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. 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.

Bibliography

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.

Clinical research and experimental design

Overview	Clinical trial Trial protocols Adaptive clinical trial Academic clinical trials Clinical study design

Controlled study (EBM I to II-1; A to B)	Randomized controlled trial Scientific experiment Blind experiment Open-label trial

Observational study (EBM II-2 to II-3; B to C)	Cross-sectional study vs. Longitudinal study, Ecological study Cohort study Retrospective Prospective Case-control study (Nested case-control study) Case series Case study Case report

Epidemiology/ methods	occurrence: Incidence (Cumulative incidence) Prevalence Point Period association: absolute (Absolute risk reduction, Attributable risk, Attributable risk percent) relative (Relative risk, Odds ratio, Hazard ratio) other: Clinical endpoint Virulence Infectivity Mortality rate Morbidity Case fatality rate Specificity and sensitivity Likelihood-ratios Pre/post-test probability

Trial/test types	In vitro In vivo Animal testing Animal testing on non-human primates First-in-man study Multicenter trial Seeding trial Vaccine trial

Analysis of clinical trials	Risk–benefit ratio Systematic review Replication Meta-analysis

Interpretation of results	Selection bias Survivorship bias Correlation does not imply causation Null result

Category Glossary List of topics

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