Conflict of Interest. Sudhakar Bangera MBBS, MD, MMedSc Program Director, CDSA.

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1 Conflict of Interest Sudhakar Bangera MBBS, MD, MMedSc Program Director, CDSA

2 Disclaimer This presentation reflects the views of the author and should not be construed to represent Government of India s views or policies

3 Conflict of Interest Definition A conflict of interest (CoI) is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity Use of a person's authority for personal and/or financial gain

4 Conflict of Interest CoI may involve individuals (investigator, monitor, members of Governance Committees, regulators and others) and institutions/ organisations CoI may imply the potential for bias, and may not be a likelihood CoI misconduct (fabrication, falsification, and plagiarism)

5 Conflict of Interest Not only can a conflict lead to injury or harm to particular study participants but, on a larger scale, a CoI can damage an entire research enterprise by reducing the trust and confidence that people generally have in research

6 Conflict of Interest In an effort to succeed, there are myriad areas where bias can influence judgment and diminish 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 result are all influences that may lead to distortions in objectivity

7 Conflict of Interest Selection and retention of research participants Reporting and attribution of adverse events Collection for data Statistical analysis, interpretation, and reporting of the data

8 Conflict of Interest Bias can be too subtle to recognize and too difficult to control Your mind-set may cause you to overlook important data or to misperceive critical observations

9 CoI and Clinical Research Rewards and risks are both potentially great in Clinical Research Examples: Tuskegee Study of Syphilis ( ) and the Willowbrook Hepatitis Studies ( )

10 Conflict of Interest Types Financial/ tangible Non-financial/ intangible

11 Types of Conflicts Financial Receiving consulting fees from a company while performing clinical research on the company s technology Owning stock including immediate family members, 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

12 Types of Conflicts 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

13 Types of Conflict Non-Financial Recruitment officer may have an interest in influencing hiring procedures to secure a position for his brother or cousin, without direct financial benefit Conflicts of commitment/ Conflicts of effort/ conflicts 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. Most universities in the USA have policies allowing 20% of a faculty member's effort, or one day a week, for outside activity

14 My Percep)on on Conflict of Interest

15 Industry and CoI Pharmaceutical Companies To recoup the R&D expenditure, for expansion, improvise their bottom-line and retain their jobs Spend approximately $12 15 billion annually on gifts and payments to physicians in the USA influencing the physicians' prescribing choices Distributing pens and pads to office staff, to gifts of tickets to sporting and theater events, to all-expense paid trips to drug-company sponsored seminars at resort hotels, stethoscopes, spa, paying the costs for spouses to attend any meeting or function

16 Industry and CoI Pharmaceutical Companies Hiring a healthcare professional under the guise of a "consultant" or "advisor," or focus group participant or advisory board member, or even as a speaker at a meeting, could be considered "payments for referrals. However, where the professional is compensated for actual, reasonable and necessary services, the activities may be considered legitimate CROs Happy to get business, grow and there is no need to put back the money in science or new treatment unless there is financial sharing

17 Agencies and CoI Regulatory Agency CDSCO, ICMR, DBT, Ministry of Environment & Forests (GEAC) Consultants NDAC/ SEC TRC Apex Committee

18 Researcher and CoI Researcher (Investigator) conducting the study Publish in high impact factor journals à Promotions Money to travel to attend conference Buy/ donation of equipment Hire people to assist Upgrade office Part of committees Ghost writing, etc.

19 Cuts Sink tests Kickbacks 40 to 60% for lab tests 30 to 40% for referring to consultants, specialists & surgeons 30 to 40% of total hospital charges Admitting the patient to "keep him under observation Caesarean surgeries and hysterectomies "Emergency surgery" on dead body To a man with a hammer, every problem looks like a nail. Surgeons like to solve medical problems by cutting, just as physicians first seek solutions with drugs The young docs who paid a huge fee or set up a nursing home, etc. have heavy loans to settle

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

21 Publication and CoI Das KK et al. J Nepal Med Assoc Apr- Jun;52(190): Questionnaire and telephone interview regarding their understanding and knowledge on 'conflict of interest' Total 61 authors who have published research articles recently in Indian medical journals from peer reviewers who reviewed the manuscripts during same period 35 editorial board members of various Indian medical journals were assessed

22 Publication and CoI Das KK et al. J Nepal Med Assoc Apr-Jun; 52(190): Only 12% of the authors knew about CoI Among the peer reviewers only 30% knew of which 91.5% stated that they do not bother about this issue while reviewing the manuscripts 75% of the peer reviewers confessed that they had a bias on the topics written by their friends or students. Among the editorial board members of Indian medical journals only 25% have any idea on 'conflict of interest issue

23 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

24 EC and CoI Institutional Level Concern for institution s reputation or prestige Promoting research vs. protecting subjects Potential liability (and hence no research at all) Institutional or community values Pressure for speedy reviews Institutional equity or ownership Review fees

25 Managing CoI at EC Level Financial Disclosure Form Set up a limit for having direct financial interests in the study sponsoring company Immediate family s financial and non-financial interest Have more non-scientific and non-institutional members (counter balances internal and institutional pressures!!) EC to maintain sufficient independency (keeping management out; prohibit equity owners from participating in the EC review process)

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27 Managing CoI at EC Level ECs should have access to sufficient resources (office, computers, archival and fund) to adequately carry out their duties (not depend financially on institution Government funds for administration? Periodic review by Regulators

28 Conclusion Clinical trials are necessary to find out what is safe and what works so that health professionals know how to prevent and treat illness effectively Human research participants are a means to developing knowledge that will benefit others Although participants may be among the beneficiaries of research knowledge, they do not necessarily benefit directly from participation in research

29 Conclusion Everyone has interests (ELSI) but not all are often in conflict within ourselves and with others What are the interests in the context of research. Could the financial interest affect the research, or is it in an entity whose financial interest could be affected (gained or lost) by the research? You may not be able to eliminate all CoI, except maybe financial interests Not all conflicts are financials Not all financial interests have conflicts If there is a CoI, disclose! Let the patient make the decision! My Gain, Your Ruin!

30 Documents to Consider WMA Statement on Conflict of Interest. Adopted by the 60 th WMA General Assembly, New Delhi, India, October

31 Thank You