Abstract

The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if the FIH trial involves significant risks. On the other side, scientists interested in having their research validated, corporations with a financial interest in the field, and potential patients and patient support groups desirous of having ..