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Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices
First, provide an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data.
Second, review the wider policy implications and interface of these central EU-level policies with current data disclosure policies at the EU member state level, looking at five EU countries: Germany, Italy, Spain, Sweden, and the U.K.
Clinical trials represent one of the most important activities carried out by biopharmaceutical companies, scientists, and researchers today. They are fundamental components of the biopharmaceutical research and development process of new medicines and medical technologies. For individual countries and national economies, clinical trials provide direct social and economic benefits. Most obviously, clinical research enables the development of cutting-edge treatments, making novel and innovative medical technologies and products available to patients.
The EU has for a number of years seen a gradual decrease in clinical trial activity. Indeed, across the EU great disparity exists between top and bottom performers. Significantly, both EMA’s transparency policy and Regulation 536/2014 seek to stimulate and reverse this trend. It is within this wider context of the state of clinical research in the EU that this report seeks to examine the implications of the new EU regulation on clinical trials and EMA’s policy on data disclosure.
Based on this analysis the report highlights three key dimensions of the transparency and data disclosure debate:
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