Free shipping on orders over $99
Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law

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

by Daria Kim
Paperback
Publication Date: 21/10/2022

Share This Book:

  $219.00
or 4 easy payments of $54.75 with
afterpay
This item qualifies your order for FREE DELIVERY
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.
ISBN:
9783030867805
9783030867805
Category:
Medical & healthcare law
Format:
Paperback
Publication Date:
21-10-2022
Publisher:
Springer Nature Switzerland AG
Country of origin:
Switzerland
Pages:
300
Dimensions (mm):
235x155mm
Weight:
0.49kg

This title is in stock with our Australian supplier and should arrive at our Sydney warehouse within 2 - 3 weeks of you placing an order.

Once received into our warehouse we will despatch it to you with a Shipping Notification which includes online tracking.

Please check the estimated delivery times below for your region, for after your order is despatched from our warehouse:

ACT Metro: 2 working days
NSW Metro: 2 working days
NSW Rural: 2-3 working days
NSW Remote: 2-5 working days
NT Metro: 3-6 working days
NT Remote: 4-10 working days
QLD Metro: 2-4 working days
QLD Rural: 2-5 working days
QLD Remote: 2-7 working days
SA Metro: 2-5 working days
SA Rural: 3-6 working days
SA Remote: 3-7 working days
TAS Metro: 3-6 working days
TAS Rural: 3-6 working days
VIC Metro: 2-3 working days
VIC Rural: 2-4 working days
VIC Remote: 2-5 working days
WA Metro: 3-6 working days
WA Rural: 4-8 working days
WA Remote: 4-12 working days

Reviews

Be the first to review Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law.