Potential of the use of electronic patient information for clinical research in the pharmaceutical industry The case of the EHR4CR project Mats Sundgren, AstraZeneca Coordinator 1
Outline Problem statement The EHR4CR project Scaling up towards a pan-european platform supporting clinical research Champion Program with Efpia companies Governance via The European Institute for Innovation through Health Data www.ehr4cr.eu 2
PROBLEM STATEMENT 3
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, safety reporting De-identified data for Clinical Research Patient health records 4
Improved access to health record data will speed up protocol design, patient recruitment, data capture & safety reporting 5
The burden of running a clinical trial has increased Protocol design Trials have become increasingly complicated More endpoints to observe as science has expanded knowledge about how to measure safety and effectiveness Patient recruitment Larger on average and require more participants. Recruitment has become more difficult and expensive Data capture and exchange More data collected, more routine more work THE GROWING COMPLEXITY OF CLINICAL TRIALS Unique Procedures per Trial (median) Total Procedures per Trial (median) Clinical trial Staff Work Burden (measures in work-effort units) 1999 2005 % Change 24 35 46% 96 158 65% 21 35 67% Length of Clinical Trial (days) 460 780 70% Clinical Trial Participant Enrolment Rate Clinical Trial Participant Retention Rate 75% 59% -21% 69% 48% -30% Source: PhRMA Report 2010 6
THE PROJECT 7
The EHR4CR project EHR4CR Electronic Health Records for Clinical Research 4+1 year project (2011-2016), 35 partners, budget >17M Objectives & Scope Provide a platform for trustworthy re-use of EHR data to support innovation in clinical research and healthcare operations. Unlocking Real World Data for optimising clinical trials. Status Extended into 2016 for making the transition to a sustainable platform. Initiating a Champion Programme, connecting hospitals to an operational platform, building up experience with pharma. The European Institute for Innovation through Health Data an independent governance body. For more information: http://www.ehr4cr.eu/ 8
The EHR4CR objective Research and develop a trustworthy service platform able to unlock clinical information stored in EHRs for improving clinical research Clear focus on three (3) relevant use cases PROTOCOL FEASIBILITY PATIENT RECRUITMENT DATA CAPTURE AND EXCHANGE SAFETY REPORTING Enabling protocol testing with real world data in potential trial sites rather than with guestimates. Speeding up recruitment by making EHR data searchable for investigators and establishing a unified communication path between sponsors and sites. Facilitating EHR data extraction for applications used during trial execution (e.g. prefilling of CRFs and of SAE reports). 9
Brings together key stakeholders 35 participants including pharmaceutical industry, academia, hospitals, SMEs, patient associations and public authorities 10 Pharma Companies 11 hospital sites Advisory boards and other experts 10
Status of the EHR4CR project EHR4CR - IMI research project Project pilots Feasibility & Recruitment 12 studies, different therapeutic areas De-identified data from >500k patients over 11 sites Pilot hospitals 11 major hospitals in 5 countries. Germany (WWU, FAU) France (AP-HP, U936) UK (UoD, UoG, UoM, UCL, KCL) Switzerland (HUG) Poland (MuW) Scaling up the solutions! Technology Operations Governance Sustainability Operational pan- European platform Operational pan-european platform EHR4CR Champion Program Permanent network of clinical sites giving access to millions of patients in close to real time Trial design and recruitment supported by real-world evidence on a European scale Governance by the with European Institute for Innovation through Health Data 11
THE PLATFORM AND SERVICES 12
The EHR4CR platform Site dependent process (Virtual) appliance Centrally deployed (Saas/Paas) Application Services ETL Messaging Platform Management AuthN Local Applications NO patient data leaves the hospitals! Terminology Services Semantic interop. Mapping... Workflow Security AuthZ Audit 13
The EHR4CR platform dataflow HOSPITAL/DATA PROVIDER #Counts >> Enabled Recruitment Progress >> EHR4CR PLATFORM Protocol feasibility service Central Feasibility & Recruitment Workbench << Queries << Clinical Trial RESEARCH CENTRE e.g. pharmaceutical company ETL #Counts >> Trial Candidates Recruitment Workbench Recruitment Progress >> Patient recruitment service 14
Evolution towards a mature platform service EHR4CR proof of concept Other know-how & experiences Custodix commits to being an EHR4CR service & platform provider 15
InSite Clinical Platform overview Protocol Feasibility Service Patient Identification and Recruitment Service Central Platform Site Management Central service available to researchers Computer assisted patient recruitment application Cohort selection and analysis tool Site Services Installed and used inside the hospital 16
InSite central platform screenshot PFS Authoring criteria (queries) Clinical concept quick search Designing feasibility queries (i.e. eligibility criteria ) Clinical concepts to design queries with (ICD, LOINC, SNOMED, etc.) 17
InSite central platform screenshot PFS viewing results Site summary Country summary 18
SCALING UP: TOWARDS A PAN-EUROPEAN PLATFORM SUPPORTING CLINICAL RESEARCH 19
2015 2016 Champion Programme A multi-stakeholder collaboration aiming to accelerate and ensure the future of clinical research in Europe. The Champion Programme serves to Further validate and improve technology Define (refine) the rules of engagement for a sustainable ecosystem Start building a network of hospitals Engage with European Institute for Innovation through Health Data which aims to govern the EU data re-use ecosystem 20
Value for pharma & research organisations Clear value proposition for research organisations Better trial design Optimising clinical protocol design will reduce costly corrective measures such as protocol amendments, late addition of new trial countries or sites. Quicker achieved recruitment targets Computer assisted patient identification tools result in accelerated identification, fewer patients missed, Overall increased efficiency Further automation and optimisation of the clinical trial process by use of a central platform result in an overall increased efficiency. Improve trial success rate The number of trials failed due to failure to recruit will be reduced. Reduce cost Less manual work, less corrective measures, etc. lead automatically to a decrease in total trial cost. Pharma will also avoid the expense and time and effort of opening trial sites which will not yield enough patients. Increase revenue The platform will reduce the elapsed clinical trial time, which in the end translates into a quicker time to market and thus additional revenue (increased time on market under patent protection). 21
Value for hospitals Value generated at multiple levels: clinical research, overall care provision and revenue Better patient care Increased income Access to tools Better quality data Enhanced reputation More patients will get access to trial drugs and innovative care pathways at no additional cost to the hospital. Physicians participating in clinical trial are in general more up to date with medical science. Cutting cost will no longer be sufficient to deal with the overall healthcare budget decrease. Hospitals need to search for new revenue streams, the clinical trial platform will help them to attract more trials and thus income. Participation to the clinical trial platform includes free access to a set of tools to explore and analyze patient data. Anyone familiar with the cost of clinical IT systems understands the value of this benefit. The clinical trial platform stimulates hospitals to focus on the quality of their data. Improved monitoring, performance benchmarking, reporting and management (e.g. reimbursement coding) drives optimization of patient care and improved internal management. Hospitals and their physicians participating in more clinical trials will get greater visibility in scientific community. Which on its turn will attract more research (trials), topclass physicians and more patients (once reputation gets picked up by the media). 22
THE GOVERNANCE 23
Governing the EHR4CR ecosystem The needs Educate and train research and ICT staff Accredit staff and organisations Certify service providers and EHR systems Oversee and audit governance & security RESEARCH SPONSOR ICT SOLUTION PROVIDERS RESEARCH ORGANISATIONS SERVICE USER RESEARCH SPONSOR SERVICE USER EHR4CR SERVICE PROVIDER LOCAL PROVIDERS LOCAL PROVIDERS PLATFORM PROVIDER OTHER DATA AGGREGATORS DATA PROVIDER DATA PROVIDER shared by multiple research projects
i~hd has been formed because a complementary, neutral and not-for-profit organisation is needed to play a central role in governing and expanding a trustworthy health data driven ecosystem including EHRs and EHR4CR platform services; to act as a connector between health care and clinical research standards, that are presently developed in silos and impair the interoperability and pooling of health data for research; to promote the adoption of healthcare standards and of data quality, to enable more effective, safer and better integrated healthcare; to promote to society the importance of using health data for research, to improve efficiency through reduced duplications, delays, costs enhance speed and efficiency in clinical studies. 25
Clinical Research needs Healthcare needs Harmonised health information and standards Best practices in information governance Solutions for better quality health data, and legitimate uses of data Quality assessments, certification and audit Intelligence derived from health data e.g. research, outcomes Value Assessment programmes
Building synergy and consensus i~hd will act as a focal point bringing stakeholders together to share experiences, agree common priorities and approaches, working towards convergence and cross-fertilisation between: Patient associations Citizen, family and carer associations Health professional associations Clinical and informatics academia Healthcare providers National decision makers Third party payers, commissioners EHR system and applications vendors Medical Device vendors Pharma, Bio-tech Health data aggregators and consumers Regulators Standards development organisations (SDO) Multi-national decision makers Social care providers Electronic health (ehealth) competence centers 27
i~hd will provide an essential governance framework for the scale up of EHR4CR and future research platforms across Europe certifying research platforms and service providers establishing codes of practice and privacy protection policies conducting audits and investigating any concerns about security and privacy educating the public of the value of using health data for research and assuring them about the governance protecting their privacy support better quality and interoperability of health data establishing a Network of Excellence amongst data providers to improve data quality identifying ICT mature data sources e.g. hospitals facilitating alignment amongst standards bodies, especially in semantic interoperability, ensuring that future standards prioritise clinical and research needs 28 2 8
CLOSER LOOK AT CHAMPION PROGRAM 29
Initial services Starting with a simple service offering for Research Organisations Initial focus is on building the network and introducing the technology in hospitals The two services should be able to demonstrate the value of this initiative to all stakeholders Piloting new services will be done as the need arises The service offering will be expanding as the technology matures Protocol feasibility services Optimise protocol eligibility criteria by instantaneously testing them out in multiple sites in various countries Directly identify the countries and specific sites to approach for participation Trial recruitment services Distribute trial protocols over multiple sites in a uniform way Track recruitment progress in real time Optimal recruitment due to tools provided to hospitals Protocol Feasibility services cover a broader application domain than expected from the name. The service allows patient populations, hospitals and databases to be remotely and securely clinically assessed (distributed query). These services are invaluable for trial design, site selection, pharmaco-economics, etc. 30
Efpia Champion Programme summary The Champion Programme is designed to provide a low-risk entry for all stakeholders into this innovative approach to efficient use of Real World Data. It is a key step in building the EHR4CR envisaged ecosystem of network of hospitals, service providers and pharma users. Objectives Validating and further improving the platform together with Custodix (first Service and Platform Provider) by connecting 15-30 hospitals during 2015-2016. Define (refine) the rules of engagement for a sustainable ecosystem (including defining the governance role of the European Institute of Innovation in Health Data). Scope Evaluate platform services for Protocol Feasibility, Patient Identification & Recruitment across multiple therapeutic areas (TAs) with a broad geographical coverage in Europe and reaching out to the US. Outcome A proven ecosystem for acceleration of clinical research through Real World Data, ready to further expand geographically and data source wise (registries, research data bases, PHR, mhealth apps data, ) Status 6 EFPIA Champion companies (Amgen, AZ, Bayer, Janssen, Roche, Sanofi) constitute the core Efpia Champions Initiation autumn 2015 31
The EHR4CR project is an important initiative Bringing together multiple stakeholders Overcoming barriers that limit access to EHRs for research Clinical researcher Developing a platform and services for trustworthy re-use of EHR data within and outside Europe De-identified data for Clinical Research Patient health records 32
Summary First important steps from an European Private Public R&D project...towards an entirely new collaboration model that have a potential to become a game changer in the clinical research world Exiting times ahead! 2015 2016 2017 Hospital Champions EFPIA Champion(s) Partnerships 33
InterSystems & Custodix partnership data metadata Pilot in Lille (FR) Accelerating InSite installation through integration with HealthShare and TrakCare Enriching data though use of iknow Studies & queries Aggregated query results Query service Central Platform Reference terminologies & terminology mapping 34
Thank You! Contact us: comms@ehr4cr.eu 35