Avoiding waste in research:the role of public involvement
Iain ChalmersCoordinator, James Lind Initiative
‘Putting people first in research’INVOLVE Conference
Nottingham, 13 November 2012
The skeletons in academic medicine’s cupboards
Low priority questions addressed
Important outcomes not assessed
Clinicians and patients not involved in setting research agendas
Questions relevantto clinicians &
patients?
Over 50% studies designed without reference to systematic reviews of existing evidence
Over 50% of studies fail to take adequate steps to reduce biases, e.g. unconcealed treatment allocation
Appropriate design and methods?
Over 50% of studies never published in full
Biased under-reporting of studies with disappointing results
Accessible full publication?
Over 30% of trial interventions not sufficiently described
Over 50% of planned study outcomes not reported
Most new research not interpreted in the context of systematic assessment of other relevant evidence
Unbiased and usable report?
50%
85% Research waste = over $85 Billion / year
50%
50%
Mismatch of patients’ and researchers’ priorities for osteoarthritis of the knee
Tallon, Chard and Dieppe. Lancet, 2000.
Priority treatment outcome from a survey of patients with rheumatoid arthritis was not pain
It was fatigue
For every ongoing trial being conducted within the NHS, the UK Clinical Trials Gateway should aim to provide access to: a lay summary the patient information sheet the WHO 20-item dataset the protocol, with links to the systematic review(s) showing why the trial is needed the trial website (if one exists)
Reliable, user-friendly information about specific ongoing clinical trials is
still NOT generally available
2003-The James Lind Initiative
Funded by the National Institute of Health Research and the Medical Research Council
“to promote acknowledgement of uncertainties about the effects of treatments, and
research to address them.”
Programme of work of The James Lind Initiative
1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance
3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
The UK Database of Uncertainties about the Effects of Treatments
Established to publish uncertainties about the effects of treatments which cannot currently be answered by referring to relevant and reliable, up-to-date systematic reviews of existing
research evidence
UK DUETs draws on three main sources
•Patients', carers' and clinicians' unanswered
questions about the effects of treatments
•Research recommendations in reports of
systematic reviews and clinical guidelines
•Ongoing research, both systematic reviews in
preparation and new 'primary' studies
Programme of work of The James Lind Initiative
1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance
3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
To increase the focus of the therapeutic research agenda on questions and priorities shared by patients and clinicians.
To promote Priority Setting Partnerships involving patients and clinicians to identify and promote their shared priorities for therapeutic research.
To increase general awareness and understanding of the need to refocus the therapeutic research agenda.
Sally CroweChair, JLA Monitoring & Implementation Group
Lester FirkinsChair, JLA Strategy
& Development Group
Patricia AtkinsonAdministrator,JLA Secretariat
Katherine CowanEditor, JLA Guidebook
Involving patients, carers and clinicians in research priority setting
The JLA’s principles•Inclusive
•Balance of perspectives•Accessible to all
•Supportive•Recognising a range of capacities and skills
•Transparent and democratic•Data sharing•Agreed protocol•Declaration of interests•Neutral facilitation •Communication and feedback
JLA Priority Setting Partnerships
Completed Current •Asthma•Urinary incontinence•Vitiligo•Prostate cancer•Schizophrenia•Type 1 diabetes•ENT aspects of balance•Life after stroke•Eczema•Tinnitus•Cleft lip and palate
•Acne•Childhood disability •Dementia•Dialysis•Head and neck cancer•Inflammatory bowel disease•Lyme disease•Multiple sclerosis •Pressure ulcers•Pre-term birth•Sight loss and vision
Research priority themes [across asthma,
incontinence, vitiligo, eczema, stroke, prostate cancer, schizophrenia, aspects of balance, and type 1 diabetes]
• Assessment of long-term effects (wanted and unwanted) of treatments
• Assessment of safety and adverse effects of treatments
• Assessment of complementary and non-prescribed treatments
• Assessment of strategies to improve early diagnosis and treatments, and harmonisation of practice
• Assessment of the effectiveness and safety of self-care
Low priority questions addressed
Important outcomes not assessed
Clinicians and patients not involved in setting research agendas
Questions relevantto clinicians &
patients?
Over 50% studies designed without reference to systematic reviews of existing evidence
Over 50% of studies fail to take adequate steps to reduce biases, e.g. unconcealed treatment allocation
Appropriate design and methods?
Over 50% of studies never published in full
Biased under-reporting of studies with disappointing results
Accessible full publication?
Over 30% of trial interventions not sufficiently described
Over 50% of planned study outcomes not reported
Most new research not interpreted in the context of systematic assessment of other relevant evidence
Unbiased and usable report?
50%
85% Research waste = over $85 Billion / year
50%
50%
Publication (2007) after registration (1999)
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM (2009). Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6(9): e1000144.
Country
Size
Phase
Funder
“Studies that report positive or significant resultsare more likely to be published and outcomes that are statistically significant have higher oddsof being fully reported.”
PLoS ONE, August 2008;3:e3081
Alessandro Liberati
Because research results have not been made public…
…patients have suffered and died unnecessarily and resources for health care and health research have been wasted.
TGN1412
TGN 1412
What is the position of the Academy of Medical Sciences?
2006 letter to Prof John Bell, President, Academy of Medical Sciences
What should be done?
The public needs to be made aware of how the resources they provide for research are being wasted.
The public needs to hold the research community to account, and be critically involved in research, from agenda setting to dissemination of results.
Programme of work of The James Lind Initiative
1. Identifying and publishing uncertainties about the effects of treatments: UK Database of Uncertainties about the Effects of Treatments
2. Identifying patients’ and clinicians’ shared priorities for research about the effects of treatments: James Lind Alliance
3. Explaining and illustrating the development of fair tests of treatments in health care: James Lind Library and Testing Treatments
www.jameslindlibrary.org
…but only if it meets scientific and ethical principles
Promote research on the effects of treatments…
www.testingtreatments.org
“Bad Science introduces the basic scientific principles to help everyone become a more effective bullshit
detector.”
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