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

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

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

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

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