A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2019 |
| Start Date: | February 19, 2010 |
| End Date: | August 8, 2018 |
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.
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.
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.
- 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.
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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