Clinical trials and healthy volunteers

In March 2006, six men who were taking part in testing a new drug, known as ‘TGN1412’, suffered multiple organ failure. This was a Phase I non-therapeutic trial involving healthy volunteers. The incident provoked criticism of the way in which trial participants are recruited, of the fees they are paid and of the regulatory system itself. This paper describes the TGN1412 disaster and explores some of the legal issues arising there from. Volunteers are crucial to the drug development process; yet, there is scant data describing their motivations and attitudes. The paper also reports the findings of an empirical study that the author undertook prior to the TGN1412 incident. Data from this study help to answer questions such as whether the TGN1412 victims were typical of those who volunteer for Phase I trials, the extent to which healthy volunteers are motivated by the participation fees, their understanding of the information they are given and their perceptions of the risks inherent in such trials.