Views of Cancer Patients Regarding Financial Conflicts of Interest
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2004 |
| End Date: | October 2007 |
Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research
This study will explore what research patients understand about financial collaborations in
the research setting and their concerns about these collaborations. Financial partnerships
are crucial to advancing medical research; however, they are giving rise to increasing
concerns about financial conflicts of interest and possible impacts on the integrity of
research and patient safety. This study will examine patients' views about financial ties
between drug companies and the doctors running research studies, as well as ties between the
drug companies and the cancer centers where the studies are conducted.
Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer
Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the
Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert
Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in
Denver, CO, may be eligible for this study.
Participants are interviewed about the following:
- Patients' awareness and understanding about individual and institutional financial
conflicts of interest, and how such conflicts, if they exist, are being managed
- The impact of a researcher's financial ties on the patient's decision to participate in
that researcher's study
- The impact of the institution's financial ties on the patient's decision to participate
in research at that institution
- Attitudes about policies and practices regarding conflicts of interest in the research
setting
- Attitudes about disclosure of conflicts of interest in the research setting
- Patient symptoms and performance
- Patient's cancer trial
- Patient's cancer history
- Patient's trust
- Patient demographics (gender, age, race, religion, education, income, health insurance,
employment).
the research setting and their concerns about these collaborations. Financial partnerships
are crucial to advancing medical research; however, they are giving rise to increasing
concerns about financial conflicts of interest and possible impacts on the integrity of
research and patient safety. This study will examine patients' views about financial ties
between drug companies and the doctors running research studies, as well as ties between the
drug companies and the cancer centers where the studies are conducted.
Patients 18 years of age and older who are enrolled in cancer studies at the National Cancer
Institute in Bethesda, MD; the Fred Hutchinson Cancer Research Center in Seattle, WA; the
Dana-Farber Cancer Institute in Boston, MA; the Columbia Comprehensive University Herbert
Irving Cancer Center in New York, NY; and the University of Colorado Cancer Center in
Denver, CO, may be eligible for this study.
Participants are interviewed about the following:
- Patients' awareness and understanding about individual and institutional financial
conflicts of interest, and how such conflicts, if they exist, are being managed
- The impact of a researcher's financial ties on the patient's decision to participate in
that researcher's study
- The impact of the institution's financial ties on the patient's decision to participate
in research at that institution
- Attitudes about policies and practices regarding conflicts of interest in the research
setting
- Attitudes about disclosure of conflicts of interest in the research setting
- Patient symptoms and performance
- Patient's cancer trial
- Patient's cancer history
- Patient's trust
- Patient demographics (gender, age, race, religion, education, income, health insurance,
employment).
This study seeks to inform deliberation of ethical issues related to financial conflicts of
interest in clinical research through empirical data obtained from patients participating in
cancer studies. In particular, this study endeavors to describe and summarize the views of
patients about both individual and institutional financial conflicts of interest pertaining
to clinical research. This study will assess awareness of financial conflicts of interest
and the current safeguards in place to manage financial ties; assess the impact of
hypothetical financial conflicts of interest on a research subject's decision to participate
in a clinical study; identify the reasons that financial conflicts of interest either do or
do not influence patients' research participation; summarize views regarding the presence of
financial conflicts of interest and what limits should be in place to manage them; identify
interests about disclosure of these financial conflicts of interest; describe demographic
characteristics of subjects enrolled in the survey and evaluate the impact of demographic
information on subjects' views regarding financial conflicts of interest. Participants will
be recruited from all phases of oncology studies being conducted at 5 sites, the National
Cancer Institute in Bethesda, MD; the Dana-Farber Cancer Institute in Boston, MA; the Fred
Hutchinson Cancer Research Center in Seattle, WA; the University of Colorado Cancer Center
in Denver, CO, and the Columbia University Herbert Irving Comprehensive Cancer Center in New
York, NY. The primary methodology for the study is an in-person administration of a
questionnaire.
interest in clinical research through empirical data obtained from patients participating in
cancer studies. In particular, this study endeavors to describe and summarize the views of
patients about both individual and institutional financial conflicts of interest pertaining
to clinical research. This study will assess awareness of financial conflicts of interest
and the current safeguards in place to manage financial ties; assess the impact of
hypothetical financial conflicts of interest on a research subject's decision to participate
in a clinical study; identify the reasons that financial conflicts of interest either do or
do not influence patients' research participation; summarize views regarding the presence of
financial conflicts of interest and what limits should be in place to manage them; identify
interests about disclosure of these financial conflicts of interest; describe demographic
characteristics of subjects enrolled in the survey and evaluate the impact of demographic
information on subjects' views regarding financial conflicts of interest. Participants will
be recruited from all phases of oncology studies being conducted at 5 sites, the National
Cancer Institute in Bethesda, MD; the Dana-Farber Cancer Institute in Boston, MA; the Fred
Hutchinson Cancer Research Center in Seattle, WA; the University of Colorado Cancer Center
in Denver, CO, and the Columbia University Herbert Irving Comprehensive Cancer Center in New
York, NY. The primary methodology for the study is an in-person administration of a
questionnaire.
- INCLUSION CRITERIA:
Subjects will be included if they:
1. Have consented to participate in a phase I, I/II, II, or III cancer study and are at
any point in that study.
2. Give informed consent.
3. Understand written and spoken English.
4. Are over 18 years of age.
EXCLUSION CRITERIA:
We found this trial at
5
sites
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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