Expectations of the Pharma Industry Regarding EHR Systems 24 November 2018 Expectations of the Pharma Industry Regarding EHR Systems Helsinki Country: Finland Did You Know? Santa Claus Northern lights Lapland Ice Hotel Saunas Helsinki ( listen (help·info); Swedish: Helsingfors, listen (help·info)) is the capital and largest city of Finland. It is in the southern part of Finland, on the shore of the Gulf of Finland, by the Baltic Sea. The population of the city of Helsinki is 577,928 (28 February 2009),[2] making it the most populous municipality in Finland by a wide margin. The foreign-born population stands at around 10%. Helsinki, along with the neighbouring cities of Vantaa (Vanda), Espoo (Esbo), and Kauniainen (Grankulla), constitutes what is known as the capital region, with over 1,000,000 inhabitants. The Greater Helsinki area contains 12 municipalities and has a population of over 1,300,000.[2] The Greater Helsinki accounts for a quarter of the population of Finland, 29% of jobs, and a third of the GDP. Helsinki is Finland's capital for business, education, research, culture, and government. Greater Helsinki has eight universities and six technology parks.[6] Some 70% of foreign companies operating in Finland have settled in the Helsinki region.[6] The immigration of rural residents has made it one of the fastest growing metropolitan areas in Europe. Finland's main international airline hub, Helsinki-Vantaa Airport is 40 minutes from the city center, with direct flights around the world. The busy Helsinki–Tallinn route takes 1.5 hours by sea and 18 minutes by helicopter. Two other big cities in Finland, Tampere and Turku, can be reached in 1.5–2 hours by train[7] and 1.5–2.5 hours by car. In early 2009, Helsinki has started contemplating a possible merger with Vantaa. On 30 March 2009, the city council of Vantaa agreed to do a review of Helsinki's proposal of a possible merger. The city council emphasises that the review is not about a possible discontinuation of the city of Vantaa.[8] Richard Perkins eClinical Forum Tallinn June 2010 Copyright eClinical Forum 2008

The Impact of eHealth on Clinical Trials 24 November, 2018 Overview… Introduction Use of EHRs in CR Protocol Optimisation Data Capture and Provision A Different Future Why Now EHRCR How EHRs are used today and their future potential for Clinical Research 24 November, 2018 Copyright eClinical Forum 2010 Copyright ConSept Consulting 2008

Introduction… EHR Growth to >50% ConSept Consulting Saturday, 24 November 2018 Introduction… Physician / Investigator Healthcare EHR Growth to >50% Enhance patient safety Improve quality of healthcare Reduce healthcare costs 67-92% Source: Benchmarking ICT use among General Practitioners in Europe, April 2008 EU GPs (2008) Pharma Research Bringing a new treatment to the market costs >800 M Euro and increases at ~10% a year Clinical research uses 55-75% of R&D budget >10,000 EU Clinical Trials Copyright eClinical Forum 2010

Protocol Optimisation… Use of EHR Data to… 58% of trials do not meet projected recruitment rates! 49% increase in trial procedures 54% increase in trial workload Pharma Research Evaluate patient populations Optimise inclusion/exclusion criteria Assess feasibility of countries/sites Patient identification (site) The Challenge… 250,000 patients participate in European clinical trials a year Recruited by 4200 investigators Healthcare Limited data that may not be representative Difficulty to query (different formats) Cost and time 24 November, 2018 Copyright eClinical Forum 2010

Data Capture… The Shift to EDC… Pharma Research Clinical Research has moved from capturing data on paper to electronic data capture at the site Systems used for clinical research have to fulfill strong regulatory requirements Entry of Patient’s Clinical Data Physician / Investigator 24 November, 2018 Copyright eClinical Forum 2010

Data Capture… Growth in Electronic Data Capture to 61% of ongoing trials (from 13% in 2001!) … Average of 61% of trials ongoing at respondent sites use EDC To provide faster, better quality and more reliable data to support safety and efficacy 37% only use EDC In parallel the use of EDC has grown substantially in the last 8 years driven by our desire to improve clinical trial performance – for us! Today 61% of ongoing trials in Europe (in the online survey sample used some form of EDC). 37% of responders are only doing EDC trials (grown from 8% in 2001). 9% aren’t currently participating in current EDC trials (73% in 2001) No EDC Trials All EDC Trials Source: eClinical Forum Site Survey 2009, European data N=131 24 November, 2018 Copyright eClinical Forum 2010

Data Capture… EHR Healthcare Pharma Research Physician / Investigator Entry of Patient’s Clinical Data EHR Physician / Investigator 7 24 November, 2018 Copyright eClinical Forum 2010

The Impact of eHealth on Clinical Trials 24 November, 2018 Data Capture… Healthcare and Pharma-centric Use of Technology is Creating an Source Issue for Clinical Trials Traditional Current Research information is copied from healthcare records to pCRF. Healthcare retain source Research information is copied to an electronic research environment. Sometimes with an interim paper step and hosting to provide healthcare ‘source’. The Current Environment Results In… Redundant data entry, inefficiency, reliability issues… Source Data Source Data Paper Medical Record Electronic Medical Record Paper CRF eCRF But … ~30% of all clinical trials currently use EDC Typical site may have 3 different EDC systems Transcription from paper or electronic charts to EDC results in extensive duplication of data entry (~50%) Replacement of backend Increasing functionality (no longer Electronic ‘Data Capture’) Trial Data and Hosting Paper CRF 24 November, 2018 Copyright eClinical Forum 2010 Copyright ConSept Consulting 2008

The eSource issue needs to be resolved Data Capture… The eSource issue needs to be resolved 13% of data for the EDC trial was first entered into the eCRF and is therefore ‘source’ within the EDC system But… 11% of data was entered into a pCRF probably created to record source trial data not part of the patient’s site record 24 November, 2018 Copyright eClinical Forum 2010

Copyright eClinical Forum 2010 ConSept Consulting Capabilities 11/24/2018 Data Capture… and… The percentage of patient data perceived as entered into EDC system and the patient record? In your opinion what percentage of data that was entered into the CRF was also entered into the patient file or notes? 70-100%! A significant opportunity for efficiency gains! Source: eClinical Forum Site Survey 2009, European data 24 November, 2018 Copyright eClinical Forum 2010 10

Data Capture… Healthcare Pharma Research Source data held in EHR may not be appropriate as source for regulated clinical studies … Entry of Patient’s Clinical Data EHR Various standards, levels of system validation and integration, data structure depending on country, region, institution. Systems validated & compliant to Industry & Regulatory standards & policies e.g. CSUCI, ICH GCP Physician / Investigator 11 24 November, 2018 Copyright eClinical Forum 2010

Data Capture… Data Errors… Many healthcare professionals and researchers wonder why the different electronic sources can’t be linked This would avoid… Reduce redundant data entry Avoid data transcription errors Clarify the ‘source issue Use a familiar system Healthcare Completing ~1400 data points per patient A typical trial has 6000 data queries (time and cost to correct) Pharma Research Cost of handling data queries - €60 million 24 November, 2018 Copyright eClinical Forum 2010

Copyright eClinical Forum 2010 24 November, 2018 A Different Future… Imagine… Patient Data Exchange Between Healthcare and Drug Development Systems Emerging and Future EHR-Research Connectivity and Complexity Clinical Trial System Healthcare System Integrated Future Current Divided Interoperable Ideal Integrated Future EHRs used to… Evaluate Patient Populations Accelerate Patient Recruitment Capture CT Data Exchange CT Data The EHR becomes the patient data repository Current Divided EHR systems holding source for data used in clinical trials may not meet essential regulatory requirements Clinical care data required for clinical trials is entered into EHR and into clinical trial systems Research holds source data not part of normal clinical care Redundant data entry, transcription errors and source issues cost healthcare and industry time and money. Interoperable Ideal EHR and research systems work seamlessly together so that groups benefit from data access and mining capabilities across healthcare and research data sets Research systems and healthcare systems sit on the same spine Systems conform to the same data exchange standards 24 November, 2018 Copyright eClinical Forum 2010 Copyright eClinical Forum 2009

Copyright eClinical Forum 2010 A Different Future… Benefiting all stakeholders… Healthcare Identification of target population Reduced effort for data provision leaves more time for patient care Simplified safety reporting and management Potential to conduct more research Familiarity of one interface Patient New innovative therapies available earlier Higher quality data provides greater safety Real-time identification of safety issues and trends Authorities Higher quality, reliable data from validated sources under investigator control Lower cost and faster approval of new therapies Mining of data PharmaResearch Evaluation of trial criteria for concept development and trial feasibility improves trial success Linking of patients to trials to improve patient recruitment Early identification of safety issues and trial termination improves patient safety Data handling efficiencies Virtual trials … 24 November, 2018 Copyright eClinical Forum 2010

Copyright eClinical Forum 2010 A Different Future… Connect Healthcare and Research … For more efficient use of patient data, to avoid redundant entry and to improve trial performance 72% of investigational sites consider connecting healthcare and clinical trial systems to be of benefit! Of Benefit Source: eClinical Forum Site Survey 2009, European data 24 November, 2018 Copyright eClinical Forum 2010

Munich (InferMed: Siemens) Why Now… Political, Cultural & Technical Solutions are Starting to Bridge the Gap Political Removing obstacles, linking stakeholders and driving the need for change FP7 ICT IMI BRIDG EHRCR Future Connected Healthcare & Research Standards Common data standards allow movement of data between healthcare and research Systems Reliable, validated systems meet healthcare and research requirements Process Controlled process for release and transfer of data meets bio-ethical requirements Cultural Stakeholders see CR as a special case for use of EHR data Munich (InferMed: Siemens) Re-Use Technical Projects are developing solutions to individual components The concept has been proven in single site, technology instances PACER 24 November, 2018 Copyright eClinical Forum 2010

Making It Happen… EHRCR August 2007 Making It Happen… EHRCR It is an important project to: Remove risk of clinical trial data rejection because of unreliable source data Provide EHR system developers with the business case and the clinical research functionality Help healthcare system implementers understand the operational functionality required Provide sponsors and certification bodies with the basis for evaluating EHR systems It is an important project to: Remove risk of clinical trial data rejection because of unreliable source data (e.g. FDA rejection letter 2006) Provide EHR system developers with the business case and the clinical research functionality to be incorporated into their systems Help healthcare system implementers understand the operational functionality required for regulated clinical research – ‘CR Ready’ Provide sponsors and certification bodies with the basis for evaluating EHR systems as source data repositories EDC/eSource Taskforce 24 November, 2018 Copyright eClinical Forum 2010 17

Making It Happen… EHRCR EuroRec EHRCR Functional Profile ANSI Standard EHRCR FP CEN Standard EHRCR FP EU Certification of EHRs for Clinical Research CCHIT Certification of EHRs for Clinical Research Clinical Research Regulations & Guidances EHRCR User Requirements UR Mapping Table HL7 EHRCR Functional Profile 24 November, 2018 Copyright eClinical Forum 2010

Copyright eClinical Forum 2010 Key Messages… The Pharma industry has always used PHR data for clinical research (informed consent, anonymous, ethics committees) The growth of EHR presents opportunities for Research to improve clinical trial performance Healthcare to reduce redundant data entry The environment is right to actively support and make change happen There are challenges but they can be met by adapting and integrating existing technologies and standards to achieve interoperability The EHRCR project is an important initiative to communicate functionality for Clinical Research The concept has already been proven in single site and technology pilots There is a political expectation for integration of healthcare and pharma/academic data (FP7 ICT, IMI) 24 November, 2018 Copyright eClinical Forum 2010

Copyright eClinical Forum 2010 Any Questions… 24 November, 2018 Copyright eClinical Forum 2010

Expectations of the Pharma Industry Regarding EHR Systems 24 November 2018 Expectations of the Pharma Industry Regarding EHR Systems Helsinki Country: Finland Did You Know? Santa Claus Northern lights Lapland Ice Hotel Saunas Helsinki ( listen (help·info); Swedish: Helsingfors, listen (help·info)) is the capital and largest city of Finland. It is in the southern part of Finland, on the shore of the Gulf of Finland, by the Baltic Sea. The population of the city of Helsinki is 577,928 (28 February 2009),[2] making it the most populous municipality in Finland by a wide margin. The foreign-born population stands at around 10%. Helsinki, along with the neighbouring cities of Vantaa (Vanda), Espoo (Esbo), and Kauniainen (Grankulla), constitutes what is known as the capital region, with over 1,000,000 inhabitants. The Greater Helsinki area contains 12 municipalities and has a population of over 1,300,000.[2] The Greater Helsinki accounts for a quarter of the population of Finland, 29% of jobs, and a third of the GDP. Helsinki is Finland's capital for business, education, research, culture, and government. Greater Helsinki has eight universities and six technology parks.[6] Some 70% of foreign companies operating in Finland have settled in the Helsinki region.[6] The immigration of rural residents has made it one of the fastest growing metropolitan areas in Europe. Finland's main international airline hub, Helsinki-Vantaa Airport is 40 minutes from the city center, with direct flights around the world. The busy Helsinki–Tallinn route takes 1.5 hours by sea and 18 minutes by helicopter. Two other big cities in Finland, Tampere and Turku, can be reached in 1.5–2 hours by train[7] and 1.5–2.5 hours by car. In early 2009, Helsinki has started contemplating a possible merger with Vantaa. On 30 March 2009, the city council of Vantaa agreed to do a review of Helsinki's proposal of a possible merger. The city council emphasises that the review is not about a possible discontinuation of the city of Vantaa.[8] Richard Perkins President, eClinical Forum Tallinn June 2010 Copyright eClinical Forum 2008

About the eClinical Forum… A not-for-profit and non-commercial association 55 companies from Pharma R&D, service industries (eClinical system vendors, CROs, consultancies etc), academia, EHR. European & North American Activities cover electronic data acquisition, processing and use for clinical research Share experiences, develop public domain deliverables and to shape the future of the clinical research environment Contributes Extensively To Information In The Public Domain Surveys … Industry status and trends, performance metrics, investigator attitudes, auditing experiences, system capabilities Reports … Business value of EDC; eSource, Connecting Healthcare & Research Tools … RFI development; Technology scale up Knowledge … eHealth terminology; Mobile data collection formed in 2000 and registered in France