Bioethics Blogs

When is it legitimate to stop a clinical trial early?

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.