First-in-man study

First-in-man study

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.

Such studies present particular risks to the human subjects as was signally the case in the disastrous 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.

Bibliography

*cite journal
journal=Journal of the Royal Statistical Society
volume=170A
pages=517–579
author=Working Party on Statistical Issues in First-in-Man Studies
year=2007
title=Statistical issues in first-in-man studies


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