Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 2:40 PM
Study NCT ID:
NCT01485250
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
Status:
COMPLETED
Status Verified Date:
2018-08-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-CC-N061 | None | None | View |