Friday, April 4, 2008

Trial participants not overly concerned by researchers' financial interests in trials
By Kelly Winget

Whether or not a researcher has a financial interest in a study doesn't influence a patient's willingness to participate in the study as much as the potential risks or benefits of the proposed treatment, according to a new study led by DCRI researchers.

In the new study, led by Kevin Weinfurt, Ph.D., deputy director of the DCRI's Center for Clinical and Genetic Economics, participants were asked to rate different types of financial disclosures for researchers, as well as other factors that impact their decision to participate in clinical trials. While most participants rated most types of financial disclosure as less important, patients had different reactions if they knew researchers could lose or gain money based on the outcome of the study.

The study findings were published online in the April 2 edition of the Journal of General Internal Medicine . Researchers surveyed more than 3,600 patients with diabetes or asthma, who were asked questions about their willingness to participate in a hypothetical clinical trial. Each survey had one of five possible financial disclosure statements.

The disclosure statements ranged from generic statements that the doctor running the trial might benefit financially to specific statements that addressed per capita payments and ownership of equity for the researcher or institution. This last statement indicated that the trial leader could gain or lose money depending on the outcome of the study.

Approximately 30 percent of participants who received the most specific disclosure statement in the survey said they would be unwilling to participate in the trial. When presented with a generic disclosure statement, only 25 percent said they would not want to participate. That amount dropped to 20 percent when participants were told that the lead researcher would receive payments from industry sources to cover the cost of running the trial.

Researchers concluded that participants felt ownership of equity might have an impact on the researcher's behavior during the trial.

Apart from evaluating willingness to participate in a trial based on financial disclosures, the research team also rated the reactions of study participants for their level of surprise, confidence in the quality of the research and trust of the researcher and institution.

Approximately one-third of the participants said the financial disclosures made them trust the researcher and the institution less, although that didn't always correlate with an unwillingness to participate in the trial.

Researchers said additional studies would be needed to further explore a researcher's financial interests and a perceived lack of trust by participants. This will be important as relationships between researchers and industry continue to change, said Weinfurt. Some organizations, such as the Department of Health and Human Services, have asked scientific and medical communities to evaluate if disclosing financial relationships between investigators and industry during the patient consent process would help better protect patient rights.

This study was one of several conducted as part of the Conflict of Interest Notification Study.

Other DCRI researchers include Michaela Dinan, Ph.D., Venita DePuy, Joelle Friedman and Jennifer Allsbrook.