different interoperability needs for clinical research

New needs for interoperability in Clinical

Research

New needs for interoperability in Clinical

ResearchMats Sundgren

Global Clinical Development AstraZeneca

What this lecture is all aboutWhat this lecture is all about

”Discuss aspects of interoperability needs to realise added value of health information - linking patient care, clinical researchand public health”

New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 2

OutlineOutline

• Global trends in science & medicine• The changing face of pharma industry• Drivers & interoperability needs for the pharma

industry in the next years• In context – health data and the case of Innovative Medicine

Initiative (IMI) and the EHR re-use project

• Conclusions


• The need to improve on available therapy• Tailored for the individual• Very early diagnosis• Modification of disease

• Ageing – diseases and symptoms• “Old” and new infections• Sedentary life style – in all ages,

throughout the world• Improved health care generates new

demands

The changing face of unmet medical need

Pharma Industry TrendsPharma Industry Trends

• Much more complex • From “Art to Science”• Multidisciplinary• Parallel work at risk• Superior properties required• Safety concerns greater

• Regulatory requirements• Safety & efficacy• Much larger programs• Hard end-points (outcome

studies)• Value demonstration

Source: CMR International & IMS Health

0

50

100

150

200

250

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007*

Inde

xed

to 1

997

R&D spend Dev. times NMEs Sales

R&D spend

NME

A challenge for pharma

A concern for society

Drivers for Life Science InnovationDrivers for Life Science Innovation

• Advances in computer science• Shift in scientific method (Systems biology)• Information & Communication Technologies

(ICT)• Explosion in information & data availability• New tools for understanding biology &

medicine• Redefining Knowledge Management • New collaboration models for bridging

connections for innovation

The changing face of pharma industryThe changing face of pharma industry

• Moving from traditional R&D model towards a collaborative model• Externalization, Transparency, Public – Private – Partnerships

• Were knowledge management and information interoperability are key capabilities

New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 7New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

Why is information interoperability important?Why is information interoperability important?

• The use of health information generated in the external environment (e.g. EHR) will become central to new drug development business model:

Traditional pharma R&D: creation, control and dissemination of information

Huge increase in information from the patient population; accessible by many parties


ChallengesChallenges

• The challenge for the industry is no longer how to capture and manage data in clinical trials. • But to exploit all the information that is available without running

clinical trials: legacy data from our clinical research, external research databases, biomedical literature and, not the least, electronic health records.

• Build capabilities through collaboration to address interoperability needs (semantic, organisational etc) to connect health data with clinical research • is a multi facet, multi stakeholders undertaking with regulatory,

organizational and technical components. These components are inter-related; all of them are needed

• Impact on both new drug development and health care and patients

that is available without running


New Information Landscape For the Pharmaceutical Industry


New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca

10

The Internal Information Domain - AZThe Internal Information Domain - AZ

• Company generated scientific information in new drug development such as:• Clincal Study data – on going projects• Clincal Legacy data (terminated projects)• Textual information (e.g. reports, protocol)• Pre-clinical information and data, etc.

• High need of make optimal re-use of information, • Increased demand to share information

externally• Pace of Information production and supporting

technology: high speed


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http://www.biomonitor.dk/wp-content/uploads/clinical-data.gif

The External Regulated Information DomainThe External Regulated Information Domain

• Access controlled information sources such as:• Academic data bases• Health care (EHR, PHR)• Scientific data bases• National Disease Registers• Scientific Journals • Real World Data.....

• Represent “validated” scientific information with very high relevance for clinical research

• Pace of Information production and supporting technology: high speed


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The External Open Information DomainThe External Open Information Domain

• Free access information sources such as:• Open accessible data bases • Patient communities• Blogs• Conferences

• Represent a mix of “validated” scientific information with potential high relevance for clinical research

• Pace of Information production and supporting technology:ultra high speed


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Linked Data

Linked OpenData

Linked Open Drug Data

”Un-Linked” Data



”Un-Linked” Data ”Un-Linked” Data

For the Pharmaceutical Industry For the Pharmaceutical Industry For the Pharmaceutical IndustryFor the Pharmaceutical Industry

Impact areas – e.g. Health data integration on drug developmentImpact areas – e.g. Health data integration on drug development


1

23 4

56

Example Pharma perspective Organization: today, with EDCs Example Pharma perspective Organization: today, with EDCs

EDC without data standards, courtesy Charles Jaffe


Patient recruitment Patient recruitment

• In 2006, the US based Mayo Clinic used EHRs for rapid prospective recruitment of patients with heart failure

• In one study, more than 2900 (2904) heart failure 2900 (2904) heart failure cases were identified in less thancases were identified in less than 24 hours24 hours usinglanguage contained in the EHRs

• These results were also used for predictive modelling and clinical trial design

Ref. (Pakhomov et al. “Electronic Medical Records for Clinical Research:Application to the Identification of Heart Failure”, Am J Management Care. June, 2007)


Demands of interoperabilityDemands of interoperability

Means to share information between disparate information systems in such a way that the information can be used in a meaningful way• Functional• Semantic• Privacy & Security• Legal• Business• Organisational


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Example of moving forward for coordinated action

Example of moving forward for coordinated action

The case of Innovative Medicine Initiative (IMI) and the EHR re-use project


What is IMI?What is IMI?

• Long term public-private partnerships in research at European level (2007-2017)

• Aims• Removing major bottlenecks in drug development,

where research is the key, • Re-invigorate the European bio-pharmaceutical

sector

• Coordinated research efforts responding to industry needs

• Focus on fields of high industrial and policy relevance

• Building on European Technology Platforms• Implemented through new legal entities – Joint

Undertakings (JU)


• A sustainable “business model” for the re-using EHRs in Europe is required • to realize the potential of enhanced research,

development, and safety through the expanded use and interoperability of health information technology

• There is gap between • technology solutions, regional diversity, individual

approaches and the lack of a common viable model across Europe

Problem statement


IMI Call topic no 9 - EHR to Support & Enhance Medical Research IMI Call topic no 9 - EHR to Support & Enhance Medical Research

Project objectiveThe applicant consortium is expected to bring forward innovative approaches to develop:

A model to access, share, and analyze electronic healthcare data to improve medical research and efficiently connect patients to research and development opportunities

through standardised and scalable platform(s)that may include globally accepted standards, processes, systems, technology, organisation models, and principles of governance

that enables healthcare professionals and medical researchers inacademia and industry to re-use healthcare databases

for new discoveries not possible in existing scientific repositories

ensuring that Information is shared in an ethical and safe way,complying with all necessary legal requirements designed to protect patient rights and interests

In a sustainable and scalable wayacross European regions and/or countries


IMI Call topic no 9 - EHR to Support & Enhance Medical Research

Key deliverables of the projectKey deliverables of the project

• A sustainable framework to provide interoperability of EHR data between primary patient care and medical research contexts • focusing on the specific areas of clinical trial protocol feasibility,

patient recruitment, drug safety, and cost effectiveness

• A clear value demonstration through the execution of pilot projects• in the above areas to demonstrate the integrity, security,

performance, and scalability of the platform across European regions and/or countries in an ethical and safe way, complying with all necessary legal requirements designed to protect patient confidentiality

• Providing a forum for emerging EHR initiatives across Europe by enabling the consistent adoption of best practices for the convergence of clinical research and clinical care across Europe


Aim of the IMI EHR project - Sustainable and Scalable Organizational Model Aim of the IMI EHR project - Sustainable and Scalable Organizational Model

• Goal - accredited ”Third party” organisations running on a new scalable and sustainable organisational model to provide services bridging different levels of interoperability between health care and research

Business(e.g. organisational, accreditation, roles)

Functional(e.g. Technology, architecture, tools)

Semantic(e.g. ontology's, standards, languages)

Privacy & security(e.g. legal, sharing, governance)

(e.g. organisational, accreditation, roles)

(e.g. Technology, architecture, tools)

(e.g. ontology's, standards, languages)

Third Party


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New organisational modelNew organisational model

Security

Functional Semantic

Pharma R&D

Third Party

Academic

Health care

Health care

Health care

Business

Pharma R&D


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Scalable Organisational model for EHR re-useScalable Organisational model for EHR re-use


Benefits of re-use of EHRsBenefits of re-use of EHRs• Enhance patient safety• Improve quality of healthcare• Reduce healthcare costs

•Faster drug to market• Enhance access to drug information• Improved personalized treatment capability

PatientsPatientsPatientsPatientsProviders/Health CommunityProviders/Health CommunityProviders/Health CommunityProviders/Health Community

Pharma industryPharma industryPharma industryPharma industryPayers

• Addresses wellness, disease prevention, & disease management • Prevent illness & to adhere to treatment regimens

• Improve targeting the right patient population & indication

• Increase number effective sites & enrollment rate, shorten trial time & cost

• Enhance patient safety

Empower consumers to manage their own health and to work collaboratively with their physicians to prevent illness and to adhere to treatment regimens

Empower consumers to manage their own health and to work collaboratively with their physicians to prevent illness and to adhere to treatment regimens


Joint undertakingJoint undertaking

SustainableOrganisational model

forEHR re-use to Support

Medical Research

SustainableOrganisational model

forEHR re-use to Support

Medical Research

One project consortia

5 years Initiation 2010

EFPIA consortia

Participants may come from:• Academia• SMEs• Healthcare institutions• Patient organisations• Legal & European legislative expertise• Regulatory representatives • Ethics representation• IT companies/vendors• Privacy enhancing technologyvendors• ….• ….

Applicant consortia


Bridging a gap & perfect pitchBridging a gap & perfect pitch

One of the key messages in PriceWaterCooper report onTransforming Healthcare through Secondary Use of Health Data (Oct, 2009)

What it means for your business?“Industry stakeholders are calling for a framework to define public and private sector roles in secondary data use”!

Which is exactly what the IMI EHR project is all about!


CONCLUSIONCONCLUSION

• EHR and health information integration for medical research is opening new possibilities to be a real win-win-win situation for patients, health care and life science industry

• It is a complex undertaking with demands of organizational, legal and technical, semantic, and geographical interoperability requirements

• Technology, is here and integration is feasible to solve many cross-EU issues

• BUT it requires a public private partnership model with an industry wide approach, strong political support, where pharma industry plays an important role

Turning health data into actionable information

on for medical research is opening win situation for patients, health


Thank you for your attentionThank you for your attention


different interoperability needs for clinical research

Health & Medicine

new information landscapefor

use of health information

parties new needs

public health new needs

dataunlinked data new

new demands

key capabilities new

context health data