BACKGROUND: Patient participation in medical decision making is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The European Medicines Agency (EMA) has understood that patient preferences, notions and experiences have the potential to improve the quality and delivery of medical care, reduce overall costs and improve outcomes by accelerating the understanding of how best to incorporate new therapies and technologies into everyday clinical practice. Essentially, these data help fill the knowledge gap between clinical trials and actual clinical practice. Therefore, the demand for data, directly reported by a patient that is based on his or her perception of a disease and its treatment, has strongly increased over the last few years. Today, the legal framework required to set-up these studies varies across European countries.
METHODOLOGY: Documentary Method – critical analysis of country specific legislation, government body requirements and recommendations.
RESULTS: Non-interventional studies collecting patient reported outcomes, preferences and perceptions of a disease and its treatment, require a formal review from an Ethic Committee (EC) in France, Germany and UK. In France, these studies involve human subjects and therefore require a formal review and approval from patient and data protection agencies. In Germany, they can be classified as an ‘Anwendungsbeobachtung’ and an EC review is highly recommended. In the UK, studies without ‘material ethical issues’ are suitable for a Proportionate Review instead of full REC.
CONCLUSIONS: Considering the increasing demand and the extended benefits brought by these patient studies, we wonder why they are excluded from the upcoming regulation for a European harmonized process. We encourage legislators to extend the scope of this new regulation and offer a common and faster ethics review to facilitate the conduct of such studies without mitigating patient protection.
