It’s impossible to say exactly how many pay-to-participate clinical trials are taking place these days because the researchers who run them don’t often want to include that information when they announce their results. On the other hand, it’s impossible to ignore them, too, because of the ethical questions they pose.
Stat cites trials that transfuse blood or blood platelets taken from young people into older people. Those who run such trials charge, and often charge a lot. A trial last year in Florida charged participants as much as $285,000 for young-blood transfusions. That trial spurred HHS to find out what’s going on. HHS allows pay-to-participate clinical trials under special circumstances, for instance exploring the medical benefits of illicit drugs such as marijuana and LSD. Researchers might have trouble getting funding through traditional channels for these sorts of trials.
Steven Joffe, MD, a pediatric oncologist and bioethicist at the University of Pennsylvania, worries about any exceptions. He tells Stat that “if you open the door to these trials, you inevitably are going to get … exploitative trials, and bad trials, and trials that don’t lead to any useful information.”
The trials may be subject to bias selection based on the fact that only a relatively few people can afford to participate. Also, they may not have a control group because who’s going to pay that much money when there’s a chance they’ll be given a placebo?
Again, it’s hard to say how many such trials are going on but Michele Russell-Einhorn, chief compliance officer for Advarra, Advarra, a company that provides institutional review board services, says that she’s never seen so many pay-to-participate proposals and she’s been on the job 23 years.
She tells Stat: “The examples that we have, that get this kind of media attention, it’s obvious that people shouldn’t be asked to pay to participate in those trials. But there are some where we think we don’t want to have a hardline stance that says no, never, this could never be appropriate, because sometimes, we think, in rare circumstances, it could be ethically acceptable to ask for this kind of cost-sharing.”