When is it legitimate to stop a clinical trial early?

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Stopping early?

Stopping early?

Inspired by a paper that I’m working on with a few of my colleagues from the STREAM research group on the subject of the accrual of subjects in human research, I’ve been reading through a number of articles related to the question, When is it legitimate to stop a clinical trial that is already in progress?

Lavery et al. identify a problem in allocating research resources in human research in their debate, In Global Health Research, Is It Legitimate To Stop Clinical Trials Early on Account of Their Opportunity Costs? (2009) The development of next-generation drug products often outstrips the capacity for testing them, resulting in a queue, and possibly less-than-optimal use of our resources in developing new drugs. They suggest that there should be a mechanism for ending a clinical trial early on the basis of “opportunity costs.” That is, while trials are already terminated early on the basis of futility, efficacy or safety concerns, an ongoing trial might not be the best use of scare healthcare resources, and there should be a way to divert resources to something more promising. Two options are proposed: a scientific oversight committee, or an expanded mandate for the DSMB. The procedure for making such decisions is based on Daniels’ “accountability for reasonableness.”

Buchanan responds, saying it is unethical and impractical to do so. He argues it is unethical because such a practice could not be justified in terms of the harm or benefit to the patients, and that it is difficult to see who would be harmed if ongoing trials were not stopped for opportunity costs. He argues that it is impractical because an accountability for reasonableness-based procedure would mire drug development in corporate lobbying, appeals, and deliberations on a virtually unlimited range of value considerations.

Lavery et al. rebut that the “interest [of advancing science] might be better served by adopting our proposal, rather than locking participants into a trial of a potentially inferior product,” and contrary to Buchanan’s claims, DSMB decisions are rarely certain. Buchanan concludes the paper by rejecting the position of Lavery et al. on no uncertain terms.

While this article does point out a big problem, the solutions proposed by Lavery et al. may present practical problems for a number of reasons, as Buchanan argues. The ethics of early termination is given short shrift in this work, and a more nuanced discussion is needed.

BibTeX

@Manual{stream2013-205,
    title = {When is it legitimate to stop a clinical trial early?},
    journal = {STREAM research},
    author = {Benjamin Gregory Carlisle},
    address = {Montreal, Canada},
    date = 2013,
    month = may,
    day = 24,
    url = {http://www.translationalethics.com/2013/05/24/when-is-it-legitimate-to-stop-a-clinical-trial-early/}
}

MLA

Benjamin Gregory Carlisle. "When is it legitimate to stop a clinical trial early?" Web blog post. STREAM research. 24 May 2013. Web. 17 Oct 2019. <http://www.translationalethics.com/2013/05/24/when-is-it-legitimate-to-stop-a-clinical-trial-early/>

APA

Benjamin Gregory Carlisle. (2013, May 24). When is it legitimate to stop a clinical trial early? [Web log post]. Retrieved from http://www.translationalethics.com/2013/05/24/when-is-it-legitimate-to-stop-a-clinical-trial-early/


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