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Clinical trial volunteers mostly indifferent -- but not blind to -- researchers' financial conflicts
Date:4/4/2008

the recruits, almost all white, were well educated and had middle to high income levels. They were located in all regions of the United States.

Most of the respondents indicated that the financial disclosure was less important to their decision about participating than such factors as potential risks and benefits, and the purpose of the research.

In the computerized experiment, the investigators electronically sent each patient a description of a hypothetical clinical trial to test a drug that might treat their particular condition. The recipients were grouped by the severity of their illnesses.

Tagged onto the description of the clinical trial was one of five different financial disclosures: a generic one suggesting that the study leader might benefit financially from the study; one saying that the study leader would be reimbursed only for expenses pertaining to the trial; one indicating that the study leader receives extra money from the drug company for activities such as consulting or speaking; one indicating that the study leader holds stock in the drug company; or one indicating that the researchers institution holds stock in the drug company.

The generic disclosure, for example, said that the researchers institution had reviewed Dr. Smiths financial conflict and concluded that it would not affect the safety or outcome of the clinical trial, but offered to provide more information if the participant wanted it.

The equity disclosure said that the amount of financial investment of Dr. Smith might be affected by the outcome of the clinical trial and that in effect, Dr. Smith could gain or lose money depending on what the trial concluded.

The patients were asked to read the material then respond to a computer-based survey indicating their willingness to participate in the trial, the importance of the financial disclosure in making their decision, their trust in researchers, their level of surprise about t
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Contact: Christen Brownlee
cbrownlee@jhmi.edu
410-955-7832
Johns Hopkins Medical Institutions
Source:Eurekalert

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