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Conflicts of Interest (In Clinical Research) Multidisciplinary Clinical Research Career Development Program University of Maryland February 28, 2008 Some Things to Think About Which aspects of a given situation constitute CoI? Which are directly financial and which are not?

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conflicts of interest in clinical research

Conflicts of Interest(In Clinical Research)

Multidisciplinary Clinical Research Career Development Program University of Maryland

February 28, 2008

some things to think about
Some Things to Think About
  • Which aspects of a given situation constitute CoI? Which are directly financial and which are not?
  • How can CoI affect the conduct of research? Of the scientific record?
  • What are the ramifications of CoI for scientists as researchers? As consumers of scientific information?
some more things to think about
Some More Things to Think About
  • What can scientists do to avoid the ramifications of CoI?
  • What regulations apply to CoI in research?
  • How is CoI in research routinely managed?
  • How should CoI in research be managed?
slide4

Conflict of Interest

Situation in which the integrity of academic activity, especially research, may be, or may be perceived to be, compromised by financial or other interests.

slide5

Perceived

Actual

vs

Conflicts of Interest

slide6

Baltimore Sun December 8, 2006

By Matthew Dolan

Government Scientist Pleads Guilty

Senior Alzheimer’s Researcher Admits

Taking $285,000 In Fees, Expenses

A senior government scientist working in Alzheimer’s disease research pleaded guilty today to accepting $285,000 in consulting fees and travel expenses from the world’s largest drug manufacturer without proper approval from his bosses.

As part of his agreement with federal prosecutors, Pearson “Trey” Sunderland III, chief of the geriatric psychiatry branch of the National Institute of Mental Health, which is part of the National Institutes of Health, will be sentenced to two years of supervised probation and must forfeit $300,000.

slide7

Conflicts of Interest

  • Most are financially based
  • Some are just accepted
    • Owning an hypothesis
    • Research results as proprietary information pending publication
    • Continuing research support
    • Developing intellectual property

R P Taleyarkhan

Woo Suk Hwang

slide9

Roles

Entrepreneur

Scientist

Produces data which may be built upon

Uses the scientific method

Rules out alternatives to an idea

Avoids risky approaches to a problem

Produces something marketable

Uses business development models

Develops support for an idea

Is comfortable accepting and managing risk

slide10

Similarities

Scientist

Entrepreneur

Reputation is a key asset

It’s all about gaining acceptance of a new idea

Passion for the enterprise is essential

slide11

Sources of Potential Conflict

  • Consultant
  • Speaker
  • Stock or Other Equity
  • Management Position
  • Income from Royalties or Licensing Fees
  • Board or Scientific Advisory Board Member
  • Gift
  • Relationship with Competitor
  • Loans (To or From)
  • Family Member has Relationship

Institutional vs Invididual CoI

slide12

Does conflict of interestpresent a legitimate concern?

Financial interests steer the academic activity to the point where it is compromised

Financial interest gives the appearance that the academic activity may be compromised

Maintaining full academic integrity would compromise the business plan and/or require excess resources

slide13

Science Gone Wrong

What’s the worst that could happen?

slide14

Jesse

Gelsinger

slide16

Examples of What We are Guarding Against

Deciding not to publish research results which would be harmful to the entity

Agreeing to develop a research protocol to the entity’s specifications

Falsifying or fabricating research results which would be beneficial to the entity

Conducting research which poses significant risk in order to develop a technology licensed by the University

slide17

Relationship betweenFunding Source and Conclusion amongNutrition-Related Scientific Articles

  • 111 of 206 articles declared financial sponsorship
    • 22% had all industry funding
    • 47% had no industry funding
    • 32% had mixed funding
  • Funding source was significantly related to conclusions for all article types (p=0.037)
    • Odds ratio of favorable to unfavorable conclusions for all industry funding vs no industry funding was 7.61
  • Interventional studies
    • 0% unfavorable conclusions for all industry funding
    • 37% unfavorable conclusions for no industry funding

Data from Lesser, et al. PLoS Medicine, Jan 2007, pp 0001-0006

slide19

Leaky Labs

From Hopkins Magazine (Fall, 2006)

slide20

Spectrum of Conflicts

minor

major

$$$ or Equity

Influence

Complexity

Sensitivity

slide22

Applicable Policies and Procedures

USM Policy On Conflicts of Interest In Research or Development

www.umaryland.edu/hrpolicies/section3/t30111sa.html

UMB Procedures Implementing Board of Regents Policy on COI…

www.ord.umaryland.edu/researchers/policies/umproceed.php

maryland public ethics law

Maryland Public Ethics Law

Code of Maryland Regulations

15-501 and 15-523

slide24

Applicable Policies and Procedures(cont’d)

UMB IRB Policies and Procedures

6c: Investigator and Study Personnel Conflicts of Interest http://medschool.umaryland.edu/orags/hrpo/HRPP_Policies.pdf

slide25

NIH Objectivity In Science

http://grants1.nih.gov/grants/compliance/42_CFR_50_subpart_F.htm

slide26

Reporting Requirements

  • Internal to UMB
    • As required in provisions
    • Annually
    • Whenever a significant change occurs
  • External to UMB
    • Chancellor
    • State Ethics Commission
    • Public Record
    • Research Sponsors, where applicable
slide27

Exemption Provisions/Conditions(examples)

Conflict of Commitment

Insider Trading

case study 1
Case Study #1
  • A clinical researcher receives $4,500 per patient from a pharmaceutical firm to enroll patients in a clinical trial of a new hypertension medication. The money covers patient care and administrative costs and includes a $200 finder’s fee. After the initial screening and enrollment, participants will make a total of eleven 15-minute office visits during the study. At each visit, nurses will take blood, record vital signs, and ask them questions about their hypertension. The clinical researcher will do a physical exam.
case study 2
Case Study #2
  • A clinical researcher has partial ownership of a patent on a new gene therapy technique. Her work is being funded by a biotech company, which owns the other part of the patent. She also has stock in the company. She plans to use her patented technique in clinical trials for gene therapy to treat breast cancer.
case study 3
Case Study #3

A junior scientist at a university discovered a new prostate cancer drug. With the help of the University’s Office of Research and Development, he applied for a patent and established an agreement that splits the profits between him and the university.

Using venture capital, the university formed a start-up company based on the technology. The scientist and his department chair were on the board of directors. Other board members included several university administrators and a few employees of the venture capital company. The patent was awarded a few years later. The company still has not realized any profit, but is very close to marketing the drug.

case study 3 cont d
Case Study #3 (cont’d)

The scientist, while at a conference, heard that a researcher at another university has come up with a drug very close in chemical structure to his, but one that is much more effective and has fewer side effects. Another group of venture capitalists has formed a company to manufacture the new drug as quickly as possible.

The junior scientist, with prodding from his original company, is now thinking about challenging the new company with a lawsuit on the basis of patent infringement.

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