TRUST AND TRANSPARENCYDr David Tovey FRCGPEditor 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 Sharing power Personal care

(Fugelli P)

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

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

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

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)

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)

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

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

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

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

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

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

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

Undisclosed links to manufacturers

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

Undisclosed links to manufacturers

Reduced trust and credibility

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

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)

Threats

Reporting bias Publication Bias Outcome selection bias

Trust and transparency in research

Trust and transparency in research

Trust and transparency in research

Trust and transparency in research

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

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)

What can be done: some solutions

Trust and transparency in research

http://www.jameslindlibrary.org/testing-treatments.html

Trust and transparency in research

http://www.jameslindlibrary.org/testing-treatments.html

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

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

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

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

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”

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”

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”

What about guidelines?

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

Summary

Trust and transparency lie at the heart of medicine

Needs to apply at all levels: Clinical practice Research Guidelines Policy making

Thanks for listening

dtovey@cochrane.org