title: Need for a proactive and structured approach to risk analysis when designing phase I trials.
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, University of Utrecht, Netherlands.
authors.forename: Cornelis A
authors.initials: CA
authors.lastname: Van den Bogert
authors.affiliation: Centre for Human Drug Research, 2333 CL Leiden, Netherlands.
authors.forename: Adam F
authors.initials: AF
authors.lastname: Cohen
mesh_terms: D017321:Clinical Trials, Phase I as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D064368:Healthy Volunteers; D006801:Humans; D018570:Risk Assessment