Rules to change on drugs trials

Following the much publicised trial of TGN1412 in which six volunteers were left with multiple organ failure, the Medicines and Healthcare products Regulatory Agency (MHRA) have set out changes to drugs trials. A group of independent experts will also launch an inquiry to ensure lessons are learnt from the case.

Initial investigations by the MHRA revealed the test was administered correctly with the correct doses given and no evidence of the drug being contaminated. A spokesman for the MHRA said, “This product showed a pharmacological effect in man which was not seen in pre-clinical tests in animals at much higher doses.”

However a solicitor representing four of the men involved in the study has said none of the four would have taken part in the trial if they had known they would be trialling such a revolutionary drug. He said: “When they were taken through the issues to do with the drug it was never spelt out to them quite how cutting edge it was.”

Under the new rules, first-in-man tests with any novel drug which targets the immune system would need “additional expert opinion on whether the effects seen in the TGN1412 case may be repeated” before being authorised.