First-in-man study
Encyclopedia
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 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 patient
s who have a chance of enjoying a health benefit.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
where a medical procedure, previously developed and assessed through in vitro
In vitro
In vitro refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments...
or animal testing
Animal testing
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...
, or through mathematical modelling is tested on human
Human
Humans are the only living species in the Homo genus...
subjects for the first time.
Such studies present particular risks to the human subjects as was signally the case in the TGN1412
TGN1412
TGN1412 is the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first human subjects to receive the drug....
trial in 2006. Consequently, there are ethical
Medical ethics
Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...
issues as to whether such trials should be performed on healthy volunteers, who have nothing to gain beyond a fee, or on patient
Patient
A patient is any recipient of healthcare services. The patient is most often ill or injured and in need of treatment by a physician, advanced practice registered nurse, veterinarian, or other health care provider....
s who have a chance of enjoying a health benefit.