Using Smart Mobile Devices for Collecting Structured Data in Clinical Trials: Results from a Large-Scale Case Study

摘要

In future, more and more clinical trials will rely on smart mobile devices for collecting structured data from subjects during trial execution. Although there have been many projects demonstrating the benefits of mobile digital questionnaires, the scenarios considered in literature have been rather limited so far. In particular, the number of subjects is rather low in respective studies and a well controllable infrastructure is usually presumed, which not always applies in practice. This paper gives insights into the lessons learned in a clinical psychology trial when using tablets for mobile data collection. In particular, more than 1.700 subjects have participated so far, providing us with valuable feedback on collecting trial data with smart mobile devices in the large scale. Furthermore, issues related to an insufficient infrastructure (e.g., unstable Internet connections) have been addressed as well. Overall, the paper provides valuable insights gained during trial execution. In future, electronic questionnaires executable on smart mobile devices will replace paper-based ones.