WASHINGTON, Dec. 18 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, concludes a new study reported in an article in the latest issue of the Food and Drug Law Journal, published by the Food and Drug Law Institute.
Clinical studies are essential to obtain FDA approval of new drugs and certain devices. These studies are conducted by clinical investigators, who sometimes have a financial stake in the outcome of the clinical trial, or financial ties with the sponsor of the investigation. While there has been considerable discussion regarding when these financial interests must be disclosed to potential study participants -- and more broadly, when financial interests must be publicly disclosed -- the actual impact of this disclosure on potential study subjects has received much less attention.
Now, according to a study conducted by Gregory A. Guagnano, Ph.D., Associate Professor of Sociology and Anthropology at George Mason University (GMU) (Fairfax, Virginia) and Jeffrey N. Gibbs of Hyman, Phelps & McNamara, P.C. (Washington, DC), there's evidence that the investigator's financial stake in the trial may not be that important an issue for potential participants.
Guagnano and Gibbs asked 297 undergraduate students at GMU how likely they would be 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. 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, offering the students money did significantly affect their willingness to participate. Students who were told they would receive $20 were significantly more likely to want to participate than students offered no money.
Commented Guagnano, "The study suggests that learning about an investigator's financial stake may have a relatively limited impact on deciding whether to participate. If replicated, these findings could affect the way in which clinical study disclosure requirements are established and implemented."
Gibbs added, "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. 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."
The article appears in Vol. 62, Issue 4 of the Food and Drug Law Journal.
For more information or to obtain a copy of the article, contact Michael Levin-Epstein, Editor-in-Chief, FDLI, (202) 222-0897; [email protected]
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SOURCE Food and Drug Law Institute