LEADER 04610nam 22007215 450 001 9910506380003321 005 20230810173914.0 010 $a3-030-86778-1 024 7 $a10.1007/978-3-030-86778-2 035 $a(CKB)4950000000280191 035 $a(MiAaPQ)EBC6787288 035 $a(Au-PeEL)EBL6787288 035 $a(OCoLC)1281990971 035 $a(DE-He213)978-3-030-86778-2 035 $a(PPN)258299045 035 $a(EXLCZ)994950000000280191 100 $a20211019d2021 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aAccess to Non-Summary Clinical Trial Data for Research Purposes Under EU Law /$fby Daria Kim 205 $a1st ed. 2021. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2021. 215 $a1 online resource (310 pages) 225 1 $aMunich Studies on Innovation and Competition,$x2199-7470 ;$v16 311 $a3-030-86777-3 320 $aIncludes bibliographical references. 327 $aPART 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. 330 $aThis book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors? control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised. 410 0$aMunich Studies on Innovation and Competition,$x2199-7470 ;$v16 606 $aInformation technology$xLaw and legislation 606 $aMass media$xLaw and legislation 606 $aMedical laws and legislation 606 $aLaw$xEurope 606 $aClinical medicine$xResearch 606 $aQuantitative research 606 $aIT Law, Media Law, Intellectual Property 606 $aMedical Law 606 $aEuropean Law 606 $aClinical Research 606 $aData Analysis and Big Data 615 0$aInformation technology$xLaw and legislation. 615 0$aMass media$xLaw and legislation. 615 0$aMedical laws and legislation. 615 0$aLaw$xEurope. 615 0$aClinical medicine$xResearch. 615 0$aQuantitative research. 615 14$aIT Law, Media Law, Intellectual Property. 615 24$aMedical Law. 615 24$aEuropean Law. 615 24$aClinical Research. 615 24$aData Analysis and Big Data. 676 $a342.240662 700 $aKim$b Daria$0905451 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910506380003321 996 $aAccess to Non-Summary Clinical Trial Data for Research Purposes under EU Law$92025186 997 $aUNINA