- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01485250
A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium
- Pfizer CRU
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Singapore, Singapore
- Pfizer CRU
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- Cunny KA, Miller HW. Participation in clinical drug studies: motivations and barriers. Clin Ther. 1994 Mar-Apr;16(2):273-82; discussion 271-2.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 999910061
- 10-CC-N061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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