EHR4CR AN INNOVATIVE PLATFORM AND BUSINESS MODEL ACDM Annual Conference, 9 Richard Perkins, eclinical Forum Electronic Health Records for Clinical Research 1 Industry-centric growth in ICT 57% of R&D investment is within Clinical Development 1 Clinical trial research data Electronic data capture of Clinical Trial data Physician / Investigator Over 40% of clinical trial data are entered into health record and EDC 1 Patient Care Data Patient health records In some countries nearly 90% of all healthcare records are digital The inefficiencies become obvious at the clinical trial interface 1. Integrating Electronic Health Records and Clinical Trials: An Examination of Pragmatic Issues, Michael Kahn, University of Colorado. Electronic Health Records for Clinical Research 2 Copyright EHR4CR 2014 1
There is a need to bridge the gap We have imagined an environment where de-identified patient data can be re-used within healthcare and research for clinical research purposes Across countries Across systems Across sites to speed up protocol design, patient recruitment, data capture De-identified data for Clinical Research Patient health records Electronic Health Records for Clinical Research 3 A win-win for all stakeholders is key 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 Electronic Health Records for Clinical Research 4 Copyright EHR4CR 2014 2
The EHR4CR Project brings together stakeholders Electronic Health Records for Clinical Research 5 Deliverables Technical Platform Model A Set Of Tools And Services 1. Protocol Feasibility 2. Patient Identification and Recruitment 3. Clinical Trial Data Exchange Validated Through Pilots Different therapeutic areas (e.g. oncology, neuroscience, diabetes, CVS ) Several countries (under different legal frameworks) Electronic Health Records for Clinical Research 6 Copyright EHR4CR 2014 3
Scenario 1: Protocol Feasibility Protocol design based on estimates and not optimised PROTOCOL FEASIBILITY 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, 2011 2. Industry Standard Research, 2010 Electronic Health Records for Clinical Research 7 EHR4CR Protocol Feasibility Services PROTOCOL FEASIBILITY Protocol Feasibility Services Central Workbench Electronic Health Records for Clinical Research 8 Copyright EHR4CR 2014 4
Deployed Across 10 Pilot Sites PROTOCOL FEASIBILITY Registry Workbench Endpoint Semantics Orchestrator Security Electronic Health Records for Clinical Research 9 Scenario 2: Patient recruitment A major cause of trial delay PATIENT RECRUITMENT 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 With no searchable patient database, identifying and recruiting suitable patients and trial sites are principal causes of trial delays 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, 2008. 2. Study Participant Recruitment and Retention in Clinical Trials: Emerging strategies in Europe, the US and Asia, Insights, June 2007. 3. Beasley, Recruiting 2008 4. Tufts -http://clinicalperformancepartners.com/wp-content/uploads/2012/07/fixing-feasibility-final-jan-2012.pdf Electronic Health Records for Clinical Research 10 Copyright EHR4CR 2014 5
EHR4CR Patient Recruitment Services Patient Recruitment Services Local Workbench PATIENT RECRUITMENT Site tools to Re-use / adapt feasibility query Identify potential candidates Contact treating physicians Evaluate and recruit patients Authorize Participation / Grant Access Manage Recruitment Identify Potential Candidates Contact Treating Physicians Evaluate and Recruit Patients Electronic Health Records for Clinical Research 11 Scenario 3: Data capture/exchange WORK IN PROGRESS DATA CAPTURE 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 2009. Available at: www.eclinicalforum.org (accessed December 1, 2011). Electronic Health Records for Clinical Research 12 Copyright EHR4CR 2014 6
Deliverables Technical Platform Model Towards Sustainability 1. A self-sustaining economic model 2. A roadmap for pan-european adoption Electronic Health Records for Clinical Research 13 Model: A free market ecosystem Data Provider An organisation that contributes data for EHR4CR e.g. hospital DATA DATA EHR4CR INSTITUTE Service Provider An organisation that provides EHR4CR services to Service Users Data aggregation and access services through standard EHR4CR interfaces NETWORK INTERCONNECT NETWORK Applications access and deliver EHR4CR services 1 UK DATA 2 ONCOLOGY 3 DATA PROTOCOL DESIGN & FEASIBILITY Service User An organisation that uses EHR4CR services such as a pharmaceutical company or an academic institution USER USER USER Electronic Health Records for Clinical Research 14 Copyright EHR4CR 2014 7
Model: Value Propositions Cost-Benefit Assessment (CBA) To establish the value Compare EHR4CR conditions to current practice Model Simulation To forecast business results Balance sheets revenues minus expenses Profitability ratio revenues divided by expenses Inputs Volumes Time Effort Cost Growth Swift and scalable market penetration Robust Methodology Monte Carlo Simulations Efficiency Gains reduction in the man-time and costs for protocol feasibility, patient identification & recruitment, and study conduct EHR4CR Services Validation experts opinions Profitability and Sustainability Electronic Health Records for Clinical Research 15 Road Map: Seeding the system At project end there will be A growing network of data providers First Service Provider(s) Committed service users Institute based in Belgium Oversight and governance Specifications Shared IP Standards Certification of systems Promotion EHR4CR INSTITUTE DATA A USER DATA B USER Electronic Health Records for Clinical Research 16 Copyright EHR4CR 2014 8
Road Map: Engagement with stakeholders Stakeholder Engagement Conference in Brussels April 8 th Satellite event for Pharma April 9 th Key event with European hospitals April 10 th Satellite event for potential service providers Electronic Health Records for Clinical Research 17 Summary: The EHR4CR project is an important initiative Bringing together multiple stakeholders Overcoming barriers that limit access to EHRs for research Developing a platform and services for trustworthy re-use of EHR data Offering a new paradigm for clinical research in Europe De-identified data for Clinical Research Clinical researcher Patient health records Electronic Health Records for Clinical Research 18 Copyright EHR4CR 2014 9
Any Questions Electronic Health Records for Clinical Research 19 Copyright EHR4CR 2014 10