Transcript 6. Cleveland Clinic COI Presentation

Conflict of Interest in Human
Subjects Research
Guy M. Chisolm, III, Ph.D.
Vice Chair, Lerner Research Institute
Cleveland Clinic
Presentation to the
Secretary’s Advisory Committee on Human Research
Protections
SACHRP
Arlington, Virginia
July 22, 2009
CoI Topics and Issues
• Means of uniform public disclosure
• Educating the public on CoI
• Determining the effectiveness of CoI
Management
• Giving guidance for disposition of CoI in
human subjects research
“Reporting” versus “Disclosing”
Public Disclosure Websites
• Feds -- US Att’y Gen’l’s settlement with 5 device mfgrs
• Feds -- Grassley & Kohl’s “Sunshine Act”
• States -- Minnesota, Massachusetts, Vermont…
• Companies -- Eli Lilly, Merck, Pfizer, Edwards, GSK,
Medtronic,…others
• AMCs -- Cleveland Clinic (went live, 10/28/08)
Univ of Pennsylvania, Stanford,…others
(pending)
Go to www.clevelandclinic.org …
Click on ‘FIND A DOCTOR…
Guy Chisolm, Ph.D.
Professional Staff Affairs Office
Director, Innovation Management and Conflict of Interest Program
Cell Biology
Staff/Professor
Lerner Research Institute
Vice Chair
Phone: (216) 444-5854
Location:
Cleveland Clinic Main Campus
Mail Code NB21
9500 Euclid Avenue
Cleveland, OH 44195
* Brief Biosketch
* Education & Fellowships
* Specialty Interests
* Research & Publications
* Request an Appointment
* Industry Relationships
Education & Fellowships
Fellowship:
Fellowship:
Other Education:
Other Education:
Other Education:
Karolinska Institute, Stockholm, Sweden
Massachusetts Institute of Technology, Cambridge, MA
(Doctorate) University of Virginia, Charlottesville, VA
(Masters) University of Virginia, Charlottesville, VA
(Undergraduate) University of Pennsylvania, Philadelphia, PA
Specialty Interests
Lipoprotein oxidation, vascular diseases, lipoprotein-cell interactions, atherosclerosis.
Research & Publications
[Click through to PubMed]
Industry Relationships
Cleveland Clinic physicians and scientists report if they have any collaborations with the
pharmaceutical or medical device industries as part of the Cleveland Clinic’s procedures. The
Cleveland Clinic publicly discloses payments for speaking and consulting of $5,000 or more per
year, and any equity, royalties, and fiduciary relationships in companies with which they
collaborate. In publicly disclosing this information, the Cleveland Clinic tries to provide information
as accurately as possible about its doctors’ connections with industry and those of their immediate
family members. As of 6/26/2008, Dr. Chisolm has reported no financial relationship with industry
that is applicable to this listing. Patients should feel free to contact their doctor about relationships
with industry and how the relationships are overseen by the Cleveland Clinic. To learn more about
the Cleveland Clinic’s policies on collaborations with industry and innovation management, go to
our Integrity in Innovation page.
Consulting. Dr. Chisolm receives fees of $5,000 per year or more as a paid consultant or
speaker for the following companies:
None listed
Royalty Payments. Dr. Chisolm has the right to receive royalty payments for inventions
or discoveries related to the companies shown below:
None listed
Equity. Dr. Chisolm owns stock or stock options from the following companies for
activities as a founder, inventor, or consultant:
None listed
Fiduciary Role. Dr. Chisolm serves in a fiduciary capacity, such as an officer or director,
for the following companies:
None listed
Inventor Share. Dr. Chisolm may receive future financial benefits from the Clinic for
inventions or discoveries related to the companies shown below:
None listed
CoI Disclosure Website Working Group Cleveland Clinic, March 27, 2009
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•
•
Host:
Moderator:
State
Government:
Guy M. Chisolm, Ph.D.
Susan Ehringhaus, J.D.
James Daniel, MPH
Cleveland Clinic
AAMC
State of Massachusetts
•
Device
Industry:
Christopher White, Esq.
Bruce P. Garren
Kathy E. DiGiorno
AdvaMed
Edwards Lifesciences Corp
Medtronic
•
Pharma
Industry:
Jack Harris, M.D.
Geralyn S. Ritter
Cathryn M. Clary, M.D., MBA
Jeffrey Paden
Eli Lilly
Merck & Co., Inc.
Pfizer, Inc.
GSK
•
Public AMCs:
Raymond Hutchinson, M.D.
Deborah Biggs, J.D.
Neal Cohen, M.D., MPH, MS
Barry D. Burgdorf, J.D.
Lynn Zentner
University of Michigan Medical School
UNC Chapel Hill School of Medicine
UCSF School of Medicine
The University of Texas System
University of Minnesota
•
Private
AMCs:
Ross McKinney, M.D.
Claudia Adkison, JD, PhD
Julie Gottlieb, M.A.
Marianne Hockema
Christopher Clark, J.D.
Glen Gaulton, Ph.D.
Harry Greenberg, M.D.
Duke University School of Medicine
Emory University School of Medicine
Johns Hopkins University School of Medicine
Mayo Clinic
Partners Health Care (B&W, MGH, Harvard)
University of Pennsylvania School of Medicine
Stanford University School of Medicine
What we learned from convening entities
planning web-based disclosure
It is very clear that over the next two years there
will be multiple websites for disclosure set up by
the federal government, state governments,
companies and academic medical centers that
disclose industry relationships of physicians in
various and non-uniform fashion.
Discrepancies are inevitable!
Patient Survey--Preliminary Results
Objective
• To gauge patient perceptions of conflicts of interest due to
physician relationships with industry
Methods
• Online survey of the Cleveland Clinic Patient Panel
• Cleveland Clinic Patient Panel -- current patients of
Cleveland Clinic who volunteer to assist the organization
by participating in surveys that address topics related to
healthcare.
Study
Survey Timeline
Panel Members Invited
Completed Surveys
Completion Rate
Median Survey Time
Participation Incentive
Study Description
June 19, 2009 – June 24, 2009
2,319
1,153 to date
49.7% to date
9 minutes
Raffle of (25) $50 USD Checks
Preliminary Results: Familiarity with CoI
• How familiar are you with the meaning of
the term Conflict of Interest as it relates to
health care institutions and physicians?
Preliminary Results: Seeking Industry
Relationship Information
• If it was available online, how likely would you be
to seek information about the industry
relationships of your past, current or potential
physicians?
Information of Interest
• What information do you want to know
about your Cleveland Clinic physician’s
relationships with business?
Preliminary Results: Further Disclosure Wanted
• What information about your physician’s business
relationships do you feel is missing that you’d like to
know?
(Most common answers paraphrased)
– Amounts of money
– Other perks (vacations, gifts, meals,…)
– Impact on patient treatment
– Whether physician’s friends or family members are linked to the
businesses
– How long these relationships have been in existence
– How much of the physician’s time is spent devoted to outside
business activities
Limitations of Patient Panel Method
• Results represent Cleveland Clinic Health
System (Main Campus, Family Health
Center and/or Regional Hospital) patients
only,…
• NOT the general population.
• The pre-existing patient-clinic relationship
has likely affected the opinions in this
report.
What we learned from asking our patients
about physician-industry ties that is likely
pertinent to research subjects
It is clear that patients and their families
(arguably a similar population to those typically
asked if they would volunteer to be research
subjects) want much more information than
they have.
Issue--Uniform Public Disclosure
• Means of uniform public disclosure
While disclosure is endorsed by all, and the public
is hungry to know more, the non-uniformities in the
making will confuse research subjects and their
families rather than help them
• Recommendation--Encourage broad public
disclosure, but determine template for uniformity
and in best interests of research subjects, patients,
public
CoI Topics and Issues
• Means of uniform public disclosure
• Educating the public on CoI
• Determining the effectiveness of CoI
Management
• Giving guidance for disposition of CoI in
human subjects research
Issue--Educating the Public on CoI
• Educating the public on CoI
The public does not clearly recognize benefits of
industry-academic partnerships in research, how
these must be balanced against risks of bias from
CoI, and how these are being evaluated and
processed.
• Recommendation--Determine means to educate
the public of the benefits of academic-industry
partnerships in research, the CoI risks and “best
practices” for effective CoI management
CoI Topics and Issues
• Means of uniform public disclosure
• Educating the public on CoI
• Determining the effectiveness of CoI
Management
• Giving guidance for disposition of CoI in
human subjects research
Cleveland Clinic Conflict of Interest Policies
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•
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Conflicts of Commitment
CoIs in Business Affairs
Non-Human Subjects Research
Human Subjects Research
Institutional CoIs in Research
Consulting
[Clinical Practice]
[Education]
© The Cleveland Clinic Foundation 2009
Institutional CoI in Research
– Financial interests of Cleveland Clinic
– Financial interests of CC’s leaders
• (Department Chairs or higher; Trustees)
What are we looking for in CoI evaluation?
(SIGNIFICANT FINANCIAL INTEREST)
Are you receiving from an outside entity…
 equity, stocks (options), “inventor share”
 royalties
 consulting or speaker fees > $10,000/yr
(ACTIVITY)
…while you are …
 performing research related to that entity
 making business decisions related to that entity
 (practicing medicine related to that entity)
 (educating trainees)
To get “approval” to perform human subjects research
related to a company and have a financial interest
in the company, you need…
– Compelling circumstances (AAMC guidelines)
•
•
•
•
•
These vary among institutions (!)
Inventor--understanding the value of development
Low risk to human subjects
Unique capability/expertise
Patient population without options
– A CoI Management Plan
• Separate the influence of the money from the patient care and
the research data
(disclosure!!!; data analysis; patient selection; patient consent;
multi-center; alternate principal investigator; external data &
safety monitoring; no phase III, etc…)
© The Cleveland Clinic Foundation 2009
Issue--Effectiveness of CoI Management
• Determining the effectiveness of CoI Management
AMCs are quickly developing the infrastructure and
processes to identify and evaluate CoI, then
eliminate, reduce or manage them. This is being
done with only inferential reliance on the
effectiveness of these endeavors.
• Recommendation-- Promote research that
addresses the effectiveness of current “best
practices” in overseeing/managing CoI
CoI Topics and Issues
• Means of uniform public disclosure
• Educating the public on CoI
• Determining the effectiveness of CoI
Management
• Giving guidance for disposition of CoI in
human subjects research
Issue--Common rules for CoI in human research
• Giving guidance for disposition of CoI in
human subjects research
AMCs are non-uniform in the application of
multiple CoI guidelines to human subjects
research. (Discussed by Dr. McKinney)
• Recommendation-- (quoting Dr. McKinney…)
Develop a “common rule” for CoI in clinical
research [NIH, FDA, OHRP, DOD, etc.]
Recommendations
• Encourage broad public disclosure, but determine
template for uniformity and in best interests of
research subjects, patients, public
• Determine means to educate the public of the benefits
of academic-industry partnerships in research, the CoI
risks and effective CoI management
• Promote research that addresses the effectiveness of
current “best practices” in overseeing/managing CoI
• (McKinney…) Develop a “common rule” for CoI in
clinical research [NIH, FDA, OHRP, DOD, etc.]