Views of Cancer Patients Regarding Financial Conflicts of Interest

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097682
• Other study ID #: 050038
• Secondary ID: 05-CC-0038
• Status: Completed
• Phase: N/A
• First received: November 24, 2004
• Last updated: June 30, 2017
• Start date: November 18, 2004
• Est. completion date: October 2, 2007

Study information

• Verified date: October 2, 2007
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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:

Related Conditions & MeSH terms

• Neoplasms

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Yale University	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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