Views of Cancer Patients Regarding Financial Conflicts of Interest

• ClinicalTrials.gov Identifier: NCT00097682
• Recruitment Status: Completed
• First Posted: November 25, 2004
• Last Update Posted: July 2, 2017
• Sponsor: National Institutes of Health Clinical Center (CC)
• Information provided by: National Institutes of Health Clinical Center (CC)

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
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
• Enrollment: 300 participants
• Official Title: Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research
• Study Start Date: November 18, 2004
• Study Completion Date: October 2, 2007

Groups and Cohorts

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

• 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:

None.

Contacts and Locations

Locations

United States, Colorado

University of Colorado Cancer Center

Denver, Colorado, United States, 80220-3706

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06510-8005

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

United States, New York

Columbia University

New York, New York, United States, 10032-3784

United States, Washington

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 28104

Sponsors and Collaborators

National Institutes of Health Clinical Center (CC)

More Information

Publications:

Kelch RP. Maintaining the public trust in clinical research. N Engl J Med. 2002 Jan 24;346(4):285-7.

• ClinicalTrials.gov Identifier: NCT00097682
• Other Study ID Numbers: 050038; 05-CC-0038
• First Posted: November 25, 2004
• Last Update Posted: July 2, 2017
• Last Verified: October 2, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):

Financial Ties; Institution; Research Doctor; Oncology; Attitudes; Cancer; Survey