The Pharmaceutical Journal
Vol 276 No 7403 p649
3 June 2006

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MHRA uncovers inappropriate procedures in Northwick Park trial

Inadequate training, incomplete documentation and inappropriate procedures have been uncovered in the Medicines and Healthcare products Regulatory Agency's report into the adverse events experienced during the clinical trial of TGN1412 at Northwick Park Hospital, London, in March (PJ, 18 March, p307).

Medical history documentation procedures were not adhered to, the agency found, and there was no formal system in place for 24-hour medical cover. In addition, the MHRA found that the physician charged with conducting medical tests when the participants first arrived at the clinical trials clinic did not have the necessary expertise. “MHRA inspectors were not satisfied that the individual had adequate training and experience for the role,” the report concludes.

Parexel, which conducted the trial for TeGenero, TGN1412’s manufacturer, did not review TeGenero’s insurance policy to ensure it was appropriate, as it had a duty to do. There was also no contract in place between Parexel and TeGenero at the start of the trial and only a draft contract between Parexel and the private laboratory it was working with.

The MHRA also criticises Parexel for not adhering to the correct unblinding procedure after the participants began to experience serious adverse events. The placebo volunteers were allowed to leave the trial centre before the appropriate checks had been carried out to confirm that they had received the placebo, the MHRA says, although it acknowledges that the reactions seen in the other volunteers did suggest this was the case.

However, the MHRA does not believe that any of these failings played a part in the severe reactions experienced by the participants. “There were no findings which were believed to be likely to have contributed to the serious adverse events experienced by the trial subjects who received the study drug,” the agency says. In addition, this report by the MHRA agrees with the finding of the interim report (PJ, 8 April, p408) that “an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions in the trial participants”.

The remit and membership of the expert review body set up to review clinical trials in the wake of the incidents at Northwick Park Hospital (PJ, 8 April, p408) was also announced last week. The 18-member group will consider what may be necessary in the transition from pre-clinical to phase 1 studies and in the design of such trials, with specific reference to biological molecules with novel mechanisms of action, new agents with highly species-specific action and new drugs directed towards immune system targets.