Conflict of Interest

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CI in Clinical Research

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Conflict of Interest:

Conflict of Interest By: Dr. Kopal Sharma Senior Demonstrator, Dept of Pharmacology SMS Medical College, Jaipur

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The clinical trial involved the injection of an adenoviral vector containing the gene. Jesse died after receiving the injection. Subsequent investigations found that the Principal Investigator was an inventor for the technology used in the trial and held equity in the start-up company to which the technology was licensed.

Conflict of Interest:

Conflict of Interest Definition - A conflict of interest ( CoI ) is a situation in which finanancial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.

Influences that pose distortion in objectivity:

Influences that pose distortion in objectivity A desire to validate a pet theory Overconfidence about a particular concept. Over-reliance on a belief held by a special group. Ruling out data that don’t support a hypothesis Internal or external pressures to get a specific results

CONFLICT OF INTEREST:

CONFLICT OF INTEREST Selection and retention of research participants. Reporting and attribution of adverse events Collection for data Statistical analysis, interpretation, and reporting of data.

Conflict of interest and clinical research:

Conflict of interest and clinical research Rewards and risks are both potentially great in clinical research. Eg . Tuskegee Study of syphilis (1932-72) and Willowbrook hepatitis study (1963-1966)

Slide 10:

Tuskegee Study Willowbrook hepatitis study

Types:

Types Financial/ Tangible Non-financial / Intangible

Financial:

Financial Receiving consulting fees from company while performing clinical research on the company’s technology. Owing stock in a company while performing research sponsored by the company. Involving students or post-doctoral students and trainees in work that could directly benefit a company in which the faculty member supervising the students has a personal financial interest.

Financial:

Financial Receiving licensing milestone payments for licensed technology while performing clinical research on that licensed drug. Sponsored or reimbursed travel for lectures. Consulting fees, honoraria, paid authorship.

Non Financial:

Non Financial Recruitment officer may have interest in influencing hiring procedures to secure a position for his brother or cousin, without direct financial benefit.

Non Financial:

Non Financial Conflict of commitment/Conflict of effort/ conflict of obligation. Occur when the extent of time spent on a secondary activity competes with the time expected to be spent on teaching, research, or service by the primary employer.

Researcher and CoI:

Researcher and CoI Researcher (Investigator) conducting the study - Publish in high impact factor journals – promotions - Money to travel to attend conference - Buy equipment - Hire people to assist - Upgrade office - Ghost writing etc.

Publisher and CoI:

Publisher and CoI Medical Journals - Have you seen journals disclosing how much money they get from pharma companies directly or indirectly? - Pharma companies sponsor doctors for buying books, journals and buy themselves large amount of reprints (profit margin is 70%)

Publication and CoI:

Publication and CoI Das KK et al. J Nepal Med Assoc. 2013 Apr-Jun; 52(190): 357-60 - Only 12% of the authors knew about CoI - Among the peer reviewers only 30% knew which 91.5% stated that they do not bother about this issue while reviewing the manuscripts. - Among the editorial board members of Indian medical journals only 25% have any idea on ‘conflict of interest’ issue.

EC and CoI:

EC and CoI As a member - Member is an investigator on research under review. - Holding significant financial interest in sponsor of research. - Loyalty to colleagues - Closely tied to area of research under review If familiar = too lenient If competitor = too critical

Slide 22:

S .NO. Topic General Policy 1. Adopt and implement conflict of interest policies 2. Strengthen disclosure policies 3. Standardize disclosure content and formats 4. Create a national program for reporting of company payments Medical Research 1. Restrict participation of researcher with conflicts of interest in research with human participants.

Slide 23:

S .NO. Topic Medical Education 1. Reform relationships with industry in medical education 2. Provide education on conflict of interest 3. Reform financial system for continuing medical education Medical Practice 1. Reform industry interactions with physicians

Slide 24:

S .NO. Topic Clinical practice guidelines 1. Restrict industry fundings and conflicts in clinical practice guideline development. 2. Create incentives for reducing conflicts in clinical practice guideline development Institutional conflicts of interest policies 1. Create board-level responsibilities for institutional conflicts of interest

Slide 25:

S .NO. Topic Supporting Organizations 1. Provide additional incentives for institutions to adopt and implement policies. 2. Develop research agenda on conflict of interest

Conclusion:

Conclusion Everyone has ‘ interests ’ but not all are often in conflict within ourselves and with others. We may not be able to eliminate all CoI , except maybe financial interest. - Not all conflicts are financials - Not all financial interests have conflicts If there is a CoI , disclose! Let the patient make the decision!

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