Research file on TGN1412 missing essential data before start of trial

Authors of a Viewpoint in this week's issue of The Lancet highlight the problems with the phase I first-in-man trial of TGN1412, in which six healthy volunteers developed serious adverse events.

In their Viewpoint, Adam Cohen (Centre for Human Drug Research, Leiden, Netherlands) and Marcel Kenter (Central Committee on Research Involving Human Subjects, The Hague, Netherlands) propose a set of factors to facilitate risk analysis of all new substances to be administered to human beings. When they applied these factors to the data available in the public domain before the TGN1412 trial started, they found that essential information was absent from the research file on the compound. Their analysis concludes that the compound was unsuitable for administration to healthy people without additional pre-clinical experiments.

The authors' comment: "A prerequisite for thorough assessment of the protocol and preclinical data for any clinical trial is that all parties involved have access to all necessary findings. The sponsor has main responsibility for making these results available and should include and discuss the data in the research file. Relevant new information that becomes available after submission should be added and discussed as soon as possible. This process is of special importance in the early and rapid development of a new medicine. From the information that was disclosed, we conclude that the assessors did not receive all relevant findings."

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EMBARGO: 00:01H (London time) Friday October 13, 2006. In North America the embargo lifts at 18:30H Thursday October 12, 2006.

Contact: Dr Marcel Kenter, Central Committee on Research Involving Human Subjects (CCMO), PO Box 16302, 2500 BH The Hague, The Netherlands, tel. +31-70-3406700 m.kenter@ccmo.nl


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