Is It Legitimate To Stop Clinical Trials Early On Account Of Their "Opportunity Costs"?

Main Category: Clinical Trials / Drug Trials
Article Date: 09 Jun 2009 - 7:00 PDT

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A provocative debate in this week's PLoS Medicine examines whether it would be legitimate to stop a clinical trial of a global health tool early in order to reallocate the resources to testing newer products.

After the failure of three large clinical trials of vaginal microbicide candidates (chemical agents aimed at preventing HIV infection), a 2007 editorial in Nature stated that the microbicide field "requires a mechanism to help it make rational choices about the best candidates to move through trials." In the PLoS Medicine debate, James Lavery (University of Toronto, Canada) and colleagues propose one such mechanism, based on stopping trials early for "opportunity costs." They argue that microbicide trial sites could have been saturated with trials of scientifically less advanced products, while newer, and potentially more promising, products were being developed. They propose a mechanism to reallocate resources invested in existing trials of older products that might be better invested in more scientifically advanced products that are awaiting clinical testing.

But countering Lavery and colleagues' proposal, David Buchanan (University of Massachusetts, Amherst, USA) argues that stopping trials early for such opportunity costs would pose insurmountable practical barriers, and would risk causing harm to the participants in the trial that was stopped. Funding: James Lavery and colleagues' article was funded by a grant from the Bill & Melinda Gates Foundation (BMGF) to Drs. Singer and Lavery. Lavery and colleagues presented an earlier version of their ideas at the BMGF, and feedback was taken into consideration in revisions of their paper. Peter Singer is also Sun Life Financial Chair in Bioethics at University of Toronto. The funders had no role in the decision to submit the manuscript or in its preparation. David Buchanan received no specific funding for his article.

Citation:
"In Global Health Research, Is It Legitimate To Stop Clinical Trials Early on Account of Their Opportunity Costs?"
Lavery JV, Ridzon R, Singh JA, Slutsky AS, Anisko JJ, et al. (2009)
PLoS Med 6(6): e1000071. doi:10.1371/journal.pmed.1000071

Source
Plos Medicine