The costs associated with adverse event procedures for an international HIV clinical trial determined by activity-based costing.
OBJECTIVE
To determine costs for adverse event (AE) procedures for a large HIV perinatal trial by analyzing actual resource consumption using activity-based costing (ABC) in an international research setting.


METHODS
The AE system for an ongoing clinical trial in Uganda was evaluated using ABC techniques to determine costs from the perspective of the study. Resources were organized into cost categories (eg, personnel, patient care expenses, laboratory testing, equipment). Cost drivers were quantified, and unit cost per AE was calculated. A subset of time and motion studies was performed prospectively to observe clinic personnel time required for AE identification.


RESULTS
In 18 months, there were 9028 AEs, with 970 (11%) reported as serious adverse events. Unit cost per AE was $101.97. Overall, AE-related costs represented 32% ($920,581 of $2,834,692) of all study expenses. Personnel ($79.30) and patient care ($11.96) contributed the greatest proportion of component costs. Reported AEs were predominantly nonserious (mild or moderate severity) and unrelated to study drug(s) delivery.


CONCLUSIONS
Intensive identification and management of AEs to conduct clinical trials ethically and protect human subjects require expenditure of substantial human and financial resources. Better understanding of these resource requirements should improve planning and funding of international HIV-related clinical trials.
Chou
Victoria B
VB
Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
Omer
Saad B
SB
Hussain
Hamidah
H
Mugasha
Christine
C
Musisi
Maria
M
Mmiro
Francis
F
Musoke
Philippa
P
Jackson
J Brooks
JB
Guay
Laura A
LA
D000328:Adult; D002648:Child; D017281:Cost of Illness; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000191:economics; D008297:Male; D011247:Pregnancy; D014454:Uganda