Experts set to examine clinical trial process after adverse events at Northwick Park
Clinical trial, immunology and toxicology experts are to examine how the trial process should be modified after the incident
at Northwick Park Hospital (PJ, 25 March, p342).
The expert group, headed by Gordon Duff, chairman of the Committee on
Human Medicines, will look at the transition from pre-clinical to phase
I trials and the design of these trials, the Medicines and Healthcare
products Regulatory Agency announced this week. It will then advise the
Government on the future authorisation of such trials, producing an interim
report within three months. Until the group completes its report, no
phase I trial of a novel molecule targeting the immune system and acting
via a novel mechanism will be authorised unless the MHRA has an additional
expert opinion that the substance will not cause effects similar to those
seen in the Northwick Park case.
The establishment of the group was announced as the MHRA revealed the
results of its preliminary investigation into what went wrong in the
Northwick Park trial. The MHRA said it had found no evidence to suggest
there was any problem with the manufacture of the product or the conduct
of the trial. “If these findings are confirmed, it would indicate
that this product showed a pharmacological effect in man which was not
seen in pre-clinical tests in animals at much higher doses,” Kent
Woods, chief executive of the MHRA said. |
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