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

Citation

Eckstein, L, Assessing the legal duty to use or disclose interim data for ongoing clinical trials, Journal of Law and the Biosciences pp. 51-84. ISSN 2053-9711 (2019) [Refereed Article]


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Copyright Statement

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.

DOI: doi:10.1093/jlb/lsz012

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 Details

Item Type:Refereed Article
Keywords:clinical trials, data monitoring
Research Division:Law and Legal Studies
Research Group:Law
Research Field:Law not elsewhere classified
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classified
UTAS Author:Eckstein, L (Dr Lisa Eckstein)
ID Code:134494
Year Published:2019
Deposited By:Office of the Faculty of Law
Deposited On:2019-08-15
Last Modified:2019-10-31
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