying science and how clinical trials involving these types of products should be managed and authorised in the future.