ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH
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1 ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH! BioMedBridges Annual General Meeting! Dipak Kalra, EuroRec Christian Ohmann, ECRIN Electronic Health Records for Clinical Research! on behalf of the EHR4CR Consortium!
2 Healthcare needs have been changing! CURRENT CHALLENGES IN CLINICAL RESEARCH! Ageing Population! 1 in 9 60! 1 in 5 by There is a requirement for new, safer, more effective medicines in areas of changing medical need! CV! Diabetes! COPD! Asthma! By 2030, 10% of European adults are predicted to have diabetes, compared with 8.5% in 2010! 2 Long-term chronic disease management! HIV/ AIDS!! Number of people (millions)! Number of people (millions) Mental disorders! Number of people with dementia will nearly double every year! 4 Cancer! By 2030, 22.2m new cases of cancer are expected to be diagnosed annually 3! IDF Diabetes Atlas. Fifth edition. Last accessed October 2013! 3. Bray F, Jemal A, Grey N, et al. Global cancer transitions according to the Human Development Index ( ): a population-based study. Lancet Oncol 2012; 13(8): Alzheimer s Disease International. Last accessed October 2013!
3 This need has driven Life Science innovation! CURRENT CHALLENGES IN CLINICAL RESEARCH! A large number of medicines are in development in order to leverage new science expand treatment options improve quality of life provide value for money! Medicines in Development in 2012! personalised medicine! Sequencing of the Human Genome! Source: PhRMA 2012 Profile of the Pharmaceutical Industry!
4 Clinical research is costly, long, complex! Allocation of R&D investments by R&D phase (by %)! CURRENT CHALLENGES IN CLINICAL RESEARCH! 21.5! Pre-human/Pre-clinical! 8.7! Phase I! 12.5! Phase II! 56.9! 35.7! Phase III! Clinical trials! Source: EFPIA. The Pharmaceutical Industry in Figures. 2013! 8.3! 9.8! 3.5! Approval! Pharmacovigilance (Phase IV)! Uncategorized!
5 Patient recruitment a major cause of trial delays! CURRENT CHALLENGES IN CLINICAL RESEARCH! With no searchable patient database, identifying and recruiting suitable patients and trial sites are principal causes of trial delays Delayed trials waste costly resources and slow access to new drugs! The percentage of studies that complete enrolment on time: 18% in Europe, 7% in the US 1! Almost half of all trial delays caused by patient recruitment problems 2! 1. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics, Center Watch, Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia, Business Insights, June Beasley, Recruiting Tufts - Each day a drug is delayed from market, sponsors lose up to $8m 3! 50% of today s clinical trials fail to achieve the target recruitment rate 4!
6 There is growing recognition of the value of re-using EHRs for Clinical Research! CURRENT CHALLENGES IN CLINICAL RESEARCH! In 2010, OECD Health Ministers met in Paris to discuss how to improve value in health care. In their final communiqué, they underlined the importance of better health information systems and called for more and effective use of health data that has already been collected Health data constitutes a significant resource in most OECD countries and it makes economic and ethical sense to use this data as much as possible: to improve population health and to improve the effectiveness, safety and patientcenteredness of health care systems!! OECD, 2013!!
7 A unique initiative! Mandated by IMI One of the largest European public/private partnership projects in this area 4-year project ( ) Budget of >16m! For further information see or contact! Geert Thienpont
8 Brings together key stakeholders! Overcoming' barriers'that' limit'access'to' EHRs'for' research! Offering'a'new' paradigm'for' clinical'research' in'europe! Developing'a' pla=orm'and' services'to're> use'ehr'data! Moving'towards' deployment'of'a' sustainable' ecosystem!
9 Requirements informed by stakeholders! 95% in favour of reuse of EHR data (internal & external stakeholders) Identified issues that need to be addressed Priority services: protocol feasibility, patient identification and recruitment, exchanging data with EHRs for clinical trial data collection, adverse event reporting Interviews with stakeholders helped inform software requirements (Protocol Feasibility Service and Patient Identification and Recruitment Service)! 1. Kalra D, Schmidt A, Potts HWW, Dupont D, Sundgren M, De Moor G, on behalf of the EHR4CR Research consortium. Case Report from the EHR4CR Project: A European Survey on Electronic Health Records Systems for Clinical Research. ihealth Connections 2011; 1(2): ! EU survey! 95% rated compliance with ethical, legal and privacy requirements as the highest, or equal highest driving force for success of EHR4CR 1! 203 respondents from 23 EU countries Pharma, academia, CROs, Patient advocacy groups, Health agencies, IT providers!
10 A win-win for all stakeholders is critical! Pharma, academia, CROs! Clinical trial development will become more efficient by reducing the time it takes to bring new drugs to market, thus generating substantial value! Hospitals! Able to participate in more clinical research programmes, benefiting their patients! Health authorities! Access to new and better evidence to underpin health policy, strategy and resource planning! Health community/ governments Able to offer improved quality of healthcare with reduced healthcare costs! EU More attractive for R&D investment! Patients! Faster access to safe and effective medicines, improving health outcomes across Europe!
11 Results! Different therapeutic areas (e.g. oncology, neuroscience, diabetes, CVS ) Several countries (under different legal frameworks)!
12 Scenario 1: Protocol Feasibility! Protocol design based on estimates and not optimised! With no, or limited access to actual patient data, trial design is based on discussions with expert clinicians Increased amendments, slower than expected enrolment, costly changes to add new sites and countries, even failed trials! A third of protocol amendments are avoidable 1, at a cost of $0.5m per amendment. 2! How long will the trial take?! Will we find sufficient numbers of the right patients?! Do the inclusion/ exclusion criteria make sense?! 1. Drug Information Journal, Vol 45, Industry Standard Research, 2010!
13 EHR4CR information flows for protocol feasibility! EHR4CR! Platform services! Cross-mappings! Hospital A! EHR! protocol! manager! query composer! results! visualizer! AUDIT! feasibility query! aggregated " result set! Query! transformation! cross-maps! standard to local! cross-maps! local to standard! Query results transformation and aggregation! AUDIT! Query orchestrator! store of queries! &! cache of result sets! local query! result! set! query! listener! and! query! performer! query! listener! and! query! performer! AUDIT! local! CDW! or I2B2! or isoft! etc.! Hospital B! ETL! EHR! EHR4CR CDW" dedicated! AUDIT! repository! 13!
14 Example result set for protocol feasibility! 14!
15 Deployed Across 10 Pilot Sites! Registry! Workbench! Endpoint! Seman3cs! Orchestrator! Security!
16 EHR4CR Protocol Feasibility Services!
17 A European inventory of common electronic health record data elements for clinical trial feasibility Justin Doods, Florence Botteri, Martin Dugas, Fleur Fritz and on behalf of EHR4CR WP7 Trials 2014, 15: !
18 Ensure an environment for trustworthy re-use! Segregation of EHR4CR data from EHR! De-identification individual patient anonymous! Control lock/unlock access by hospital! Consolidation only aggregated patient numbers leave the hospital! Governance independent institute ensures data are accessed in a trustworthy way! Electronic Health Records for Clinical Research!
19 Our key design principles! Analyse de-identified health records at participating hospital sites Platform only connected to dedicated repository approved by each hospital for EHR4CR use For protocol feasibility and patient identification/recruitment, only patient counts (totals and sub-totals) are returned from each hospital to the central EHR4CR Platform, never patient level data Platform never stores or communicates data about single data subjects Data about individuals, who might be invited into a study, remain internal to the hospital and abide by its local governance rules Only treating physicians can re-identify candidate patients EHR data is only shared - within the hospital - with a clinical research team if the patient has given that specific consent!
20 Ensuring robust governance! Only approved users are formally registered and given secure log in credentials Users have no means of requesting or obtaining patient level data through the services Even patient numbers are suppressed if the numbers are very low State of the art information security measures are used throughout Audit logs are captured at key communications points: Pharma sites, within the Platform and at hospitals A Code of Practice and Standard Operating Rules will govern the actions of all parties using the EHR4CR services!
21 Scenario 2: Patient recruitment! A major cause of trial delay! With no searchable patient database, identifying and recruiting suitable patients and trial sites are principal causes of trial delays The percentage of studies that complete enrolment on time: 18% in Europe, 7% in the US 1! Almost half of all trial delays caused by patient recruitment problems 2! Each day a drug is delayed from market, sponsors lose up to $8m 3! Delayed trials increase the burden for sites, waste costly resources and slow access to new drugs! 1. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics, Center Watch, Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia, Business Insights, June Beasley, Recruiting Tufts -
22 EHR4CR Patient Recruitment Services! Site tools to Re-use / adapt feasibility query Identify potential candidates Contact treating physicians Evaluate and recruit patients! Manage'Recruitment! Authorize'ParAcipaAon'/''Grant'Access! Contact'TreaAng'Physicians! IdenAfy'PotenAal'Candidates! Evaluate'and'Recruit'PaAents!
23 EHR4CR information flows for patient identification and recruitment! EHR! Hospital A! suitable patients! contacted by! treating clinician! recruitment query for an approved protocol! queries are stored" and may be re-run" periodically to identify" new patients! query! listener,! performer! and! store! AUDIT! local! CDW! or I2B2! or isoft! etc.! pseudo-identifier list! grouped by! treating clinician! re-identified! by treating clinicians! and! EHRs reviewed! for suitability! accrual rates are periodically returned to the sponsor! Recruitment workbench! AUDIT! 23!
24 Scenario 3: Data capture/exchange! Divided patient care & clinical research information leads to inefficiencies! Over! 40%! of clinical trial data are entered into the patient s health record, the clinical trial EDC system, and, possibly, a third paper copy 1! 70+%! of data are perceived by sites as duplicated between EHR and clinical trial systems 2! The result Cumbersome and slow processes Redundant data entry Transcription inconsistencies Source issues! 1. Integrating Electronic Health Records and Clinical Trials: An Examination of Pragmatic Issues, Michael Kahn, University of Colorado. 2. EDC Site Survey: Investigational Site Perspectives on Clinical Trial Information Systems, eclinical Forum Available at: (accessed December 1, 2011).!
25 Results!
26 EHR4CR Economic Analyses! EHR4CR Cost-Benefit Assessment (CBA) To establish the value of EHR4CR services to pharmaceutical industry Perspective of the primary payers Assesses and compares EHR4CR conditions to current practices Central to the EHR4CR value proposition EHR4CR Business Model Simulation To forecast the business results from a EHR4CR service provider perspective Estimated expenses and revenues Results expressed as: Balance sheets (revenues minus expenses) Profitability ratio (revenues divided by expenses)!
27 Model: A free market ecosystem! Data! Provider! An organisation that contributes data for EHR4CR e.g. hospital DATA PROVIDER! DATA PROVIDER! EHR4CR INSTITUTE! Service Provider! Service User! An organisation that provides EHR4CR services to Service Users An organisation that uses EHR4CR services such as a pharmaceutical company or an academic institution! Data aggregation and access services through standard EHR4CR interfaces! Applications access and deliver EHR4CR services! SERVICE USER! NETWORK PROVIDER! SERVICE PROVIDER!!! APPLICATION' APPLICATION' PROVIDERS' PROVIDERS' SERVICE USER! INTERCONNECT! UK DATA! SERVICE USER! SERVICE PROVIDER!!! APPLICATION' APPLICATION' PROVIDERS' PROVIDERS' NETWORK PROVIDER! 1! 2! 3! ONCOLOGY DATA! SERVICE PROVIDER!!! APPLICATION' APPLICATION' PROVIDERS' PROVIDERS' PROTOCOL DESIGN & FEASIBILITY!
28 Role of the EHR4CR Institute! The Institute will promote and govern the use of routinely collected patient-level data for clinical research purposes It will maintain the EHR4CR technical specifications, and contributing some into future standards Through EuroRec it will establish certification procedures for EHR4CR Service Providers and for the capability of EHR systems to support clinical research In partnership with ECRIN and UKCHIP it will accredit clinical research organisations and personnel A formal business model for the Institute shows that this can be sustained and operate with a viable income stream for at least its first five years! Guardian of shared Intellectual Property! Build EHR4CR community and best practices! Specifications and standards! EHR4CR Institute! Promotion of EHR4CR services! Accreditation and Certification! Oversight, governance, auditing!
29 Sustainability: seeding the ecosystem! At project end, there will be A growing network of data providers DATA PROVIDER A! DATA PROVIDER B! First Service Provider(s) Committed service users Institute based in Belgium Oversight and governance Specifications Shared IP Standards EHR4CR INSTITUTE! SERVICE PROVIDER!!! APPLICATION' APPLICATION' PROVIDERS' PROVIDERS' Certification of systems Promotion! SERVICE USER! SERVICE USER!
30 Summary: The EHR4CR project is a large-scale initiative! Bringing together multiple stakeholders Tackling barriers that limit access to EHRs for research Developing a platform and services for the trustworthy reuse of EHR data for clinical Clinical researcher! research! De-identified data for Clinical Research! Patient health records!
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