Healthy volunteers' perceptions of risk in US Phase I clinical trials: A mixed-methods study.

Autor: Fisher JA; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., McManus L; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.; Department of Sociology and Anthropology, North Carolina State University, Raleigh, North Carolina, United States of America., Cottingham MD; Department of Sociology, University of Amsterdam, Amsterdam, the Netherlands., Kalbaugh JM; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., Wood MM; Department of Communication, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., Monahan T; Department of Communication, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America., Walker RL; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
Jazyk: angličtina
Zdroj: PLoS medicine [PLoS Med] 2018 Nov 20; Vol. 15 (11), pp. e1002698. Date of Electronic Publication: 2018 Nov 20 (Print Publication: 2018).
DOI: 10.1371/journal.pmed.1002698
Abstrakt: 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.
Competing Interests: The authors have declared that no competing interests exist.
Databáze: MEDLINE
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