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

krlezajk@hotmail.com

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

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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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