Abstract
The introduction of ICT (Information Communications Technology) into the clinical trial system is expected to reduce the time and costs associated with new drug development. Steps are being taken to introduce a new form of communication and information sharing using ICT. However, there are several issues that need to be resolved before it can work efficiently, such as quality assurance of clinical data, security of patients’ personal data, and an effective balance between face-to-face communication and the use of ICT in order to maintain client peace of mind. The objective of this paper is to identify issues relevant to the exchange of clinical information between or among medical doctors, patients, and clinical research coordinators based on existing examples of where ICT has been introduced into clinical trials. Several issues will then be considered in relation to how a clinical information-sharing ICT platform should be managed, taking the framework of P2M platform management into account.
