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临床试验/NCT01485250
NCT01485250已完成不适用

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

National Institutes of Health Clinical Center (CC)2 个研究点 分布在 2 个国家目标入组 1,278 人开始时间: 2010年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,278
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (2)

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