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

ABSTRACT:

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 Pha

SUBMITTER: Fisher JA 

PROVIDER: S-EPMC6245523 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature