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Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake, Food and Drug Law Journal Article Finds
Date:12/18/2007

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; mdl@fdli.org

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field. For more information, visit http://www.fdli.org


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