Views of Cancer Patients Regarding Financial Conflicts of Interest

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Completed

CT.gov ID

NCT00097682

Collaborator

(none)

300

Enrollment

Locations

34.4

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Neoplasms

Detailed Description

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.

Study Design

Study Type:

Observational

Official Title:

Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research

Study Start Date :

Nov 18, 2004

Study Completion Date :

Oct 2, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Subjects will be included if they:

Have consented to participate in a phase I, I/II, II, or III cancer study and are at any point in that study.
Give informed consent.
Understand written and spoken English.
Are over 18 years of age.

EXCLUSION CRITERIA:

None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Denver	Colorado	United States	80220-3706
2	Yale University	New Haven	Connecticut	United States	06510-8005
3	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
4	Columbia University	New York	New York	United States	10032-3784
5	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	28104