The formation of the ANZMUSC Clinical Trials Network and ... › wp-content › ... · meetings at...
Transcript of The formation of the ANZMUSC Clinical Trials Network and ... › wp-content › ... · meetings at...
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The formation of the ANZMUSC
Clinical Trials Network and lessons learned
Rachelle Buchbinder
NHMRC Senior Principal Research FellowDirector, Monash Dept Clinical Epidemiology, Cabrini Institute
Professor, Dept Epidemiology & Preventive Medicine, Monash University
ACTA Nov 2018
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Disclosure
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How did we get here?
• Noted success of Australian networks, first ACTA summit 2014
• Serious plan started five years ago with a couple of informal
meetings at the Australian Rheumatology Association ASM
• Scoping study funded by Arthritis Victoria (now MSK Australia)
• Formation of a steering committee, planning for national summit,
website, logo
• Web-based survey - elicit interest and potential perceived benefits
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Burden of musculoskeletal disorders
• 6.8% of total global burden of disease (both death and disability)
• 18.3% of years lived with disability
• Affects 28% (>6.1 million) Australians
• Second greatest impact after cancer
Murray CJ, Vos T, et al. Lancet 2014, 2015; AIHW 2016
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TOP FIVE
1 - Low back pain2 - Major depressive disorder3 - Other musculoskeletal 4 - Neck pain5 - Falls
11 - Osteoarthritis
Years Lived with Disability (YLDs) in Australia
http://www.healthdata.org/results/country-profiles
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Mismatch between burden and research funding
• Worldwide, MSK conditions receive relatively less research focus compared to other less costly, less burdensome health conditions
Buchbinder R, Maher C, Harris I. Setting the research agenda for improving health care for musculoskeletal disorders. Nat Rev Rheumatol 2015; 1: 597-605.
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Evaluation of NHMRC funding 2010 to 2014
Annual investment
• Arthritis ~$25m vs $110m cardiovascular, $70m diabetes ~$70 mental health
Number of submitted vs successful grants in 2014
• Arthritis 159 submitted, 16% successful
• Cardiovascular 730 submitted, 18% successful
• Diabetes 409 submitted, 19% successful
• Mental health 504 submitted, 16% successful
In Australia and globally just as successful but reduced research capacity relative to other fields
https://nhmrc.gov.au/about-us/publications/nhmrc-research-funding-facts-book-2014
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Bourne A, Whittle S, Richards B, Maher C, Buchbinder R. MJA 2014; 200;88-91.
• 29 NHMRC funded MSK RCTs 2009-13; ~ 5.8 per year
• 128 Australian-initiated registered trials 2011-12 (many small,
may not be asking most important questions)
• ~1 in 20 (30/565) Australian investigator-initiated RCTs
published in 37 leading journals 2011-12
• None were implementation trials
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Number ($) of MSK clinical trials funded by NHMRC
Project grants, 2009-2013
3,631 grants($2,076,132,819)
~1%
29 grants for MSK trials($17,612,303)
Bourne A, et al MJA, 2014
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ANZMUSC Steering Committee
Sam Whittle ADELAIDE
Chris MaherIan HarrisJane LatimerBethan RichardsSYDNEY
Rachelle BuchbinderOrnella Clavisi (consumer)MELBOURNE
William TaylorNEW ZEALAND
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Inaugural summit April 2015, Melbourne
• Funded by professional societies, consumer organisations,
Monash/Sydney Uni, Cabrini/George
• Invited trialists from scoping review list (100 participants)
• 2 facilitators (Profs John Zalcberg, Alan Silman)
• Why we need an MSK clinical trial network
• Day 1: hesitation, distrust, concerns
• By the end of Day 2: agreed vision, mission, values, one year goals
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The ANZMUSC Vision
To optimise musculoskeletal health through high
quality, collaborative clinical research
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Mission
• To identify the key clinical research questions relevant to MSK health
• To improve the scientific quality of MSK research and its translation
into policy and practice
• To facilitate and endorse clinical research based on scientific quality
and potential to improve health outcomes
• Advocate for MSK research support
• Foster collaboration between research groups and stakeholders
• Advance the understanding of research through mentoring and
education
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Why do we need a MSK clinical trials network?
• Current funding suboptimal and starkly disproportionate
with the MSK global burden
• Current trials small and may not be focused upon the most
important clinical questions
• >30 Australian collaborative clinical trial groups but none for
musculoskeletal conditions
• Trial networks highly successful
• Collaborative network only viable and sustainable model
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Web survey
• 112 musculoskeletal trialists (invited 243, response rate 46%)
• All states and territories (except NT), 15% NZ
• 20 different disciplines
• 66% (74/112) interested in belonging to a network, 25% (28/112) undecided
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Potential benefits of network membership
Six themes
1. Collaboration/networking
2. Funding
3. Learning/gaining experience/peer review
4. Priority-setting
5. Advocacy for musculoskeletal disease/research
6. Avoidance of duplication
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External Advisory Group Prof John Zalcberg (Chair)Prof Martin UnderwoodProf Sallie LambProf Andrew CarrDr Sue PhillipsA/Prof Per Olav Vandvik Ms Ainslie Cahill
Executive Committee (EC)Prof Rachelle Buchbinder (Chair)Prof Chris Maher (Deputy Chair)Prof Ian Harris AM (SAC Chair)Prof Jane LatimerA/Prof Will TaylorDr Sam WhittleDr Bethan RichardsProf Rana HinmanMs Ornella Clavisi (CAG Chair)
Scientific Advisory Committee (SAC)Prof Ian Harris AM (Chair) (NSW)Dr Dawn Aitken (TAS)Prof Catherine Hill (SA)Dr Steve Kamper (NSW)Dr James McAuley (NSW)Prof Lisa Stamp (NZ)Dr Donna Urquhart (VIC)A/Prof Bruce Walker (WA)Prof Tania Winzenberg (TAS)
Consumer Advisory Group (CAG)Ornella Clavisi (Chair)Linda Spurrier (ACT)Annie McPherson (VIC)John Ure (NSW)Suzie May (WA)Jackie Gibson (VIC)Danielle Dunlevey (SA)Sally Carkeet (QLD)Charlotte Hewson (NZ)
Administrative OfficeExecutive Officer (Allison Bourne)
ANZMUSC MembersFull members: Individual trialistsAssociate Members: Non-trialists, professional associations, consumer organisations, insurance groups, policy makers, consumers
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ANZMUSC Endorsement Process
Meeting presentation
Scientific review
Decision
Trial
Review of trial protocols prior to ASM (SAC, CAG)Presentation and feedback at ASMMembership comments
Formal review of trial protocols (SAC, CAG)Recommendation to Endorse, Develop or RejectResubmission after addressing review comments
Executive Committee
ANZMUSC authorship policyRegular reportingManagement support, audit to ensure quality
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NHMRC Centre for Research Excellence, 2018-2022
Chief InvestigatorsRachelle BuchbinderChris Maher Lyn March Richard Day Rana Hinman Ian Harris Manuela Ferreira Paul GlasziouSally Green Laurent Billot
Associate InvestigatorsAnthony Harris Catherine Hill Chung-Wei Christine Lin David HunterFlavia Cicuttini James McAuley Jane LatimerSamuel Whittle Tania Winzenberg William Taylor
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Overarching model underpinning ANZMUSC
Buchbinder R, Maher C, Harris I. Setting the research agenda for improving health care for musculoskeletal disorders. Nat Rev Rheumatol 2015; 1: 597-605.
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Development of a multi-attribute tool for setting
priorities for trials in the musculoskeletal field
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Typical approach to research prioritisation
Directly identify the research topics
Stakeholder engagement
Generate lists of research questions or topics and review research gaps
Identify the ‘top ten’ research topics
Choices usually implicit
• No understanding of why priorities were ranked in the order that they were
• Participant bias • Need to repeat the process when new
topics arise
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Another approach
Directly identify the research topics
Identify the underlying basis for research question value
Stakeholder engagement
Generate lists of research questions or topics and review research gaps
Identify the criteria on which to base a judgement of research importance
Multi-attribute criteria approach
Identify the ‘top ten’ research topics
Choices made explicit
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Develop living systematic reviews and guidelines
• ANZMUSC Practitioner Fellow: Dr Sam Whittle appointed July 2018• Cochrane Living Systematic Reviews and Therapeutic Guidelines PL
• Stem cell therapy for osteoarthritis of the knee• Arthroscopic surgery for degenerative knee disease (osteoarthritis including
degenerative meniscal tears)
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Training, capacity building, mentoring
• PhDs, postdocs, practitioner fellowships
• Seeding grants open to all ANZMUSC members
– 4 awarded this year
• Advice, protocol development, auditing, governance assistance
• PhD scholarships including 2 externally funded
– COCA, Medibank Private
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Progress over 5 years• >230 members, >30 disciplines, consumers actively involved
• 4 annual national 2-day summits (2016 Sydney, 2017 Adelaide, 2015, 18 Melbourne),
half-yearly update meetings
• NHMRC Centre for Research Excellence, 2018-2022, launched by Hon Greg Hunt
• 6 ANZMUSC endorsed trials
• 3 NHMRC-funded ANZMUSC-endorsed trials (1 funded in 2017, 2 in 2018)
• 1st NHMRC-MRFF funded trial
• 1st ANZMUSC-endorsed trial protocol published
• Early development of ANZMUSC paper, submitted for publication
• Scoping review of musculoskeletal trial priority-setting projects, in press BMJ Open
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What have we learned?
• Start slowly and bring stakeholders with you – need time to build trust
• Involve stakeholders including consumers from the outset
• Professional societies supportive
• ACTA and other networks hugely helpful
• Multidisciplinary, multiple settings so not under a single organisation
• Be transparent and open
• Communicate frequently
• Many hands makes light work
• No harm in asking
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Acknowledgements
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Values
• Visionary
• Altruistic (generous, benevolent)
• Scientific integrity
• Transparency
• Equity
• Mutual respect
• Health consumer centred
• Ethical
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Member disciplines
Chiropractor
Clinical Epidemiologist
Rheumatologist
Non-clinical researcher
Clinician, otherNurse
Physiotherapist
Exercise Physiologist
Consumers
Policy makers/funders
Pharmacist
Professional/Consumer Organisation
5.6 %
5.6 %5.1 %
14.1 %
11.9 %
15.3 %
3.4 %
25.4 %
4 %
3.4 %
2.8 %
3.4 %