Handheld-based Data Collection in a highly distributed Clinical Study (PMS)

Electronic Data Capturing offers a significantly higher ad-hoc quality of study data at the time of entry, which is specifically important for post-marketing type studies where resources for subsequent data cleaning are limited. Internet-based tools provide a good solution to these scenarios as typically large numbers of centres and/or doctors are involved. But while the deployment of Internet-based (online) studies on existing computer equipment is relatively easy, participants might find it sometimes difficult to integrate the electronic documentation effort into the clinical practice. This might be due to limited availability of Internet access, the location of the computers, security concerns etc. The presented case study shows how the introduction of handheld computers can help to overcome these issues and provide for added flexibility and ease of use. Furthermore, actual data regarding the penetration of mobile devices in the medical community in Germany is discussed to give an outlook of the future potential for mobile studies. 1 The EDC challenge Fast and reliable data capturing, high quality through integrated checks and queries, efficient study tracking and communication – Electronic Data Capturing (EDC) offers numerous advantages for clinical studies over the conventional paper-based case report form (CRF). Several reports have demonstrated the cost advantages that can be created by advances in speed and quality of the data acquisition process (e.g. [CNB02]). When EDC was first introduced into the clinical research process, typically dedicated PC systems have been deployed, often in combination with private dial-up networks to transfer the collected data. To overcome the high set-up and support costs associated with the operation of these dedicated systems, the next logical progress moved EDC to the Internet. This has been made possible by the more widespread availability of adequate Internet-access, but even more importantly the advances in standard browser technology and security protocols (e.g. SSL). With Internet (or online) studies, EDC became a viable option for most types of clinical studies, including late-phase (III and IV) trials that involve a large number of centres or even individual doctors at their office.