Transcript KHeidenReich_Industry`s view - presentation KH finalx

Primary and secondary use of EHR:
Enhancing clinical research
Pharmaceutical Industry
Perspectives
Dr. Karin Heidenreich
Senior Public Affairs Manager/Novartis
Brussels, 11th October 2007
Agenda
 Opportunities for the pharmaceutical industry
 Potential risks
 Questions to be solved
 Possible solutions
 Conclusion
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Background
EHR
 are primarily being created to improve healthcare for
individual patients
 are sensitive data, therefore their use need informed consent
and measures to protect privacy and identity
 provide comprehensive health information on a large number
of people
 offer a potential for the generation of important knowledge for
the benefit of patients and society
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Opportunities for the pharmaceutical industry
- in Epidemiology
 Potential to use a broad spectrum of “real life” health
information for
 Epidemiological studies
 Identification of medical need and rare diseases
 Orphan drug designations
 Market size estimations
 Disease prioritization
 Establishment of disease registries

Useful for strategic planning in the health sector
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Opportunities for the pharmaceutical industry
- for Pharmacovigilance
Critical for improving the Pharmacovigilance reporting system
(similar to FDA-industry consortium in USA)
 Allow for systematic detection of medical events, thereby avoiding
huge under-reporting
 Early detection of new safety signals linked with drug intake
 Analyses of interactions between different simultaneously
administered medication
 Understanding of risk factors that lead to major averse reactions
 Development of a safety reporting system via EHR
 Via a project within the Innovative Medicines Initiative in the
workstream “predictive drug safety“
 Improvement of safety assessment and better labeling
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Opportunities for the pharmaceutical industry
- in Clinical Trials Settings
Data from EHR could
 help to check protocol feasibility, with the potential
consequence to change inclusion/exclusion criteria
 Avoidance of amendments
 help to identify investigators and clinical trial centers
 Better planning of patient recruitment rates and drug supply
 be used as source data from which relevant data are
transferred to CRFs
 Reduce data errors, resources, time, paper…
More efficient clinical trials for a faster development of
medicinal products
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Opportunities for the pharmaceutical industry
- others
 Analyses of medication utilization patterns and the potential
impact of utilization on outcomes
 EHR data could be used as historical controls
 For clinical trials as well as for health economic
assessments
 Validation of models
 …
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Potential risks
 Related to legal, privacy as well as regulatory
issues
 EHR are data collected for individual health care
and not as tool for researchers (or other interested
parties)
 Access of non-authorised parties to EHR via
hacking
 Data quality
 Regulatory acceptability
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Potential risks
- legal/privacy point of view
 EHR are data collected for created for individual health care
and not as tool for researchers (or other interested parties)
 Access to these sensitive data may lead to anxiety that
patients are considered a “transparent patient” (even if data are
“anonymised”, e.g. in case of rare diseases patients may easily be
traced back)
 Uncertainty where these data end up and what is done with
them
 Access of non-authorised parties to EHR via hacking
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Potential risks
- regulatory point of view
 Data quality may be low
 Incorrect - since the capture of these data are not controlled
and verified according to GCP
 Incomplete – since they were collected for other purposes
 Big amount of data with high variability
 Regulatory acceptability questionable due to mixed quality of
data
 Results from such analyses can only be supportive in
registration procedures
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Prerequisites
- Industry standpoints & principles
Secondary use of EHR should be guided by following principles:
 Proper management of pseudonymised, anonymised, and
aggregated information
 Management of patient consent
 Governance arrangements of security & confidentiality of data
 Supporting cultural and good practice issues
 Transparency and openness
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Questions to be solved
 What data shall be in EHR? What about inclusion of genomic
data?
 Should industry have direct access to EHR? If so, to all
available information?
 Or access to EHR data via a 3rd party? Who is the 3rd party?
Can it be a commercial entity?
 How to manage informed consent with patients?
 Shall patients have reading and editing rights for EHR?
 Who owns the data in EHR and the derived analyses?
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Proposals for possible solutions
- relating to privacy issues
 Give researchers/industry access to EHR data via noncommercial 3rd parties.
 3rd party
 May be responsible to secure data privacy (via
“anonymisation”)
 May be responsible to obtain informed consent (via contact
with doctors if necessary)
 Could play the role of a broker, i.e. run searches &
investigations on specific requests and get paid for that
 Establish system for secure access to data
 Via electronic signatures, passwords, data encryption etc.
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Proposals for possible solutions
- relating to data quality
 Promote uniform standards for collecting data for EHR
across Europe and quality assurance
 Systems need to be validated to ensure high quality
 Link different systems in Europe
 To prevent illegal data hacking: virtual health records, which
build themselves up (“on the fly”) in the system as soon as
they are requested
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Summary
 Huge potential for medical research and safety surveillance
via use of EHR data
 Learn more about epidemiology of diseases
 Save time and resources for faster development of
medicines
 Improvement of current pharmacovigilance system
 There are lots of questions, but also many possible solutions
 Industry is fully aware of the sensitivity of the use of patients’
health data and its responsibility in this field
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Conclusion
 Primary and secondary use of EHR matters all
 We need a thorough public debate with all
stakeholders
 We need to find constructive proposals for the safe
use of EHR
 Industry should agree on a codex on how to deal
with these sensitive data
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THANK YOU
For attention and your questions.
For input to this presentation from the EFPIA EHR Task
Force and my colleagues with Novartis.