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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01485250
First received: November 30, 2011
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

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.

Condition
Healthy Participants

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1200
Study Start Date: February 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485250

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Christine Grady, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01485250     History of Changes
Other Study ID Numbers: 999910061, 10-CC-N061
Study First Received: November 30, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers
Motivations
Motivation

ClinicalTrials.gov processed this record on April 17, 2014