Views of Cancer Patients Regarding Financial Conflicts of Interest

June 30, 2017 updated by: National Institutes of Health Clinical Center (CC)

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220-3706
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510-8005
        • Yale University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10032-3784
        • Columbia University
    • Washington
      • Seattle, Washington, United States, 28104
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 18, 2004

Study Completion

October 2, 2007

Study Registration Dates

First Submitted

November 24, 2004

First Submitted That Met QC Criteria

November 24, 2004

First Posted (Estimate)

November 25, 2004

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

October 2, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 050038
  • 05-CC-0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe