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

Inbunden, Engelska, 2021

Av Daria Kim

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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.

Produktinformation

Utgivningsdatum2021-10-20
Mått155 x 235 x 23 mm
Vikt647 g
FormatInbunden
SpråkEngelska
SerieMunich Studies on Innovation and Competition
Antal sidor300
Upplaga21001
FörlagSpringer Nature Switzerland AG
ISBN9783030867775

Tillhör följande kategorier

Hälso- och sjukvårdsrätt inom Juridik
Medicinsk utrustning och medicinska tekniker inom Medicin
Internationell rätt inom Juridik
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Databaser inom Data och it

Daria Kim is senior research fellow at the Max Planck Institute for Competition and Innovation (Munich), where she works on the topics related to the regulation of the data economy and life sciences. Prior to joining Max Planck Institute, she worked as a research associate at the Chinese University of Hong Kong. She holds MA (Indiana University of Pennsylvania), LLM (Munich Intellectual Property Law Center) and Dr. iur. (the University of Augsburg) degrees.

PART ONE: Setting the Scene.- Introduction.- The Context and the Problem in Focus.- Secondary Analysis of Clinical Trial Data - A Primer.- PART TWO: Analysis de lege lata,- Legal Sources of Control over and Access to Clinical Trial Data under the EU Applicable Framework.- Implications of IPD Disclosure for Statutory Innovation Incentives PART THREE: Analysis de lege ferenda.- Defining the Intervention Logic of Access-To-Data Measures - A Problem Analysis.- Access to Clinical Trial Data as a Case on R&D Externalities - A Theoretical Framework.- IPD as a Research Resource - Exclusively Controlled or Readily Accessible?.- Evaluating Legislative Options.- Final Conclusions and the Outlook.