Incidental Diagnosis in Healthy Clinical Trial Subjects

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 f...

Full description

Saved in:
Bibliographic Details
Published in:Clinical and translational science 2012-08, Vol.5 (4), p.348-350
Main Authors: 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.
Format: Article
Language:English
Subjects:
abnormal findings
abnormalities
Adolescent
Adult
Age groups
Aged
Brief Report
Clinical trials
Clinical Trials as Topic
Diagnosis
early phase clinical investigation
Ethics
Female
Females
Health
healthy volunteers
Hepatitis
Humans
Hypercholesterolemia
incidental diagnosis
Incidental Findings
Laboratories
Male
Males
Middle Aged
Morbidity
Nephrotic syndrome
Participation
Personal health
phase I clinical trials
prevalence
screening
Statistical analysis
Studies
Volunteers
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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 χ2 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
ISSN:1752-8054
1752-8062
DOI:10.1111/j.1752-8062.2011.00393.x