Trial Participants Don’t Care About Conflicts
7 CommentsBy Ed Silverman // December 18th, 2007 // 3:58 pm
That’s what a new study claims. The willingness to participate in a clinical investigation of a new drug or device is not affected by the investigator’s financial stake in the outcome of the trial, according to an article in the Food and Drug Law Journal (subscription required).
Researchers asked 297 college students at George Mason Univeristy to agree to participate in a study involving a dietary supplement that might improve memory. Students were either told that the investigator was an employee of the company, that he was an employee and consultant, or that he was an employee and a patent holder.
The study found that the willingness to participate was not affected by these three different conflict of interest disclosures. However, the study did find that students who rated the investigator as more trustworthy were more likely to agree to participate, but that the evaluation of trustworthiness was not influenced by the extent of the investigator’s financial stake. On the other hand, cash on the barrelhead matters. Students who were told they would receive $20 were significantly more likely to want to participate than students offered no money.
“If replicated, these findings could affect the way in which clinical study disclosure requirements are established and implemented,†says Greg Guagnano, a sociology and anthropology professor at GMU, and co-author.
“There are a number of reasons to mandate disclosures, but this study suggests that disclosure of conflicts may not play a large role in decision-making,” says the other author, Jeff Gibbs, a lawyer with Hyman, Phelps & McNamara. “Given that some courts have reached decisions based on their believing that knowledge of a financial stake would actually change people’s behavior, this study shows that courts need to rely on facts, not assumptions.â€
Curiously, the press release we received by e-mail failed to disclose that Gibbs’ law firm represents many drugmakers.
Dan
As mentioned briefly and vaguely in this post, the study subjects, who are young, I presume, and students, understandably are apathetic about the consequences of any conflicts of interest. They possibly may not be able to, or rather choose not to with deliberate intent, take the effort and cognition to conceptulize the consequences of such conflicts due to the variables associated with them during such studies, and thier motivations. People have been known to do much worse for money and avoid analysis of what is asked of them due to the cash or other incentives associated with thier participation in such activities. In fact, it is my belief they will be rather successful in corporate life in the future, if thier stance continues as they progress in life.
James
Although not particularly relevant to the topic vis-a-vis pharma, let me just say:
Go Patriots!
James Culp
Proud Alumnus, George Mason University
Lisa Van S
College students can easily be swayed when money is offered, especially if that student is poor.
Matt
Stupid humans…
ol cranky
Dan and Lisa have hit the nail on the head. It’s the cash that counts most for healthy volunteers, especially college students living on ramen and cost cutter mac-n-cheese.
You may find similar results in patients with severe disease as well. A willingness to participate despite conflicts of interest in this population would just be indicative of their desire to find any treatment that would help them get better and, possibly, a belief that the physician’s personal stake in the treatment/manufacturer meant the physician has a lot faith in the treatment’s efficacy and safety.
I think there’s still a problem with mistrust of pharma and physicians among patients with mild to moderate disease states (especially minorities) otherwise recruitment for study subjects wouldn’t be any near as much an uphill battle. This is a population that has to really trust the PI and/or study coordinator to be willing to participate (providing the study stipend is not so high as to be coercive). This is also a population that has to weigh the risk of exacerbation of underlying disease during study participation.
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[...] Over at Pharmalot, word of a study of nearly 300 clinical trial participants at George Mason University found that prospective participants were not swayed much by three different stated financial conflicts of interest disclosed by the trial researchers. The would-be guinea pigs were swayed a little more by the presence of a check. [...]
BLOGSCAN - What Do Research Subjects Really Think About Investigators’ Conflicts of Interest | The Healthy Living
[...] Conflicts of Interest Email This Post On the PharmaLot blog, Ed Silverman posted about a new study that purported to show that research subjects don’t care about conflicts of [...]