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.ObjectivesOur 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.MethodsWe 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.ResultsWe 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.
Highlights
Electronic data capture (EDC) systems are used in all phases of clinical trials to collect, manage, and report clinical and laboratory data [1]
The number of published trials that use an EDC system has been rising [7], and there have been claims of a rapid uptake of this technology in clinical trials [8,9]. This optimistic assessment is inconsistent with reports that the failure rate of EDC adoption is as high as 70% [10], and, notwithstanding methodological weakness in the existing evidence, only 20% of trials are using EDC systems
The contributions of this work are as follows: (1) We have developed a scale to assess whether an EDC system is being used and determine its level of sophistication, (2) We have performed a content validation and unidimensional (Guttman) scaling of the EDC sophistication scale, (3) We provided an updated estimate of EDC adoption in Canadian clinical trials, and (4) We have identified which trial factors have an impact on EDC adoption
Summary
Electronic data capture (EDC) systems are used in all phases of clinical trials to collect, manage, and report clinical and laboratory data [1]. The capabilities of those systems vary from the basic stand-alone database used for data entry in a single-site trial, to the more sophisticated systems supporting multisite international trials with remote data entry over the Web, data validation at the time of entry (eg, checking for out-of-range values or impossible combinations of values), real-time status reporting overall and per site, participant status tracking, and on-demand subject randomization. Research should gather stronger evidence on the costs and benefits of using different EDC systems
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