Supporting information ethical considerations

The initial strategy for Phase I is to conduct a single-dose safety study in normal volunteers. The first trial demands close 24-hour supervision in a clinical setting. Ethical considerations may, however, demand that only patients be used, for example, when evaluating an anticancer agent with predictable toxicity. A repeat dose tolerance and pharmacokinetic study in normal or patient volunteers is then conducted for chronically administered drugs. These studies will provide the necessary safety information to support efficacy testing. 

In this chapter I have outlined broad ethical and societal considerations which impact on pharmacovigilance. In terms of ethics, a balance is required between protecting individuals and the common good. To support system credibility, the need for transparency of drug safety information and processes is increasingly being recognised. It would be in everyone s interest if society... 

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