نبذة مختصرة : Background There is limited research on healthy volunteers’ perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers’ involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to investigate (1) participants’ views of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a trial, and (3) how risk perceptions vary across participants’ clinical trial history and sociodemographic characteristics. Methods and findings We qualitatively and quantitatively analyzed semi-structured interviews conducted with 178 healthy volunteers who had participated in a diverse range of Phase I trials in the United States. Participants had collective experience in a reported 1,948 Phase I trials (mean = 10.9; median = 5), and they were interviewed as part of a longitudinal study of healthy volunteers’ risk perceptions, their trial enrollment decisions, and their routine health behaviors. Participants’ qualitative responses were coded, analyzed, and subsequently quantified in order to assess correlations between their risk perceptions and demographics, such as their race/ethnicity, gender, age, educational attainment, employment status, and household income. We found that healthy volunteers often viewed the overall risks of Phase I trials differently than their own personal risk of harm. The majority of our participants thought that Phase I trials were medium, high, or extremely high risk (118 of 178), but most nonetheless felt that they were personally safe from harm (97 of 178). We also found that healthy volunteers in their first year of clinical trial participation, racial and ethnic minority participants, and Hispanic participants tended to view the overall trial risks as high (respectively, Jonckheere-Terpstra, −2.433, p = 0.015; Fisher exact test, p = 0.016; Fisher exact test, p = 0.008), but these groups did not differ in regard to their perceptions of personal risk of harm (respectively, chi-squared, 3.578, p = 0.059; chi-squared, 0.845, p = 0.358; chi-squared, 1.667, p = 0.197). The main limitation of our study comes from quantitatively aggregating data from in-depth interviews, which required the research team to interpret participants’ nonstandardized risk narratives. Conclusions Our study demonstrates that healthy volunteers are generally aware of and reflective about Phase I trial risks. The discrepancy in healthy volunteers’ views of overall and personal risk sheds light on why healthy volunteers might continue to enroll in clinical trials, even when they view trials on the whole as risky.
Jill A. Fisher and colleagues use mixed-methods analysis of 178 interviews to discover how US Phase I trial participants assess their personal risk when they choose to volunteer.
Author summary Why was this study done? The purpose of this study was to better understand how healthy volunteers perceive the risks of enrolling in Phase I clinical trials. These trials offer healthy volunteers no direct medical benefit for their participation, but participants are financially compensated. Ethical concerns regarding undue inducement—or that the offer of substantial amounts of money may distort healthy volunteers’ risk perceptions and encourage them to enroll—have long been associated with Phase I trials because participants are typically underemployed and disproportionately members of minority groups. Little empirical research has explored how individuals participating in Phase I trials describe the risks. What did the researchers do and find? We conducted interviews with 178 healthy volunteers who had experience participating in a variety of US Phase I trials. We asked questions about their perceptions of trial risks, how they decide to enroll in such trials, and their everyday health-related activities. We took a mixed-methods approach to analyzing participants’ interview data to find qualitative themes in how they described Phase I risks and quantitative differences in how groups of healthy volunteers differed from each other. Our main finding was that healthy volunteers often distinguished the overall risks of Phase I trials from their own personal risk of harm: many saw trials in general to be highly or moderately risky, while feeling they were unlikely to be harmed personally. We also found that healthy volunteers who were new to clinical trial participation and minority participants, particularly Hispanics, tended to view the overall risks of trials as higher compared with those who had participated in clinical trials for a longer time and non-Hispanic whites. What do these findings mean? This study sheds light on how Phase I trial risks are understood by diverse healthy volunteers with a range of trial experiences. Many healthy volunteers hold the incongruous view that Phase I trials overall carry significant risk but that they are nevertheless personally safe from harm. This provides some indication of undue inducement in Phase I trials, given that healthy volunteers, particularly those who are new to clinical trials or members of minority groups, engage in improbable narratives of personal exemption from risk of harm when justifying their participation in what they typically see as a risky activity. Phase I investigators should question the extent to which recruitment and informed consent processes can address the gap between how healthy volunteers think about overall trial risks and their potential to be personally harmed in studies.
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