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MHRA finds faults in TGN1412 trial

But agency reiterates view that adverse reactions were caused by 'unexpected biological action'

Despite identifying some minor procedural discrepancies in the ill-fated clinical trial of the experimental monoclonal antibody, TGN1412, the Medicines and Healthcare products Regulatory Agency (MHRA) has reiterated its stance that it was carried out in accordance with regulations.

In its final report, MHRA identified an ìunexpected biological action of the drug in humansî as the most likely cause of the severe side effects that hospitalised six male volunteers in the Northwick Park trial run by contract research organisation, Parexel.

It concluded that there were no errors in the manufacture, formulation, dilution or administration of TGN1412 and none of the procedural discrepancies it found were linked to the adverse reactions.

The report was warmly received by BioIndustry Association chief executive Aisling Burnand.

ìClinical trials are tightly regulated in the UK and phase I trials have a good safety record,î she said. ìIt is important to recognise the events in the TeGenero trial were exceptional.î

However, personal injury lawyers representing four of the six men branded the report a `whitewash' and called for the government to set up an independent enquiry.

ìIf ever there was a whitewash report this is it,î said Martyn Day, solicitor at Leigh Day & Co. ìThe MHRA could hardly have said less if it had tried. All of the six trialists face the most uncertain of futures. The least the MHRA could have done is ensure our clients understand quite what went on in those terrible few days. It has done no-one any favours by putting out such a bland report.î

Kent Woods, head of the MHRA, said the agency had identified a number of deviations from `good clinical practice', which had no relevance to the outcome.

ìWe will take these up very firmly with the company concerned; we are very insistent on getting compliance,î he commented.

The final report said Parexel had hired a bank screening physician who did not have adequate training and experience, it had failed to complete the full medical background of one volunteer in writing and had also overlooked a review of TeGenero's insurance policy to ensure no exclusion categories were in place.

ìIt is inevitable that following a highly detailed examination of systems and documentation, there would be areas cited for improvement,î said Herman Scholtz, head of international clinical pharmacology at Parexel. ìWe are committed to continuous improvement, and are reviewing, as we always do, ways to enhance our processes and systems.'

An expert group chaired by Gordon Duff, professor of molecular medicine at Sheffield University, has already started analysing clinical trials for monoclonal antibodies to see if any changes to their design are needed.

30th September 2008

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