Open AccessIncidental Diagnosis in Healthy Clinical Trial Subjects
Author(s) -
Duncan Christopher J.A.,
Rowland Rosalind,
Lillie Patrick J.,
Meyer Joel,
Sheehy Susanne H.,
O’Hara Geraldine A.,
Hamill Matthew,
Donaldson Hannah,
Dinsmore Laura,
Poulton Ian D.,
Gilbert Sarah C.,
McShane Helen,
Hill Adrian V.S.
Publication year - 2012
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/j.1752-8062.2011.00393.x
Subject(s) - medicine , clinical trial , informed consent , institutional review board , pediatrics , physical therapy , alternative medicine , surgery , pathology
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. Clin Trans Sci 2012; Volume 5: 348–350