NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

The Journal of Law and the Biosciences (JLB)

Article:

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

Published: August 13,,2019
https://academic.oup.com/jlb/article/6/1/51/5549623

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.

Plaintiffs in the case of Lerner v Northwest Biotherapeutics also sought to draw links between alleged deficiencies in oversight processes and non-fulfillment of sponsor disclosure obligations.98 At issue in this case were sponsor press releases citing ‘encouraging results’ from an ongoing phase 3 trial of a cancer immunotherapy, DCVax-L. On Aug. 21, 2015, the FDA issued a clinical hold on trial recruitment, leading to a 22 per cent drop in share prices.

One of the statements with which plaintiffs took issue was a sponsor company press release issued on Mar. 7, 2014 stating that the DSMB had made an ‘unblinded review of the safety data … and recommended that the trial continue as planned. The DSMB’s review of the efficacy data is still pending’. Plaintiffs alleged that the interim review had actually commenced in 2013 and would only have taken a few weeks to complete and, accordingly, the review ‘was either completed and buried, or the DSMB had been directed not to complete it’.99 The United States District Court for the District of Maryland dismissed the action. Based on the available facts, Justice Hazel did not accept that an efficacy review had, in fact, been conducted. He further emphasized the separation between DSMB processes and the sponsor company, stating that ‘it is unclear from the Complaint how Plaintiffs attribute the alleged shortcomings of the safety board review to Defendants given their stated lack of involvement’.100