Open Access Repository

Assessing the legal duty to use or disclose interim data for ongoing clinical trials

Downloads

Downloads per month over past year

Eckstein, L ORCID: 0000-0002-7161-7521 2019 , 'Assessing the legal duty to use or disclose interim data for ongoing clinical trials' , Journal of Law and the Biosciences , pp. 1-34 , doi: 10.1093/jlb/lsz012.

[img]
Preview
PDF (Online first)
134494 - Asses...pdf | Download (414kB)

| Preview

Abstract

Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information.This paper canvasses potential legal obligations to use or disclose emerging clinical trial data, including through tort law and securities laws. The analysis is supplemented by a comprehensive search of US cases in which courts have adjudicated upon such allegations. Notably, available cases demonstrate widespread judicial deference to clinical trial practices designed to shield clinical trial actors from emerging information. As a result, despite a theoretical possibility of legal obligations of use or disclosure, it appears that these will rarely be enforceable.

Item Type: Article
Authors/Creators:Eckstein, L
Keywords: clinical trials, data monitoring
Journal or Publication Title: Journal of Law and the Biosciences
Publisher: Oxford University Press
ISSN: 2053-9711
DOI / ID Number: 10.1093/jlb/lsz012
Copyright Information:

Copyright The Author(s) 2019. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited.

Related URLs:
Item Statistics: View statistics for this item

Actions (login required)

Item Control Page Item Control Page
TOP