04610nam 22007215 450 991050638000332120230810173914.03-030-86778-110.1007/978-3-030-86778-2(CKB)4950000000280191(MiAaPQ)EBC6787288(Au-PeEL)EBL6787288(OCoLC)1281990971(DE-He213)978-3-030-86778-2(PPN)258299045(EXLCZ)99495000000028019120211019d2021 u| 0engurcnu||||||||txtrdacontentcrdamediacrrdacarrierAccess to Non-Summary Clinical Trial Data for Research Purposes Under EU Law /by Daria Kim1st ed. 2021.Cham :Springer International Publishing :Imprint: Springer,2021.1 online resource (310 pages)Munich Studies on Innovation and Competition,2199-7470 ;163-030-86777-3 Includes bibliographical references.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.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.Munich Studies on Innovation and Competition,2199-7470 ;16Information technologyLaw and legislationMass mediaLaw and legislationMedical laws and legislationLawEuropeClinical medicineResearchQuantitative researchIT Law, Media Law, Intellectual PropertyMedical LawEuropean LawClinical ResearchData Analysis and Big DataInformation technologyLaw and legislation.Mass mediaLaw and legislation.Medical laws and legislation.LawEurope.Clinical medicineResearch.Quantitative research.IT Law, Media Law, Intellectual Property.Medical Law.European Law.Clinical Research.Data Analysis and Big Data.342.240662Kim Daria905451MiAaPQMiAaPQMiAaPQBOOK9910506380003321Access to Non-Summary Clinical Trial Data for Research Purposes under EU Law2025186UNINA