| Description |
1 online resource (310 pages) |
| Series |
Munich studies on innovation and competition ; v. 16 |
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Munich studies on innovation and competition ; v. 16.
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| Contents |
Intro -- Preface -- Acknowledgements -- Contents -- Abbreviations -- Chapter 1: Introduction -- References -- Part I: Setting the Scene -- Chapter 2: The Context and the Problem -- 2.1 Clinical Trials: General Aspects -- 2.1.1 Basic Definitions -- 2.1.2 The Social Value of Clinical Trials -- 2.1.3 Clinical Trials in the Regulatory Context -- 2.1.3.1 Clinical Trial Approval -- 2.1.3.2 Drug Marketing Authorisation -- 2.1.4 Clinical Trials as a Part of Industry RandD -- 2.2 The Debate Over Access to Clinical Trial Data -- 2.2.1 Concerns Related to Restricted Access to Clinical Trial Data |
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2.2.2 Transparency Issues -- 2.2.3 Levels of Transparency in Clinical Trials -- 2.2.3.1 Trial Registration -- 2.2.3.2 Reporting and Publication of Trial Results -- 2.2.3.3 Accessibility of Non-Summary Data -- 2.2.4 International Norm-Setting Initiatives Promoting Transparency in Clinical Research -- 2.2.5 Institutional Developments -- 2.2.5.1 Editorial Campaign -- 2.2.5.2 Funding Institutions -- 2.2.6 Access to Data as a Digital Resource in the Context of Data-Driven Innovation -- 2.2.6.1 The Promises of ̀Big Data ́ -- 2.2.6.2 Legal and Policy Debate Concerning Ownership of Sensor-Generated Data |
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2.2.6.3 "Big Data" Analysis in Public Healthcare and Drug RandD -- 2.2.6.4 Data-Sharing Policies and Practices Adopted by the Pharmaceutical Industry -- 2.3 Diversity of Policy Approaches and Academic Views -- 2.3.1 The Controversy Over Disclosure of Non-Summary Clinical Trial Data in the EU -- 2.3.1.1 Investigations of the European Ombudsman -- 2.3.1.2 The EMA Transparency Policies -- 2.3.1.3 Evolving Case Law of the CJEU on Clinical Trial Data Disclosure -- 2.3.2 Policy Approaches in Other Jurisdictions -- 2.3.3 Academic Discourse -- 2.3.3.1 General Medical Literature |
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2.3.3.2 Legal Discourse on Access to Clinical Trial Data -- Removing Financial Ties with the Industry -- Disclosure as a quid pro quo for Data Exclusivity Protection -- Amending the Freedom of Information Legislation -- 2.3.3.3 Comparative and International Law Perspectives -- 2.4 The Present Study Against the Background of Policy and Legal Discourse -- References -- Chapter 3: Secondary Analysis of Individual Patient-Level Clinical Trial Data: A Primer -- 3.1 Clinical Trial Data -- 3.1.1 Definitions and General Aspects -- 3.1.2 The Types of Clinical Trial Data |
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3.1.3 The ̀Life-Cycle ́of Clinical Trial Data -- 3.2 Clinical Trial Data as a Source of Medical Knowledge -- 3.2.1 Clinical Trial Data as a Source of Scientific Knowledge -- 3.2.2 The Types of Data Analyses -- 3.2.2.1 Primary and Secondary Data Analyses -- 3.2.2.2 Confirmatory Secondary Data Analysis -- 3.2.2.3 Exploratory Secondary Analysis -- 3.2.2.4 Subgroup Data Analysis -- 3.2.2.5 Interaction Analysis -- 3.2.2.6 Predictive Models and Prognostic Variables -- 3.2.2.7 Meta-analysis and Systematic Reviews -- 3.2.3 Fields of Research -- 3.2.3.1 Pharmacology |
| Summary |
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 |
| Notes |
3.2.3.2 Epidemiology, Clinical Epidemiology and Pharmacoepidemiology |
| Bibliography |
Includes bibliographical references |
| Notes |
Online resource; title from PDF title page (SpringerLink, viewed November 3, 2021) |
| Subject |
Clinical trials -- Law and legislation -- European Union countries
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Freedom of information -- European Union countries
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Clinical trials -- Law and legislation
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Freedom of information
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European Union countries
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| Form |
Electronic book
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| ISBN |
9783030867782 |
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3030867781 |
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