Access To Non Summary Clinical Trial Data For Research Purposes Under Eu Law
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Access To Non Summary Clinical Trial Data For Research Purposes Under Eu Law
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Author : Daria Kim
language : en
Publisher:
Release Date : 2021
Access To Non Summary Clinical Trial Data For Research Purposes Under Eu Law written by Daria Kim and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with categories.
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.
Access To Non Summary Clinical Trial Data For Research Purposes Under Eu Law
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Author : Daria Kim
language : en
Publisher: Springer Nature
Release Date : 2021-10-19
Access To Non Summary Clinical Trial Data For Research Purposes Under Eu Law written by Daria Kim and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-19 with Law categories.
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.
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
The Cambridge Handbook Of Investment Driven Intellectual Property
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Author : Enrico Bonadio
language : en
Publisher: Cambridge University Press
Release Date : 2023-03-23
The Cambridge Handbook Of Investment Driven Intellectual Property written by Enrico Bonadio and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-23 with Law categories.
This handbook challenges the conventional wisdom that intellectual property is the law of creativity. Traditionally, IP has been instrumental for protecting creations of the mind, with only inventors of original works enjoying exclusive rights. Related, sui generis, and quasi-IP rights, which protect monetary investments and efforts rather than originality and inventiveness, were considered exceptions to the general principles of IP. But increasingly, IP rights are being granted to safeguard corporate investments. This handbook brings together an international roster of contributors to explore this emerging trend. Why are investments the primary driver of legal protection, and often the main requirement to obtain it? Who benefits from such new forms of protection? What should the scope of these new rights be? And are they desirable in the first place? In doing so, the volume is the first to highlight and systematically critique the move from 'intellectual' to 'investment' property.
The Interface Of Intellectual Property Law With Other Legal Disciplines
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Author : Christophe Geiger
language : en
Publisher: Edward Elgar Publishing
Release Date : 2025-05-14
The Interface Of Intellectual Property Law With Other Legal Disciplines written by Christophe Geiger and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-14 with Law categories.
This incisive book explores the interactions between intellectual property (IP) laws and other legal disciplines, examining potential policy implications raised by the growing influence of various legal frameworks on IP principles. Illustrating these issues, the book analyzes how they have shaped our understanding of IP laws and doctrines. Leading specialists debate the intersection of different areas of private, public and criminal law with intellectual property rights, drawing some forward-looking conclusions on the implications at legislative, judicial and theoretical level.
Regulatory Protection In The Pharmaceutical And Life Science Industries
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Author : Żaneta Zemła-Pacud
language : en
Publisher: Edward Elgar Publishing
Release Date : 2025-06-09
Regulatory Protection In The Pharmaceutical And Life Science Industries written by Żaneta Zemła-Pacud and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-09 with Law categories.
This book examines the EU framework for regulatory protection in life science industries, with a particular focus on the pharmaceutical sector. Żaneta Zemła-Pacud discusses the rules governing regulatory exclusivities and rewards for innovative life science products and the regulatory data underlying them. The author presents the framework's meaning for the sector as a sui generis instrument of protection of Intellectual Property and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation.
Open Scientific Data
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Author : Vera J. Lipton
language : en
Publisher:
Release Date : 2020
Open Scientific Data written by Vera J. Lipton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Big data categories.
Public science is critical to the economy and to society. However, much of the beneficial impact of scientific research only occurs when scientific knowledge is disseminated broadly and is used by others. This book examines the emerging policy, law and practice of facilitating open access to scientific research data. One particular focus is to examine the open data policies recently introduced by research funders and publishers, and the potential in these for driving the practice of open scientific data into the future. This study identifies five major stumbling blocks to sustainable open scientific data. Firstly, it is the prevailing mindset that facilitating open access to data is analogous to facilitating open access to publications and, therefore, research data can easily be shared, with research funders and librarians effectively leading the process. Secondly, it is the unclear meaning of the term data which causes confusion among stakeholders. Thirdly, it is the misunderstood incentives for data sharing and the additional inputs required from researchers. Fourthly, data privacy—an issue that only applies to selected research datasets, and yet appears to dominate the discussion about open research data. Finally, there is a copyright law, which poses challenges at different stages of data release and reuse. In this book, it is argued that the above problems can be addressed using a staged model for open scientific data. I draw specifically on the practice with open scientific data at CERN (the European Organization for Nuclear Research) and the practice of sharing clinical trial data to argue that open data can be shared at various stages of processing and diversification. This model is supplemented by recommendations proposing changes to existing open data mandates and the introduction of a text and data mining exemption into Australian copyright law.
Research Handbook On European Property Law
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Author : Sjef van Erp
language : en
Publisher: Edward Elgar Publishing
Release Date : 2024-10-03
Research Handbook On European Property Law written by Sjef van Erp and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-03 with Law categories.
Bringing together global experts in the field, this Research Handbook presents an overview of recent developments in property law in European jurisdictions and in European Union law. It analyses the ways in which these frameworks adapt to modern challenges such as climate change, digitalisation, an ageing population and the effects of pandemics.
Research Handbook On Eu Data Protection Law
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Author : Kosta, Eleni
language : en
Publisher: Edward Elgar Publishing
Release Date : 2022-04-19
Research Handbook On Eu Data Protection Law written by Kosta, Eleni and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-19 with Law categories.
Bringing together leading European scholars, this thought-provoking Research Handbook provides a state-of-the-art overview of the scope of research and current thinking in the area of European data protection. Offering critical insights on prominent strands of research, it examines key challenges and potential solutions in the field. Chapters explore the fundamental right to personal data protection, government-to-business data sharing, data protection as performance-based regulation, privacy and marketing in data-driven business models, data protection and judicial automation, and the role of consent in an algorithmic society.
Transparency Power And Influence In The Pharmaceutical Industry
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Author : Katherine Fierlbeck
language : en
Publisher: University of Toronto Press
Release Date : 2021-06-14
Transparency Power And Influence In The Pharmaceutical Industry written by Katherine Fierlbeck and has been published by University of Toronto Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-14 with Health & Fitness categories.
There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.