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

NCT ID: NCT01485250

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-19

Study Completion Date

2018-08-08

Brief Summary

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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

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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.

Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteers Motivations Decision Making Motivation

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Grady, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Pfizer CRU

Brussels, , Belgium

Site Status

Pfizer CRU

Singapore, , Singapore

Site Status

Countries

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United States Belgium Singapore

References

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Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation? Eur J Clin Pharmacol. 2007 Nov;63(11):1085-94. doi: 10.1007/s00228-007-0368-3. Epub 2007 Sep 20.

Reference Type BACKGROUND
PMID: 17891536 (View on PubMed)

Bigorra J, Banos JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443-6. doi: 10.1007/BF02336681.

Reference Type BACKGROUND
PMID: 2379528 (View on PubMed)

Cunny KA, Miller HW. Participation in clinical drug studies: motivations and barriers. Clin Ther. 1994 Mar-Apr;16(2):273-82; discussion 271-2.

Reference Type BACKGROUND
PMID: 8062322 (View on PubMed)

Other Identifiers

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10-CC-N061

Identifier Type: -

Identifier Source: secondary_id

999910061

Identifier Type: -

Identifier Source: org_study_id