NCT00097682

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2004

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2007

Completed
Last Updated

July 2, 2017

Status Verified

October 2, 2007

First QC Date

November 24, 2004

Last Update Submit

June 30, 2017

Conditions

Keywords

Financial TiesInstitutionResearch DoctorOncologyAttitudesCancerSurvey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Cancer Center

Denver, Colorado, 80220-3706, United States

Location

Yale University

New Haven, Connecticut, 06510-8005, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Columbia University

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

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 28104, United States

Location

Related Publications (1)

  • Kelch RP. Maintaining the public trust in clinical research. N Engl J Med. 2002 Jan 24;346(4):285-7. doi: 10.1056/NEJM200201243460413. No abstract available.

    PMID: 11807156BACKGROUND

MeSH Terms

Conditions

NeoplasmsBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

November 18, 2004

Study Completion

October 2, 2007

Last Updated

July 2, 2017

Record last verified: 2007-10-02

Locations