NeoplasmsNCT00097682
Views of Cancer Patients Regarding Financial Conflicts of Interest
An observational study of Neoplasms, run by National Institutes of Health Clinical Center (CC) at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Nov 2004to 2 Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Colorado Cancer Center
Denver, Colorado, 80220-3706
Yale University
New Haven, Connecticut, 06510-8005
Columbia University
New York, New York, 10032-3784
Fred Hutchinson Cancer Research Center
Seattle, Washington, 28104
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Neoplasms
- Keywords
- Financial Ties, Institution, Research Doctor, Oncology, Attitudes, Cancer, Survey
- Medical subject headings
- Neoplasms, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study start18 Nov 2004
- Study completion2 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097682
- Sponsor's protocol ID
- 050038
- Other IDs
- 05-CC-0038
- Status last verified
- 2 Oct 2007
- First submitted
- 24 Nov 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 11807156
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Study to Understand the Views of Cancer Patients Regarding Financial Conflicts of Interest in Research
- ClinicalTrials.gov ID
- NCT00097682
- Acronym / sponsor ID
- 050038
- Conditions
- Neoplasms
- Keywords
- Financial Ties, Institution, Research Doctor, Oncology, Attitudes, Cancer, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 18 Nov 2004
- Study completion
- 2 Oct 2007
- First posted
- 25 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11807156Kelch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by National Institutes of Health Clinical Center (CC) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.