title: Incidental diagnosis in healthy clinical trial subjects.
abstract: Previously unrecognized medical conditions identified in volunteers for early phase clinical studies have significant clinical and ethical implications for the participant. It is therefore crucial that the potential for unexpected diagnosis is addressed during the informed consent process. But the frequency of incidental diagnosis in healthy volunteers who attend for clinical trial screening remains unclear. To assess this we retrospectively analyzed 1,131 independent screening visits for 990 volunteers at a single academic center over a 10-year period to describe the frequency and nature of new clinical findings. Overall 23 of 990 volunteers (2.3%) were excluded at screening for a newly diagnosed medical abnormality. Some clinically important conditions, such as nephrotic syndrome and familial hypercholesterolemia were identified. The frequency of abnormalities was associated with increasing age in males (p= 0.02 χ(2) for trend) but not females (p= 0.82). These data will assist those planning and conducting phase I/II vaccine trials in healthy volunteers, and importantly should strengthen the informed consent of future trial participants.
authors.affiliation: Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Drive, OX3 7LJ, United Kingdom. chrisduncan@doctors.net.uk
authors.forename: Christopher J A
authors.initials: CJ
authors.lastname: Duncan
authors.forename: Rosalind
authors.initials: R
authors.lastname: Rowland
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Lillie
authors.forename: Joel
authors.initials: J
authors.lastname: Meyer
authors.forename: Susanne H
authors.initials: SH
authors.lastname: Sheehy
authors.forename: Geraldine A
authors.initials: GA
authors.lastname: O'Hara
authors.forename: Matthew
authors.initials: M
authors.lastname: Hamill
authors.forename: Hannah
authors.initials: H
authors.lastname: Donaldson
authors.forename: Laura
authors.initials: L
authors.lastname: Dinsmore
authors.forename: Ian D
authors.initials: ID
authors.lastname: Poulton
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Gilbert
authors.forename: Helen
authors.initials: H
authors.lastname: McShane
authors.forename: Adrian V S
authors.initials: AV
authors.lastname: Hill
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D005260:Female; D006262:Health; D006801:Humans; D033162:Incidental Findings; D008297:Male; D008875:Middle Aged; D055815:Young Adult