Views of Cancer Patients Regarding Financial Conflicts of Interest

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00097682
First received: November 24, 2004
Last updated: March 5, 2008
Last verified: October 2007
  Purpose

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
Neoplasms

Study Type: Observational
Official Title: Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097682

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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00097682     History of Changes
Other Study ID Numbers: 050038, 05-CC-0038
Study First Received: November 24, 2004
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Financial Ties
Institution
Research Doctor
Oncology
Attitudes
Cancer
Survey

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 08, 2014