Dr Jacqueline Glover Discusses the Complicated Balance of Ethics in Drug Trials
When conducting drug trials, the values of patients and manufacturers can come into conflict, which is why a well-informed ethical framework is needed to evaluate benefits and burdens, according to Jacqueline Glover, PhD, professor in the Department of Pediatrics and the Center for Bioethics and Humanities at the University of Colorado Denver.
Transcript (slightly modified) What are the challenges of creating an ethical framework assessing quality and costs in healthcare? How can facts and research help?
Good ethics starts with good facts. When you’re weighing the benefits and the burdens of a particular drug against the increased costs, you really need good information about the performance of that drug. There is a problem with the data, according to my colleagues. Overall survival, which is the time from drug assignment to death from any cause, is something that patients can understand: “This drug will help me live longer.”
But people who fund trials have other considerations and things that they have to do, so they want shorter trials, less participants in trials. Their concern is to get a drug to market—of course, that’s important too—so they use surrogate endpoints like tumor response or shrinkage or progression-free survival, the time from drug assignment to progressive disease or death from any cause, and these things are not necessarily associated with overall survival.
Also, patients are very interested in quality of life. That’s important. Only some trials try to assess quality of life, and when there are statistics about survival, it’s in the range of 2 to 3 months. I’ve never seen years. It’s not at all clear that the information comes from a clinical trial where there’s really good inclusion and exclusion criteria, and there’s monitoring of how well performance of a drug in clinical trial really compares to how it functions in the real world, if you will, among the general population.