State of use of Electronic Data Capture (EDC) tools in randomized controlled trials in India

Abstract

ObjectivesElectronic data capture (EDC) tools can improve data quality gathered in clinical trials and may be more cost-effective. However, limited data is available on the adoption of EDC tools in randomized controlled trials (RCT) conducted in India. The objective of the current study was to determine the EDC adoption rate in RCTs in India. MethodsWe invited investigators of registered RCTs in India to an online survey. The questionnaire included questions on the use of EDC and features available. An EDC sophistication level (range 1 - 6) was computed. Respondents were also asked about barriers to the implementation of EDC. The EDC adoption rate (EAR) was defined as the proportion of clinical trials where EDC with a sophistication level of 2 or more was used. Multivariable logistic regression was used to identify factors that predicted EDC adoption. Results321 responses were received for 400 unique trials (participation rate of 21%), with an EAR of 27.5% (95% confidence intervals : 23.4% to 32.1%, n = 110). The number of sites influenced EDC adoption (odds ratio : 1.26, 95% CI : 1.12 - 1.47, p = 0.001) on multivariable analysis. EAR did not increase over time. The key barriers identified for not using an EDC were lack of technical support (170, 63.0%) and software cost (132, 48.9%). ConclusionsThe survey shows a low EAR in randomized trials registered in India. The barriers identified in the survey would need systematic solutions to improve the EAR in the future.