Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research

Abstract

Background/aim: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns. This study aims to describe the socio-demographic characteristics, motivations, and enrollment decision-making of a large cohort of healthy volunteers.

Methods: We used a cross-sectional anonymous survey of 1194 healthy volunteers considering enrollment in phase 1 studies at Pfizer Clinical Research Units in New Haven, CT; Brussels, Belgium; and Singapore. Descriptive statistics describe motivations and socio-demographic characteristics. Comparisons between groups were examined.

Results: The majority rated consideration of risks as more important to their enrollment decision than the amount of money, despite reporting that their primary motivation was financial. Risk, time, money, the competence and friendliness of research staff, and contributing to medical research were important factors influencing enrollment decisions for most participants. The majority of healthy volunteers in this cohort were male, single, reported higher than high school education, and 70% had previous research experience. Many reported low annual incomes (50% below USD$25,000) and high rates of unemployment (33% overall). Nonetheless, risk as an important consideration, money, and other reported considerations and motivations, except for time, did not vary by income, employment, education, or previous experience. There were regional differences in both socio-demographic characteristics and factors important to participation decisions.

Conclusion: Healthy volunteers in phase 1 studies consider risks as more important to their enrollment decisions than the amount of money offered, although most are motivated to participate by the offer of money. Healthy volunteers are indeed low income, disproportionately unemployed, and have significant prior research experience. Yet these factors do not appear to affect either their motivations for participation or factors important to their research enrollment decisions.

Keywords: Healthy volunteers; financial incentives; motivations.

Figure 1.. Main motivations for the enrollment among healthy volunteer phase 1 Pfizer drug development participants.

Participants were asked to select the main reason for their participation. If a main reason could not be chosen, they were asked to rank the reasons. Those who chose only one or ranked a reason as first are included among the data presented as “first reason.” The data are also shown by indication of any importance (either as primary choice or a lower rank).

Figure 2.. Responses to trade-off questions as reported by healthy volunteers participating in phase 1 Pfizer drug development studies.

Participants were asked to indicate which of the trade-off factors was more important to their decision on whether or not to join the study. The percent of responses are shown for each pair of factors included in the survey. Money = “The amount of money offered” Procedures = “The number and type of painful procedures” Helping future patients = “How much the study helps future patients” Type of drug = “The type of drug (e.g. psychiatric, blood pressure, etc.)” Risks and side effects = “Possible risks and side effects from study medications” Time = “The amount of time I would have to spend at the Pfizer CRU”