real world initiatives: increasing rwe availability across europe
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Real World Initiatives: Increasing RWE availability across Europe
SVMPharma Ltd,Landmark House
Station Road, Hook, Hampshire, UK,
RG27 9HA
CONTACT US [email protected]
+44(0) 1256 962 220www.svmpharma.com
Patient level data access in the NHS: Generating positive
outcomes through Real World Evidence
RWE is already in routine use in the EU but data are often fragmented and
siloed within and across organisations, reducing the visibility and research
potential of datasets.
There are already many national and EU initiatives ongoing to strengthen
RWE. These initiatives are working towards defining common standards
for the content and quality of real world evidence. This includes
addressing incomplete datasets and a lack of quality assurance systems, as
well as generating incentives for data sharing and exploring cross-
stakeholder collaborative approaches.
The main driver behind the development of an EU-level approach to RWD
appears to be the European Commission’s push for the development
of eHealth infrastructures and use of EHRs. Cross-country research
projects are actively supported by different EU programmes to link existing
registries, develop new ones and pool resources, paving the way to more
standardised strategies for the collection and use of RWD.
Systematically collecting patient data through electronic health records
(EHR) has the potential to improve the content of datasets. The OECD
(2013) and the European Commission report that a majority of European
countries are now designing or implementing strategies for the
development of national EHR systems in order to facilitate patient data
collection and the sharing of data amongst primary and secondary care
providers. Some initiatives build on previous developments introduced at
the regional scale (e.g. in the UK, Spain, Belgium or Switzerland) while
others are implementing more centralised strategies (e.g. Sweden,
Austria, France).
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Real World Initiatives
Increasing RWE availability across Europe
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“GetReal aims to show how robust new methods of RWE collectionand synthesis could be developed and considered for adoptionearlier in pharmaceutical R&D and the healthcare decision makingprocess”
Current national eHealth strategy
Pre-implementation of national eHealth strategy
Regional eHealth strategyA strong push towards thedevelopment of electronic healthrecords has been observed in someEuropean countries (Nordiccountries, France, Belgium, the UK)and has been actively supported byvarious EU funding programmes.Such initiatives offer great potentialfor the automated and routinecollection of patient data.
A joint undertaking between the European Union and European Federation of
Pharmaceutical Industries and Associations.
Enhancing pre-launch evidence by focussing on
policy frameworks, understanding drivers of
effectiveness, and pragmatic trial design.
Establishing inter-operable RWE
systems across Europe through EU
funded joint research projects
Since 2004, the EU has been very
active in the internationalisation
and linkage of national and/or
regional databases, although most
of these projects remain focused on
particular diseases or health
conditions.
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A joint EU and Member States response to poor cross-border availability of health data for public health and research
Key issues identified among EU registries:
1. Unstable funding and limited sustainability
2. Legal issues concerning data protection and re-use
3. Roles of different stakeholders are in many cases not clear
4. Modes of data collection 5. Data quality and completeness.
Low awareness of existing standards
PARENT has developedframeworks to assist in
?!
Only 50% of the
registries are currently funded by national
government authority. Around 16% have “no
specific funding” at all.
Around half still
use paper notes
?
User services
PARENT frameworks aim toensure interoperability byregistry holders developingstandardised and shareduser services.
planning, development and implementation of registries to maximise purpose and outputs and promote cross-border enabled registries.
The technology to collect and analysethese huge pools of data exists butthe absence of a commonmethodology still makes it hard toexploit its full potential
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1. eHealth network Recommendations on patients' registries in particular on the use of knowledge gathered through the PARENT Joint Action1. 2016. Available from http://ec.europa.eu/health/ehealth/docs/ev_20151123_co05_en.pdf Accessed October 2016.
2. Zaletel, M., & Kralj, M. et al. Methodological guidelines and recommendations for efficient and rational governance of patient registries. 2015. PARENT.
SVMPharma is an innovative strategic consultancy, specialising in Real WorldEvidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE withinUK and Europe through bespoke online Real World Treatment Evaluators, leading tosuccessful health technology appraisal (HTA) submissions. Clinical trial programmesdo not reflect real-world clinical practice and outcomes, RWE supplements andenhances clinical datasets. SVMPharma’s specialist teams focus on delivering theoutcomes that matter to your brand. SVMPharma also provides Global RWE, PatientReal World Outcomes, and Big Data Analytics.
To find out more call +44 (0) 1256 962 220
The lack of complete datasets, expertise, and common standards canconstitute a barrier to drawing correct conclusions from RWE. Astrong push towards the development of electronic health records –and eHealth infrastructures more broadly – has been observed andcontinues to grow in Europe. EU initiatives actively supported byvarious EU funding programmes offer great potential for theautomated and routine collection of patient data.
SVMPharma is a RWE agency with experience of working on successful HTA resubmissions for NICE and SMC that can help gather
the right RWE data and ease the RWE process to ensure your best chance of gaining positive HTA submissions.
©2016 SVMPharma Ltd. All rights reserved
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
Tel: +44 (0) 1256 962 220
SVMPharma LtdLandmark HouseStation RoadHook, HampshireRG27 9HA
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