Enabling Clinical Research
 Through Effective Use Of
       Patient Data
  Perspective of the Researcher

            Rich...
Overview…

                  1. Some Relevant Statistics
To understand
                  2. A Different Future
 the ration...
Some Relevant Statistics…

       Pharma Research                           Healthcare
 Bringing a new treatment          ...
Some Relevant Statistics…

      Growth in Electronic Data Capture to 61% of
      ongoing trials (from 13% in 2001)…
    ...
Some Relevant Statistics…

Growth of EHRs to >50% …
– Enhance patient safety
– Improve quality of healthcare              ...
Some Relevant Statistics…

and… The percentage of patient data perceived
as entered into EDC system and the patient
record...
A Different Future…

We Need…
a common
understanding
and approach
We Need…
to connect
Healthcare and
Pharma/Academic
Resea...
A Different Future…

Connect Healthcare and Research …
For more efficient use of patient data, to avoid redundant
entry an...
A Different Future…

        Imagine… Patient Data Exchange Between Healthcare
                                           ...
A Different Future…
  Benefiting all stakeholders…

                                    Healthcare
                       ...
The Challenge…
 Healthcare                                                         Pharma Research
            Multiple sy...
Why Now…

Political, Cultural & Technical Solutions are
Starting to Bridge the Gap
1. Political                       FP7 ...
How EHRs Could Enhance CR…
                          Via a standardised, scalable platform that connects
                 ...
How EHRs Could Enhance CR…

… operating within a sustainable business model
                                              ...
Key Messages…

1. The more efficient re-use of EHR data presents
   opportunities for
  •   Healthcare to reduce redundant...
Key Messages…

5. There are challenges but they can be met by
   adapting and integrating existing technologies
   and sta...
Enabling Clinical Research
 Through Effective Use Of
       Patient Data
  Perspective of the Researcher

            Rich...
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Perspective of the Researcher. Perkins R. eHealth week 2010

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Perspective of the Researcher. Perkins R. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

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Perspective of the Researcher. Perkins R. eHealth week 2010

  1. 1. Enabling Clinical Research Through Effective Use Of Patient Data Perspective of the Researcher Richard Perkins President, eClinical Forum
  2. 2. Overview… 1. Some Relevant Statistics To understand 2. A Different Future the rationale, needs, 3. The Challenge challenges, potential 4. Why Now solutions… 5. How EHRs Could Enhance Clinical Research 2
  3. 3. Some Relevant Statistics… Pharma Research Healthcare Bringing a new treatment 250,000 patients participate in to the market costs >800 M European clinical trials a year Euro and increases at Recruited by 4200 investigators ~10% a year Completing ~1400 data points Clinical research uses 55- per patient 75% of R&D budget A typical trial has 6000 data >37,000 Clinical Trials queries (time and cost to 58% of trials do not meet correct) projected recruitment Generates 525-2025 M Euro for rates! healthcare Physician / 3 Investigator
  4. 4. Some Relevant Statistics… Growth in Electronic Data Capture to 61% of ongoing trials (from 13% in 2001)… 40% Average of 61% 35% of trials ongoing ‒ To provide faster, at respondent 30% sites use EDC better quality and % Responders 25% more reliable data 20% 37% only use EDC to support safety 15% and efficacy 10% 5% 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Percentage of EDC Trials Ongoing at Site No EDC Trials All EDC Trials Source: eClinical Forum Site Survey 2009, European data N=131 4
  5. 5. Some Relevant Statistics… Growth of EHRs to >50% … – Enhance patient safety – Improve quality of healthcare EU Hospitals (2004) – Reduce healthcare costs 50% EU GPs (2008) 67-92% Source: Personal communication - ICT use among Hospitals in Europe, 2004 5 Source: Benchmarking ICT use among General Practitioners in Europe, April 2008
  6. 6. Some Relevant Statistics… and… The percentage of patient data perceived as entered into EDC system and the patient record? 70% In your opinion what percentage of data that was 60% entered into the CRF was also entered into the patient file or notes? % Responders 50% 70-100%! 40% 30% 20% A significant 10% opportunity for 0% 0 10 20 30 40 50 60 70 80 90 100 efficiency gains! Percentage Duplicated n = 124 Source: eClinical Forum Site Survey 2009, European data 6
  7. 7. A Different Future… We Need… a common understanding and approach We Need… to connect Healthcare and Pharma/Academic Research 7
  8. 8. A Different Future… Connect Healthcare and Research … For more efficient use of patient data, to avoid redundant entry and to improve trial performance 80% 72% • 72% of investigational 70% Of Benefit 60% sites consider 50% connecting healthcare 40% and clinical trial 30% 26% 20% systems to be of 10% benefit! 0% 3% Yes No Missing Source: eClinical Forum Site Survey 2009, European data 8
  9. 9. A Different Future… Imagine… Patient Data Exchange Between Healthcare and Drug Development Systems Emerging and Future EHR-Research Connectivity and Complexity Healthcare System Clinical Trial System Integrated Future Current Divided Interoperable Ideal Integrated Future Current Divided • EHRs used to… Interoperable Ideal • EHR systems holding source for data used in • EHR and research systems work clinical trials may not meet essential regulatory • Evaluate Patient Populations seamlessly together so that groups • Accelerate Patient Recruitment requirements benefit from data access and mining • Clinical care data required for clinical trials is capabilities across healthcare and • Capture CT Data entered into EHR and into clinical trial systems research data sets • Research holds source data not part of normal • Research systems and healthcare • Exchange CT Data clinical care systems sit on the same spine • Redundant data entry, transcription errors and • Systems conform to the same data • The EHR becomes the patient data repository source issues cost healthcare and industry exchange standards time and money. 9
  10. 10. 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 Authorities New innovative therapies Higher quality, reliable data Patient available earlier from validated sources Higher quality data provides under investigator control greater safety Lower cost and faster approval of Real-time identification of new therapies safety issues and trends 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 10 …
  11. 11. The Challenge… Healthcare Pharma Research Multiple systems, semantics, ontologies, languages… Various levels of system validation and integration, unstructured information… Need for controlled process for release and transfer of data to meet ethical and data protection requirements… Source data held in EHR may not be appropriate as source for regulated clinical studies … Entry of Patient’s Clinical Data Various standards, levels of system Systems validated & validation and integration, data compliant to Industry & structure depending on country, Regulatory standards & region, institution. Physician / policies e.g. CSUCI, ICH GCP Investigator 11
  12. 12. Why Now… Political, Cultural & Technical Solutions are Starting to Bridge the Gap 1. Political FP7 ICT IMI BRIDG EHRCR Removing obstacles, linking stakeholders and driving the Standards Systems Common data Reliable, need for change standards allow validated movement of Future systems meet 2. Cultural data between healthcare and Connected healthcare and Healthcare & Stakeholders see CR as a special research research Research requirements case for use of EHR data Munich (InferMed: 3. Technical Siemens) Process Controlled process for Projects are developing solutions to APHP/ release and transfer individual components INSERM of data meets bio- ethical requirements The concept has been proven in HANYS single site, technology instances 12
  13. 13. How EHRs Could Enhance CR… Via a standardised, scalable platform that connects healthcare and drug development systems… Standardised interfaces support « Intelligent » computer-readable Extended semantic and ontological multiple data exchange protocols automate querying to directories cover research standards for healthcare and evaluate patient populations, archetypes in multiple languages research data collection, rules etc Platform Patient Population Healthcare Environment Query Pharma Environment HL7 Messages Anonymised Integrated Aggregated Data Extracts Edifact Messages Technology Data Collection Quality Rules and EN13606 Extracts Interoperability CT Patient Data from/to EHR Layer SAE Proprietary Formats Data Exchange 2-way exchange of pseudo- Patients can be connected to Use of standard infrastructure allows anonymised data eliminates clinical trials to improve for multiple CT service providers redundant entry recruitment 13
  14. 14. How EHRs Could Enhance CR… … operating within a sustainable business model Business Model Platform Patient Population Healthcare Environment Query Pharma Environment HL7 Messages Integrated Anonymised Technology Aggregated Data Extracts Edifact Messages and Data Collection Quality Rules Interoperability EN13606 Extracts Layer CT Patient Data from/to EHR SAE Proprietary Formats Qualification of systems, Revenue Data Exchange and cost models Data protection and ethics processes, organisations define value-added and ROI requirements met balance cost and oversight to drive sustainability Organisation Process • Role of Ethics Committees, TTPs etc • Qualification/certification • Governance and oversight • Revenue , investment and cost models • Support infrastructure • Workflow of activities, interfaces, rules 14
  15. 15. Key Messages… 1. The more efficient re-use of EHR data presents opportunities for • Healthcare to reduce redundant data entry • Research to improve clinical trial performance 2. The concept has already been proven in single site and technology pilots 3. There is a political expectation for integration of healthcare and pharma/academic data (FP7 ICT, IMI) 4. The environment is right to actively support and make change happen 15
  16. 16. Key Messages… 5. There are challenges but they can be met by adapting and integrating existing technologies and standards to achieve interoperability 6. A sustainable European business model to facilitate re-use of patient data is needed that meets business, operational, ethical and data protection requirements richard.perkins@con7.com 16
  17. 17. Enabling Clinical Research Through Effective Use Of Patient Data Perspective of the Researcher Richard Perkins President, eClinical Forum

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