Skip to main content Site map

Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (ePub eBook) 1st ed. 2021


Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (ePub eBook) 1st ed. 2021

eBook by Kim, Daria

Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (ePub eBook)

£109.50

ISBN:
9783030867782
Publication Date:
19 Oct 2021
Edition:
1st ed. 2021
Publisher:
Springer Nature
Imprint:
Springer
Pages:
300 pages
Format:
eBook
For delivery:
Download available
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (ePub eBook)

Description

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 trialdata 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.aOverall, it is argued thatathe mainstream innovation-based justification for exclusive control over theaoutcomes ofaresearch and development can hardly rationalise trial sponsorsO control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.

Contents

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.

Accessing your eBook through Kortext

Once purchased, you can view your eBook through the Kortext app, available to download for Windows, Android and iOS devices. Once you have downloaded the app, your eBook will be available on your Kortext digital bookshelf and can even be downloaded to view offline anytime, anywhere, helping you learn without limits.

In addition, you'll have access to Kortext's smart study tools including highlighting, notetaking, copy and paste, and easy reference export.

To download the Kortext app, head to your device's app store or visit https://app.kortext.com to sign up and read through your browser.

This is a Kortext title - click here to find out more This is a Kortext title - click here to find out more

NB: eBook is only available for a single-user licence (i.e. not for multiple / networked users).

Back

University of Sussex logo