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

NCT01485250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1278

Last updated 2019-12-17

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Christine Grady, M.D. · National Institutes of Health Clinical Center (CC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-19
Completion
2018-08-08

Countries

  • United States
  • Belgium
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485250 on ClinicalTrials.gov