Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms

摘要

Patient empowerment is acclaimed as one of the major trends in the health care area bringing forward new conceptions how to involve patients in clinical research in a more (inter)active way. Patients and clinicians could benefit from more flexible consent-management and improved communication processes. This is where technology comes as an asset - the novel technological approaches promise to give more control to the patient, lessen the burdens on the researchers and all that in compliance with the legal and ethical requirements (e.g. data protection). The views of the European projects EURECA and p-medicine serve as examples for European approaches to patient empowerment.