Most study participants understand research goals
NEW YORK (Reuters Health) - People who take part in clinical trials often do so out of a desire to advance scientific knowledge and to help others, a new international study demonstrates.
"These results indicate that it is possible for patient participants, even those seeking treatment for a life-threatening illness, to recognize and embrace the goals of the research in which they participate," Dr. David Wendler of the National Institutes of Health in Bethesda, Maryland and colleagues conclude.
Wendler decided to conduct this study, he told Reuters Health, based on concerns that participants in clinical research are being exploited. "The worry is that researchers take advantage of people in desperate situations in order to get them into studies and do research with them," he explained. "It's a real worry." Critics have also said that these individuals may not understand that they are participating in a study intended to answer a scientific question and help others with their disease.
To investigate whether this is in fact the case, Wendler and his colleagues surveyed 582 HIV-positive people from Argentina, Brazil and Thailand who were participating in a clinical trial comparing antiretroviral drugs alone to antiretroviral drugs plus interleukin 2 (IL-2), a protein associated with the immune system. They had been taking part in the trial for 2.5 years, on average.
When asked to state "the single most important reason" for why they continued to participate in the study, obtaining medical or personal benefit topped the list, while a wish to make a contribution to science came in second.
Among the 292 people in the IL-2 arm of the study, most said increasing the number of key immune system T cells was the most important reason for continuing in the study, followed by finding better HIV treatments for patients in their country.
"Receiving IL-2" was the third most popular choice. In the non-IL-2 group, the top choice was finding effective treatments for HIV-positive people in their country, followed by finding HIV treatments for people in other countries and boosting their T cell counts.
Nine out of 10 of the study participants said they felt they were making a contribution to society, while 84 percent said they felt proud of this contribution.
"AIDS patients probably tend to be much more aware of the importance of research, the sense of the community of other AIDS patients and wanting to contribute to it," Wendler noted.
The current findings address just one study with one type of illness, the researcher added, so they can't be seen as showing that people are never exploited in clinical trials. However, Wendler said, the findings do provide "proof of principle" that "it's at least possible to conduct a study where you don't take advantage of patients with a serious illness in that way."
He and his colleagues did find that 3 percent of people in the IL-2 arm and 1 percent of those in the non-IL-2 arm defined themselves as "guinea pigs," or said they were "being used inappropriately."
"Some individuals can feel exploited even when the vast majority of participants embrace the goals of the study and express pride regarding their role," the researchers write.
"Future research should consider what steps investigators can take to help patient participants recognize and embrace the goals of the research in which they participate and address any concerns regarding exploitation," they suggest.
SOURCE: Archives of Internal Medicine, June 23, 2008.
