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Ghislaine Poirier ILAR meeting, 3-4 June 2014 Increasing Animal Research Data Sharing: an Industry Perspective
Ghislaine Poirier ILAR meeting, 3-4 June 2014
Ghislaine Poirier
ILAR meeting, 3-4 June 2014

Increasing Animal Research Data Sharing: an Industry Perspective

Property of GlaxoSmithKline

Content

Content – Context – What is data? – Why data sharing? – Opportunities for data sharing

Context

What is data?

Why data sharing?

Opportunities for data sharing

Establishing an animal research data sharing strategy

Context

Context – 2011: Future of Animals in Research (FAIR) Project – 6-month project commissioned by head

2011: Future of Animals in Research (FAIR) Project

– 6-month project commissioned by head of R&D and run in the CEO’s office

– Strategy endorsed by the Company Executive & the R&D Executive teams

Leverage animal model data
Leverage
animal model
data
Bolster external collaborations
Bolster
external
collaborations

2012: Social Responsibility Commitment

Enhance scientific reviews
Enhance
scientific
reviews

Boost innovations in alternatives

– “to rigorously challenge the need for animal studies, and work to minimise the impact on animal welfare by investing in the development of alternatives and through sharing animal-based data

Walled Garden Project

Increasing Animal Model Data Sharing Internally and Externally
Increasing Animal Model Data Sharing Internally and Externally

Data, information and knowledge

Data, information and knowledge Re-use Design data study Archive report Write a report Animal Research Data

Re-use

Re-use Design

Design

data

study

information and knowledge Re-use Design data study Archive report Write a report Animal Research Data

Archive

report

knowledge Re-use Design data study Archive report Write a report Animal Research Data Lifecycle Ethical

Write a

report

Animal Research Data Lifecycle

Ethical

review

a report Animal Research Data Lifecycle Ethical review Conduct study Analyse results Capture results Data •

Conduct

study

Animal Research Data Lifecycle Ethical review Conduct study Analyse results Capture results Data • Results, facts,

Analyse

results

Data Lifecycle Ethical review Conduct study Analyse results Capture results Data • Results, facts, observations •

Capture

results

Data
Data

• Results, facts, observations

• Raw versus processed data

• Individual versus summary data

Information
Information

• Data presented in a context

Knowledge
Knowledge

• Information and how it is interpreted, i.e. opinions

Why sharing animal research data, information and knowledge?

Why sharing animal research data, information and knowledge? – For transparency – Increasing calls from the

For transparency

– Increasing calls from the public for greater transparency in animal research

To enable independent peer-review and cross-analysis

– Standards of care

– Methodological quality

– Variability and reproducibility

– Analysis of bias in the results

– Translational impact

To enable the development of new scientific hypotheses

To avoid un-necessary duplication of work

PUBLICATION BIAS

To avoid un-necessary duplication of work PUBLICATION BIAS   Whether to use an animal model
  Whether to use an animal model Whether to use an animal model 
 
Whether to use an animal model
Whether to use an animal model
 
Choosing an appropriate model
Choosing an appropriate model
 
Defining ways to use a model
Defining ways to use a model

EVIDENCE BASED DECISIONS

The old way of sharing scientific data: 1886

The old way of sharing scientific data: 1886
The old way of sharing scientific data: 1886
The old way of sharing scientific data: 1886

Current and emerging opportunities for sharing

Current and emerging opportunities for sharing – Traditional ways – Posters and oral presentations at scientific

Traditional ways

– Posters and oral presentations at scientific meetings

– Peer-reviewed scientific publications

– Electronic or on paper

– Open access or not

– Includes context and interpretation

Emerging opportunities

– Increasing trends towards collaborative partnerships

– Oral presentations at Webinars

– Contributions to On-line Networks

– DATABASES

– Peer-reviewed or not

– Formatted datasets

Developing an animal research data sharing strategy

Developing an animal research data sharing strategy • Which animal research ? What • What level
• Which animal research ? What • What level of information
• Which animal research ?
What
• What level of information
• Stage of the R&D process When • Retrospective vs prospective • How old will
• Stage of the R&D process
When
• Retrospective vs prospective
• How old will the data be?
With whom • Public or researchers?
With whom
• Public or researchers?
Where • Which type of repository?
Where
Which type of repository?

PURPOSE FOR SHARING

RISK MANAGEMENT

RESOURCES

BUDGET

How • Process
How
• Process
Approvals
Approvals

• Governance

Risk management

Risk management – Animal right activists – Could the information be misused? – Reputational risk –

Animal right activists

– Could the information be misused?

– Reputational risk

Insufficient context

– Could the data be misinterpreted?

– Reputational risk

Loss of competitiveness

– Valuable or competitive information being released

– Intellectual property risk

Inadvertent sharing of information the bound to third party agreement

– Legal risk

Information errors

– Could errors be introduced during the transfer of information to the repository?

– Data integrity risk

Understanding the R&D process context

Understanding the R&D process context CLINICAL DATA DISCLOSURE Target Lead Lead Pre-clinical Registration Phase I
CLINICAL DATA DISCLOSURE
CLINICAL DATA DISCLOSURE
Target Lead Lead Pre-clinical Registration Phase I Phase II Phase III Phase IV Validation Discovery
Target
Lead
Lead
Pre-clinical
Registration
Phase I
Phase II
Phase III
Phase IV
Validation
Discovery
Optimisation
Evaluation
& Launch
ANIMAL RESEARCH
ANIMAL RESEARCH

Managing stakeholders: getting buy-in

Managing stakeholders: getting buy-in – Stakeholder management plan – Stakeholder map – Internal –

Stakeholder management plan

– Stakeholder map

Internal

External: private companies, other research institutions

– How important they are ?

– How will they be impacted?

– How will they benefit?

– Are they critical subject matter experts?

– Are they decision makers?

Managing the cultural change

– CRITICAL

– Understanding habits and concerns

– Teasing apart the emotional side from the rational side

Communication plan

Benefits of sharing animal research information

(2012 survey, 53 internal stakeholders)

research information (2012 survey, 53 internal stakeholders) If data could be shared externally, what scientific
If data could be shared externally, what scientific questions would you address by interrogating the
If data could be shared externally, what scientific questions would you address
by interrogating the data?

Selection of most appropriate model

Information of model validation: Determine whether models provide data that can be translated to the clinic

Understand sources of experimental variations (e.g. seasonal changes)

• Find information on factors that affect optimal study design (e.g. animal age)

Optimize design/power calculations & reduce inter-lab variation

Search for 3Rs advances

• Investigate & validate new biomarkers

• Prediction & control of side effects in certain models

• Has data from a particular model been replicated in another lab?

• Responses to gold standard drugs could be compared

• Compare results of using different dose routes

Quality of information: impact on reproducibility

Quality of information: impact on reproducibility Animal characteristics Macro- Environment F o o d / w
Animal characteristics
Animal
characteristics
Macro- Environment
Macro-
Environment

Food/water

Age

Temp

Water purification

Light

Humidity

Noise

Routines
Routines
cage- Environment
cage-
Environment
Microbiological status
Microbiological
status

Acclimatization

Group size

Pathogens

Cage changes

Bedding

Commensals

Enrichment

Quality of information: Impact the efficiency and effectiveness of re-use

Impact the efficiency and effectiveness of re-use – Context – International documentation guidelines :

Context

International documentation guidelines : ILAR, ARRIVE, GSPC, Disease-specific guidelines

Implementation needs time and resources

Format

Electronic lab notebooks

datasets in pdf format cannot be re-used easily

Standards

Standards in Safety Toxicity: GLP practices, SEND

Few standards in efficacy pharmacology

easily – Standards – Standards in Safety Toxicity: GLP practices, SEND – Few standards in efficacy

Conclusion

Conclusion – Data sharing has reputational, scientific and animal benefits – There is increasing trends towards

Data sharing has reputational, scientific and animal benefits

There is increasing trends towards data sharing, and culture change is happening, but change management remains critical

Risk management needs to be carefully addressed

Establishing a data sharing strategy is a team exercise that requires multiple expertise, time and resources