Incidental Diagnosis in Healthy Clinical Trial Subjects

Christopher J.A. Duncan, Rosalind Rowland, Patrick J. Lillie, Joel Meyer, Susanne H. Sheehy, Geraldine A. O'Hara, Matthew Hamill, Hannah Donaldson, Laura Dinsmore, Ian D. Poulton, Sarah C. Gilbert, Helen Mcshane, Adrian V.S. Hill

Research output: Contribution to journalArticlepeer-review


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

Original languageEnglish (US)
Pages (from-to)348-350
Number of pages3
JournalClinical and translational science
Issue number4
StatePublished - Aug 2012
Externally publishedYes


  • Abnormal findings
  • Abnormalities
  • Early phase clinical investigation
  • Ethics
  • Healthy volunteers
  • Incidental diagnosis
  • Phase I clinical trials
  • Prevalence
  • Screening

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)


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