Sd. Singh et Aj. Williams, The prevalence and incidence of medical conditions in healthy pharmaceutical company employees who volunteer to participate in medical research, BR J CL PH, 48(1), 1999, pp. 25-31
Aims Although clinical research in healthy volunteers is commonly performed
there have been few studies of the value of the medical screening of subje
cts. The aim of this study was to investigate the prevalence and incidence
of medical conditions found during the medical screening of 'healthy' subje
cts employed in a pharmaceutical company who volunteered to participate in
medical research.
Methods This was a retrospective study of the medical notes of all the subj
ects who volunteered for membership of the Zeneca Clinical Pharmacology Uni
t's healthy volunteer panel over a 4 year period from 1990 to 1994. The pre
valence of medical conditions found at presentation was determined. The inc
idence of medical conditions during the 4 year observation period was also
ascertained. Medical screening included a full medical history and examinat
ion, clinical chemistry, haematology and urinalysis screens, pulmonary func
tion tests, ECGs, 24 h ambulatory cardiac monitoring and a request for info
rmation from the volunteer's General Practitioner.
Results Prevalence-1293 subjects volunteered to join the panel of which 156
subjects (12%) were not accepted at presentation including 141 (10.9%) for
medical reasons. The most medical common reasons were; previously diagnose
d medical conditions (3.3%), cardiovascular abnormalities (1.9%), abnormal
liver function tests (1.9%) anaemia (1.2%), hyperlipidaemia (1.1%) excess a
lcohol intake (0.6%) and thyroid disease (0.5%). Incidence-36 of the 1137 v
olunteers (0.8% per year) accepted onto the panel subsequently developed me
dical conditions of which the most common were; anaemia (0.29% per year), c
ardiovascular abnormalities (0.13% per year) and vasovagal syncope (0.13% p
er year).
Conclusions This study demonstrates the importance of medical screening bef
ore healthy volunteers participate in clinical research.