Urgent changes needed for authorisation of phase I trials
EMBARGO: 00:01H (London time) Friday April 14, 2006. In North America the embargo lifts at 18:30H ET Thursday April 13, 2006.The disastrous events of the TGN1412 trial indicate that urgent change is needed in the approval processes and regulation of phase I trials of biological agents, states an editorial in this week's issue of The Lancet.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) authorised the phase I first-in-man trial of TeGenero's TGN1412 in which six healthy volunteers developed serious adverse events. The MHRA's interim report concludes that there was no evidence of a fault with the quality of the test drug, no contamination, no dosing error, and "it was run according to the agreed protocol". However, as The Lancet comments: "Despite the recognised risk of massive release of cytokines that is clearly described in the product dossier and investigator's brochure, there is no mention in the published documents of any precautionary dosing interval between volunteers. As the Academy of Medical Sciences suggests: 'it would be usual practice to administer a single dose in a single patient, who would then be observed for an appropriate period of time'."
How clinical trials are regulated is now under review following the release of the MHRA's interim report. Those who authorise phase I trials must take into account the differences in predicting toxicity of activating antibodies compared with conventional small molecule drugs, states the editorial.
The Lancet concludes: "The TGN1412 events indicate that urgent change is needed in the approval processes and regulation of phase I trials of biological agents."
Contact: The Lancet press office T) +44 (0) 207 424 4949/4249 [email protected]
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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