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

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.

Speculating on Precarious Income: Finance Cultures and the Risky Strategies of Healthy Volunteers in Clinical Drug Trials.

Speculation has become a normalized occupational strategy and quotidian economic rationality that extends throughout society. Although there are many contemporary articulations of speculation, this article focuses on contract labor as a domain of financialization. Seen through this lens, contract labor can be understood as a speculative investment strategy wherein individuals leverage whatever assets they have at their disposal-savings, time, bodily health-to capture economic advantages. In particular, we explore the speculative practices of healthy individuals who enroll in pharmaceutical drug trials as their primary or critical source of income. Mobilizing speculative logics to maximize the money they can earn from their clinical trial participation, these contract workers employ what we term a future-income-over-immediate-pay calculus. This speculative calculus valorizes fictional projections of significant long-term future income over present financial opportunities. For the economically precarious individuals in our study, we argue that rather than effectively increasing their income, speculation on contract work serves a compensatory function, providing an important-but ultimately inadequate-sense of control over market conditions that thrive upon workers' economic insecurity.

Healthy Volunteers' Perceptions of the Benefits of Their Participation in Phase I Clinical Trials.

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants' sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants' perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

Hypersensitivity reactions to titanium: diagnosis and management.

Titanium is notable for its biocompatibility and is used as biologic implant material across surgical specialties, especially in metal-sensitive individuals. However, rare cases of titanium hypersensitivity reactions are reported in the literature. This article discusses the properties and biological behavior of titanium and provides a thorough review of the literature on reported cases, diagnostic techniques, and approach to management of titanium hypersensitivity.

Spectral Doppler signature waveforms in ultrasonography: a review of normal and abnormal waveforms.

Doppler ultrasound is routinely used in the clinical setting to evaluate blood flow in many major vessels of the body. Spectral Doppler is used to display the normal and abnormal signature waveforms that are unique to each vessel. It is important for the sonographer and the radiologist to recognize both what is normal and what is abnormal in a spectral Doppler display. In this review, we briefly explain the physics behind Doppler ultrasound and some of the most common mathematical equations applied in a routine clinical examination. We also describe and demonstrate normal versus abnormal spectral Doppler signature waveforms of vessels in the neck, abdomen, pelvis, and fetus.