By Khaled El Emam1,2, BEng, PhD; Elizabeth Jonker1,
BA; Margaret Sampson1, MLIS; Karmela Krleža-Jerić3, MD, MSc,
DSc; Angelica Neisa1, BSc
1Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada
2Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada
3Canadian Institutes of Health Research, Ottawa, ON, Canada
J Med Internet Res 2009;11(1):e8
ABSTRACT
Background: Electronic data capture (EDC) tools provide automated support for
data collection, reporting, query resolution, randomization, and validation, among
other features, for clinical trials. There is a trend toward greater adoption of EDC
tools in clinical trials, but there is also uncertainty about how many trials are actually
using this technology in practice. A systematic review of EDC adoption surveys
conducted up to 2007 concluded that only 20% of trials are using EDC systems,
but previous surveys had weaknesses.
Objectives: Our primary objective was to estimate the proportion of phase II/III/IV
Canadian clinical trials that used an EDC system in 2006 and 2007. The secondary
objectives were to investigate the factors that can have an impact on adoption and
to develop a scale to assess the extent of sophistication of EDC systems.
Methods: We conducted a Web survey to estimate the proportion of trials that were
using an EDC system. The survey was sent to the Canadian site coordinators for
331 trials. We also developed and validated a scale using Guttman scaling to
assess the extent of sophistication of EDC systems. Trials using EDC were
compared by the level of sophistication of their systems.
Results: We had a 78.2% response rate (259/331) for the survey. It is estimated
that 41% (95% CI 37.5%-44%) of clinical trials were using an EDC system. Trials
funded by academic institutions, government, and foundations were less likely to
use an EDC system compared to those sponsored by industry. Also, larger trials
tended to be more likely to adopt EDC. The EDC sophistication scale had six
levels and a coefficient of reproducibility of 0.901 (P< .001) and a coefficient of
scalability of 0.79. There was no difference in sophistication based on the
funding source, but pediatric trials were likely to use a more sophisticated EDC
system.
Conclusion: The adoption of EDC systems in clinical trials in Canada is higher
than the literature indicated: a large proportion of clinical trials in Canada use
some form of automated data capture system. To inform future adoption,
research should gather stronger evidence on the costs and benefits of using
different EDC systems.
Vea el texto completo desde aquí