A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01485250

Enrollment

1278

Registered

2011-12-05

Start date

2010-02-19

Completion date

2018-08-08

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteers, Motivations, Decision Making, Motivation

Brief summary

Background: * Individuals often participate in clinical trials to seek new therapies and free medical treatments for their illnesses or chronic conditions. However, less is known about the motivations of the healthy individuals who volunteer for research studies. * Although many healthy volunteers participate in clinical trials for financial compensation, the particular risks involved in testing drugs that have not been tried in human clinical trials pose potential dangers for healthy volunteers in Phase I studies. More research is needed to understand the motivations of volunteers who participate in Phase I clinical trials. Objectives: \- To evaluate the primary and secondary motivations of healthy participants in research studies. Eligibility: \- Individuals at least 18 years of age who are healthy volunteers in selected Pfizer Phase I clinical trials. Design: * Individuals who express interest in participating in specific Pfizer Phase I drug studies will be asked to complete a short questionnaire after completing the standard consent session for the study. * Those who enroll in the trial will be asked to complete a second questionnaire prior to discharge from the study.

Detailed description

This healthy volunteer motivation study is a sub-study of Phase I drug development studies conducted by Pfizer International. The substudy is designed to evaluate the primary and secondary motivations of healthy participants in research studies, as well as the process by which participants decide to participate, including their consideration of any risks, benefits, compensation and other factors, and the relationship of these factors to cultural and sociodemographic variables. Data will be collected via self-administered surveys at 2 possible time points, 1) after going through the consent process at the beginning of participation in the primary study, and 2) towards the end of the study participation.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* INCLUSION CRITERIA: Participants will be willing adults who have participated in an informed consent session for a designated Phase I study at a Pfizer CRU. Participants in New Haven and Singapore must be able to read and answer question in English and participants in Brussels must be able to read and answer questions either in English, French, or Flemish. Only adults (over 18 years old) who can provide their own consent will be included.

Exclusion criteria

Participants in Pfizer phase I studies who are unable or unwilling to complete the survey instruments.

Countries

Belgium, Singapore, United States

Outcome results