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Setting up an Observatory of Data
Sharing and Clinical Trials : IMPACT (IMProving Access to Clinical Trial
data)
Karmela Krleža-Jerić Ottawa Group -IMPACT- Dpt of Research in Biomedicine and Health,
University of Split School of Medicine
IMPACT Observatory
IMProving Access to Clinical Trial data - IMPACT Observatory of ongoing transition in clinical research regarding data sharing; opportunities and barriers
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Karmela Krleža-Jerić
No conflict of interest
but
interest in research &
public disclosure of research data
KKJ
Open trial data
• Public health aspect; ultimate user and beneficiary aspects
• International aspect: dialogue, initiatives, actions, shift of paradigm, IMPACT
• Clinical trial aspect – transition regarding changes in data sharing
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5 Open Data
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Tim Berners-Lee, the inventor of the Web and Linked Data initiator, suggested a 5 star deployment
scheme for Open Data.
Available on web under open licence
Structured data (excel instead of
image scan of table)
Non-proprietary formats
(CSV instead of excel)
Use URI to denote things so
people can point on your stuff
Link your data
to other data to provide context
to
increase reliability of evidence for evidence informed decision making
Why do we want to open CT data?
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to
speed up knowledge creation and
development of better diagnostics and therapies
Why do we want to open CT data?
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Pooled analysis
data- knowledge-innovation pyramid
New therapies
Wisdom know how & what to do
Knowledge - evidence
Information - results
Data – findings
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IMPACT Observatory
IMPACT-IMProving Access to Clinical Trials data; Observatory of ongoing transition in clinical
research regarding data sharing, opportunities and barriers
KKJ
Observatory or natural experiment
• Experiment is not controlled by researcher
• No intervention by researcher
• Identifies changes/ transition
• Measures the impact of changes on…
• Points to barriers and facilitators of …
• Informs and thus indicates trends
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IMPACT Observatory story
• Ottawa Statement 2004 +
• WHO Trial registration standards 2006
• PROCTOR, Ottawa 2008 (CIHR-IRSC)
• Planning Meeting 2013-IMPACT Ottawa (British High Commission, University of Ottawa, participants)
• Environmental Scan Of Repositories Of Clinical Research Data: How Far Have We Got With Public Disclosure of Trial Data? COPE grant, 2012
• IMPACT(IMProving Access to Clinical Trials data); Observatory of ongoing transition in clinical research regarding data sharing; opportunities and barriers. NewFelPro Fellowship, 2014-
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IMPACT (2013)
(IMProve Access to Clinical Trial data)
• Explore definitions of raw data, meta-data
data formats, privacy
repositories, access to data for re-analysis and pooled analysis
• Develop methodologies, standards, guidelines
• Inform operationalisation, implementation
http://ottawagroup.ohri.ca/disclosure.html
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Public Disclosure of Results Standards (to be developed)
Protocol standards
(SPIRIT)
Trial registration
(WHO/international) standards
Publication reporting standards (CONSORT)
Better & more efficient trials
Setting up
• Host: Dpt for Research in Biomedicine and Health Uni of Split School of Medicine
• Team
Local
International
• Network
• Methodology
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IMPACT Observatory
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Methodology
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Public release of findings
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Barriers
How
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baseline
ongoing tendencies
Public sharing of findings
potential development in the future (trends)
Researc
hers
Regulators
Fu
nd
ers
Journals
Publishers
Pharmaceutical Industry Academia
Co
nsu
mer
Ad
vo
cate
s
Me
dia
Data Repositories
Policy
Culture
Infrastructure
Ac
ces
s
Preservation
Kn
ow
ho
w
IMPACT Observatory
Expected results
• identify tendencies of transitions, dynamics and roles of different players
• identify barriers, gaps and opportunities of opening clinical trial data
• indicate potential trends
• impact the transition
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Potential long term outcomes
IMPACT Observatory is established and continues as a longitudinal study with the aim to measure the
• Impact of interventions by many players on clinical trial research How it is done
How it is reported
How data are shared
How secondary analysis is done
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Who is IMPACT Observatory
• We are - anyone interested
• IMPACT Observatory team
• Everything we do depends on collaboration
• Multi nodal network
• Network of people/groups of people with good ideas: OG, PROCTOR, IMPACT, Cochrane, RDA
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