Access to Non-Summary Clinical Trial Data for Research Purposes under EU Law

In: Munich Studies on Innovation and Competition Ser. v.16

Abstract

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.