Clinical Trials Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices

Since 2010, discussions about more risk-proportionate trial authorization and supervision procedures gain momentum in the European Union and the United States. This article provides an overview of the current situation and analyses existing proposals for the risk-based assessment and categorization of clinical research. Experiences gained so far with the risk-based categorization and classification of trials and products in the pharmaceuticals and medical devices sector are described: they indicate that strict trial categorization systems would add burden to the whole process and could deliver benefit only within a very flexible regulatory framework. In contrast, partial exemptions from regulatory requirements for well-defined types of trials may respond better to the current expectations of stakeholders. For Europe, such exemptions could be adopted in a custom-made manner with the objective of facilitating the conduct of large, simple, evidence-building clinical trials as well as of patient-focused trials in situations of recognized unmet medical need. Keywords clinical trial legislation, EU Clinical Trials Directive, risk-based approach, quality risk management, clinical investigation of medical devices Through the revision of the EU Clinical Trials Directive,1 the European Commission intends to integrate for the first tim