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Trust and transparency

Trust and transparency. Dr David Tovey FRCGP Editor in Chief, The Cochrane Library. Agenda. Trust and transparency in medical research and guidelines (& Cochrane) Threats Solutions. Trust and transparency in medicine. Building blocks of trust: Competence Compassion Realism

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Trust and transparency

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  1. Trust and transparency Dr David Tovey FRCGPEditor in Chief, The Cochrane Library

  2. Agenda • Trust and transparency in medical research and guidelines (& Cochrane) • Threats • Solutions

  3. Trust and transparency in medicine • Building blocks of trust: • Competence • Compassion • Realism • Sharing power • Personal care (Fugelli P)

  4. Trust and transparency in research • Why do patients enrol in a clinical trial? • To benefit from new agents • To assist and support research • To improve health care in the future • Not something to take lightly

  5. Trust and transparency and Cochrane • Transparency at the heart of EBM • Primary function to conduct high quality systematic reviews.. Hill S, Kaufman J, Dilkes H 2011

  6. Threats: Conflict of Interest • What is it? • Circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest (Bero, L) • A risk—not necessarily the existence of biased judgment or action

  7. Does it matter? “Even the most enthusiastic Manchester United fan wouldn’t think it right for Sir Alex Ferguson to referee the match” (Godlee, F)

  8. Cochrane Collaboration COI policy • “Sponsorship of a Cochrane review by any commercial source or sources is prohibited.” • All review authors complete COI form pre-publication • Allows: • Financial ties of authors (disclose) • Industry employees as authors (minority of authors within team)

  9. Conflicts of interest • Physician rewards programmes • “Hospitality” and CME • Enrolment into research • Sponsorship of clinical trials • Participation in conduct and reporting of research • Involvement in evidence synthesis and guidelines programmes

  10. Conflict of interest in research • "There is a serious problem of trust and trustworthiness in at least some industry-sponsored research. It is unjustly exploitative of human subjects to allow them to imagine that they are contributing to the advance of science if in fact the design of the study has been manipulated specifically to obtain data that the company will use to it's marketing advantage rather than answer any scientific question of real interest or importance." Howard Brody

  11. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute

  12. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute

  13. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute Guidelines on treating elevated cholesterol levels

  14. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute Guidelines on treating elevated cholesterol levels lower the threshold for treating patients with statins and increase the dosages

  15. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute Undisclosed links to manufacturers Guidelines on treating elevated cholesterol levels lower the threshold for treating patients with statins and increase the dosages

  16. Conflict of interest in guidelines July 2004: expert panel convened by the National Cholesterol Education Project of the NIH's National Heart, Lung and Blood Institute Undisclosed links to manufacturers Guidelines on treating elevated cholesterol levels Reduced trust and credibility lower the threshold for treating patients with statins and increase the dosages

  17. Financial ties of guideline committee members • Cross-sectional survey of 192 authors of 44 guidelines endorsed by NA and European societies (52% response) • 59% had financial relationships with companies whose drugs were considered in the guideline (almost all pre-dating) • 95% not declared in published CPG • Choudhry et al, JAMA 2002

  18. There is a real dilemma though..... • “The only person who doesn’t have a vested interest in a subject is somebody who knows nothing about it” (Richard Smith ex Editor BMJ)

  19. Threats • Reporting bias • Publication Bias • Outcome selection bias

  20. Trust and transparency in research

  21. Trust and transparency in research

  22. Trust and transparency in research

  23. Trust and transparency in research

  24. Trust and transparency in research • Results: • 102 trials, 3736 outcomes • 50% efficacy and 65% harms outcomes / trial incompletely reported • Statistically significant outcomes more likely to be correctly reported than non significant outcomes

  25. Trust and transparency in research • “Journals have devolved into information laundering operations for the pharmaceutical industry” (Richard Horton, Editor, The Lancet) • “Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies” (Richard Smith, Ex-Editor, BMJ)

  26. What can be done: some solutions

  27. Trust and transparency in research http://www.jameslindlibrary.org/testing-treatments.html

  28. Trust and transparency in research http://www.jameslindlibrary.org/testing-treatments.html

  29. Trust and transparency in research “in the publication of research results, the investigators are obliged to ensure the accuracy of the results. Negative as well as positive results should be published or otherwise made publicly available..” Idanpaan-Heikkila J E, Fluss S

  30. What can be done? Cochrane statement: • “All randomised clinical trials to be registered at their inception, before recruitment of the first participant • All data from all randomised clinical trials and the corresponding trial protocols to become publicly available free of charge and in easily accessible electronic formats • Need to hold and make available core data indefinitely

  31. What can be done? Cochrane statement: • “All randomised clinical trials to be registered at their inception, before recruitment of the first participant • All data from all randomised clinical trials and the corresponding trial protocols to become publicly available free of charge and in easily accessible electronic formats • Need to hold and make available core data indefinitely

  32. What can be done? Cochrane statement: • “All randomised clinical trials to be registered at their inception, before recruitment of the first participant • All data from all randomised clinical trials and the corresponding trial protocols to become publicly available free of charge and in easily accessible electronic formats • Need to hold and make available core data indefinitely

  33. What can be done? Continued: • Governments to consider punitive measures for non-compliance • Governments to consider introducing legislation requiring data from all trials to be made public within 12 months from the end of the randomised phase of the trial • Recognition that ownership of trial data should be shared between sponsors, investigators and trial participants”

  34. What can be done? Continued: • Governments to consider punitive measures for non-compliance • Governments to consider introducing legislation requiring data from all trials to be made public within 12 months from the end of the randomised phase of the trial • Recognition that ownership of trial data should be shared between sponsors, investigators and trial participants”

  35. What can be done? Continued: • Governments to consider punitive measures for non-compliance • Governments to consider introducing legislation requiring data from all trials to be made public within 12 months from the end of the randomised phase of the trial • Recognition that ownership of trial data should be shared between sponsors, investigators and trial participants”

  36. What about guidelines?

  37. Guidelines: the way forward • WHO and IOM setting high standards • Disclosure necessary but not sufficient • Importance of transparency: guidelines agency and panel members • Role of chair-person • Exclusion (partial or complete) of conflicted members • Broad view of COI

  38. Summary • Trust and transparency lie at the heart of medicine • Needs to apply at all levels: • Clinical practice • Research • Guidelines • Policy making

  39. Thanks for listening dtovey@cochrane.org

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