Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices
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Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices Markus Hartmann and Florence Hartmann-Vareilles Drug Information Journal 2012 46: 545 originally published online 8 August 2012 DOI: 10.1177/0092861512453574 The online version of this article can be found at: http://dij.sagepub.com/content/46/5/545
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Clinical Trials
Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices
Drug Information Journal 46(5) 545-554 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512453574 http://dij.sagepub.com
Markus Hartmann, PhD, MDRA1, and Florence Hartmann-Vareilles, Avocat2
Abstract 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 time ever ‘‘risk adapted rules’’ in Europe’s legislative framework for clinical trials. Collecting feedback for ‘‘insufficient risk differentiation’’ and ‘‘more precise and risk adapted rules for the content of the application dossier and for safety reporting’’ during 2 consultations disclosed in October 2009 and February 2011,2-4 the European Commission is currently moving forward to apply a ‘‘risk-based approach’’ to clinical research. Although the scope an
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