This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.

First Published in 2001. Routledge is an imprint of Taylor & Francis, an informa company.

For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.

This cutting-edge Research Handbook presents a comprehensive overview of the European Union’s influence on the regulation of the media sector in the digital age. It explores and compares several areas of European legislation that have an impact on the media sector, defined in a broad sense for its capacity to influence the public opinion at large.

Research Handbook on EU Institutional Law offers a critical look into the European Union: its legal foundations, competences and institutions. It provides an analysis of the EU legal system, its application at the national level and the prevalent role of the Court of Justice. Throughout the course of the Handbook the expert contributors discuss whether the European Union is well equipped for the 21st century and the numerous crises it has to handle. They revisit the call for an EU reform made in the Laeken Conclusions in 2001 to verify if its objectives have been achieved by the Treaty of Lisbon and in daily practice of the EU institutions. The book also delves into the concept of a Europe of different speeds, which - according to some - is inevitable in the EU comprising 28 Member States. Overall, the assessment of the changes introduced by the Lisbon Treaty is positive, even if there are plenty of suggestions for further reforms to re-fit the EU for purpose.

Over the years, the European Union has developed relationships with other international institutions, mainly as a result of its increasingly active role as a global actor and the transfer of competences from the Member States to the EU. This book presents a comprehensive and critical assessment of the EU’s engagement with other international institutions, examining both the EU’s representation and cooperation as well as the influence of these bodies on the development of EU law and policy.

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Science for Policy Handbook provides advice on how to bring science to the attention of policymakers. This resource is dedicated to researchers and research organizations aiming to achieve policy impacts. The book includes lessons learned along the way, advice on new skills, practices for individual researchers, elements necessary for institutional change, and knowledge areas and processes in which to invest. It puts co-creation at the centre of Science for Policy 2.0, a more integrated model of knowledge-policy relationship. Covers the vital area of science for policymaking Includes contributions from leading practitioners from the Joint Research Centre/European Commission Provides key skills based on the science-policy interface needed for effective evidence-informed policymaking Presents processes of knowledge production relevant for a more holistic science-policy relationship, along with the types of knowledge that are useful in policymaking