A first-in-man study is a clinical trial where a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time. Sometimes, this is called a Phase 0 study.
Such studies present particular risks to the human subjects as was signally the case in the TGN1412 trial in 2006. Consequently, there are ethical issues as to whether such trials should be performed on healthy volunteers, who have nothing to gain beyond a fee, or on patients who have a chance of enjoying a health benefit.
- Working Party on Statistical Issues in First-in-Man Studies (2007). "Statistical issues in first-in-man studies". Journal of the Royal Statistical Society. 170A: 517–579.
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