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
Kim, Daria
Springer Nature Switzerland AG
10/2021
300
Dura
Inglês
9783030867775
15 a 20 dias
647
Descrição não disponível.
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.
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Clinical trail data;Competition in innovation;Exploratory data analysis;Access to data;Drug research and development
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
