Clinical trial NCT01485250: A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
Official title: A Cross-Cultural Assessment of the Motivations of Healthy Participants in Phase I Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteer
Keywords: Healthy Volunteers
Motivations
Decision Making
Motivation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-12-05
Enrollment: 1278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

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.

Eligibility criteria: * 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
city: Brussels
country: Belgium
facility: Pfizer CRU
city: Singapore
country: Singapore
facility: Pfizer CRU
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Christine Grady, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Cunny KA, Miller HW. Participation in clinical drug studies: motivations and barriers. Clin Ther. 1994 Mar-Apr;16(2):273-82; discussion 271-2.