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Different Interoperability Needs for Clinical Research
 

Different Interoperability Needs for Clinical Research

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Different Interoperability Needs for Clinical Research. Sundgren M. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

Different Interoperability Needs for Clinical Research. Sundgren M. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

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    Different Interoperability Needs for Clinical Research Different Interoperability Needs for Clinical Research Presentation Transcript

    • New needs for interoperability in Clinical Research Mats Sundgren Global Clinical Development AstraZeneca
    • What this lecture is all about ”Discuss aspects of interoperability needs to realise added value of health information - linking patient care, clinical research and public health” New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 2
    • Outline • 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 3
    • The changing face of unmet medical need • 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
    • Pharma Industry Trends R&D spend Dev. times NMEs Sales rma 250 pha for iety Indexed to 1997 e eng or soc 200 R&D spend 150 hall rn f A c ce A con 100 50 NME 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007* • Much more complex • Regulatory requirements • From “Art to Science” • Safety & efficacy • Multidisciplinary • Much larger programs • Parallel work at risk • Hard end-points (outcome • Superior properties required studies) • Safety concerns greater • Value demonstration Source: CMR International & IMS Health
    • Drivers 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 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 7
    • 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 8
    • Challenges • 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 9
    • New Information Landscape For the Pharmaceutical Industry For the Pharmaceutical Industry New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • The 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • The 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • The 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • New Information Landscape For the Pharmaceutical Industry For the Pharmaceutical Industry ”Un-Linked” Data Linked Open Data Linked ”Un-Linked” Data Open Drug Data Linked Data ”Un-Linked” Data New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • Impact areas – e.g. Health data integration on drug development New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 15
    • Example Pharma perspective Organization: today, with EDCs 1 6 5 2 3 4 EDC without data standards, courtesy Charles Jaffe New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 16
    • 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 cases were identified in less than 24 hours using language 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) New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 17
    • Demands 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca
    • Example of moving forward for coordinated action The case of Innovative Medicine Initiative (IMI) and the EHR re-use project New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 19
    • 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) New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 20
    • IMI Call topic no 9 - EHR to Support & Enhance Medical Research Problem statement • 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 21
    • IMI Call topic no 9 - EHR to Support & Enhance Medical Research Project objective The 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 in academia 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 way across European regions and/or countries New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 22
    • Key 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 23
    • 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 Third Party Functional Privacy & security (e.g. Technology, architecture, tools) (e.g. legal, sharing, governance) Semantic Business (e.g. ontology's, standards, languages) (e.g. organisational, accreditation, roles) New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 24
    • New organisational model Pharma R&D Third Party Business Security Pharma R&D Health care Functional Semantic Health care Academic Health care New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 25
    • Scalable Organisational model for EHR re-use New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 26
    • Benefits of re-use of EHRs Providers/Health Community Patients • Enhance patient safety •Faster drug to market • Improve quality of • Enhance access to drug healthcare information • Reduce healthcare costs • Improved personalized treatment capability Empower consumers to manage their own health and to work collaboratively with their Empower consumers to manage their own health and to work collaboratively with their physicians to prevent illness and to adhere to treatment regimens physicians to prevent illness and to adhere to treatment regimens Pharma industry Payers • Improve targeting the right patient • Addresses wellness, disease population & indication prevention, & disease management • Increase number effective sites & • Prevent illness & to adhere to enrollment rate, shorten trial time & cost treatment regimens • Enhance patient safety New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 27
    • Joint undertaking EFPIA consortia Applicant consortia Participants may come from: • Academia • SMEs • Healthcare institutions Sustainable • Patient organisations Sustainable Organisational model Organisational model • Legal & European for for legislative expertise EHR re-use EHR re-use • Regulatory representatives to Support to Support Medical Research • Ethics representation Medical Research • IT companies/vendors • Privacy enhancing technology One project vendors consortia • …. 5 years Initiation 2010 • …. New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 28
    • Bridging a gap & perfect pitch One of the key messages in PriceWaterCooper report on Transforming 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! New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 29
    • CONCLUSION • EHR and health information integration for medical research is opening on new possibilities to be a real win-win-win situation for patients, health win 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 New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 30
    • Thank you for your attention New needs for interoperability in Clinical Research Mats Sundgren AstraZeneca 31