Data Governance For UK RWE What Do You Need To Know
SVMPharma Ltd
CONTACT US enquirysvmpharmacom
+44(0) 1252 417030wwwsvmpharmacom
DATA GOVERNANCE FOR UK
REAL WORLD EVIDENCE WHAT
DO YOU NEED TO KNOW
You may not be overly enthused to read an
article about data governance and we
wouldnt blame you After all it sounds
like a dull topic and you can only envisage
the inevitable additional paperwork
But donrsquot go anywhere hear us out on this
one
Data governance for Real World Evidence
(RWE) clinical data collected outside of a
conventional randomised controlled trial
is a different beast to what you know and
expect from traditional clinical trials
Although many areas overlap there are a
number of important concepts and
principles that set it apart
Data governance for RWE is a wide-ranging
topic here we distil it down into 3 parts In
Part A we will briefly introduce data
governance and consider what it is Part B
will go into the types of RWE data available
in the UK in relation to data governance
arrangements Finally Part C will provide an
overview of the key aspects you need to
consider for good RWE data governance
PART A
A BRIEF INTRODUCTION TO DATA
GOVERNANCE
So what is data governance Unfortunately
the term does not come with a straight-
forward definition For example as defined
by the Data Governance Institute [1] data
governance is lsquoa system of decision rights
and accountabilities for information-related
processes executed according to agreed-
upon models which describe who can take
what actions with what information and
when under what circumstances using
what methodsrsquo Isnrsquot that quite a mouthful
Several other definitions exist [1] and serve to
underline that data governance is an all-
encompassing subject that impacts upon
every stage data collection and
management Luckily as you will see in Part
C we can break it down into its constituent
elements and principles to make it much
more palatable
If you have worked with healthcare data you
may be more familiar with information
governance (IG) What is the difference
The truth is that many organisations use the
terms interchangeably although there have
been moves to separate them [2] In theory
information = data + context so whilst data
governance should focus on issues such as
data quality and data security IG would be
more concerned with appropriate use and
information lifecycle [2]
Whichever way you define it what is clear is
that data governance is important and plays
a central role in shaping all stages of data
collection management and sharing
Lets look at how data governance will impact
and shape your RWE project
2 copy2016 SVMPharma Ltd All rights reserved
wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
PART B
REAL WORLD EVIDENCE DE NOVO DATA
COLLECTION VS ROUTINELY COLLECTED
DATASETS
RWE is clinical data collected outside ofconventional randomised controlled trialsRWE covers a broad group of data collectionmethods including existing large datasetsnon-interventional studies audits and muchmore Nevertheless whatever themethodology used a RWE project is going toinvolve either de novo data collection or useof a routinely collected dataset
As you may be aware data governancepolicies vary country-to-country and this willshape what options are available to youHere we are focussing on the UK which wecan demonstrate to be an excellent place forRWE data collection
DE NOVO DATA COLLECTION IN THE UK IS
YOUR RWE PROJECT RESEARCH
When it comes to de novo data collection akey advantage of RWE in the UK is option totake the service evaluation route instead ofthe traditional research route
In the UK clinical data collectionprogrammes can be classed as researchaudit or service evaluation Researchprogrammes derive generalisable newknowledge and generate and testhypotheses An audit is designed andconducted to produce information to informdelivery of best care An audit asks lsquoDoes thisservice reach a pre-determined standardrsquoOn the other hand a service evaluationprogramme considers a servicersquoseffectiveness or efficiency through
systematic assessment of its aimsobjectives activities outputs outcomes andcosts This approach can be used to comparea new treatment or service with an existingone but cannot be used for measurementagainst standards [3]
Service evaluation generates evidence of theeffectiveness of a service which may lead toservice redesign and is fully endorsed by theNHS Such projects do not require ethicalreview by a NHS or Social Care ResearchEthics Committee or managementpermission through the NHS RampD office [4]
Unlike clinical research this approach doesnot allow generalisability of the result butthe aims of the project the selection of thecentres and the parameters of the datacollection can be adapted to ensure that theconclusions are clear and persuasive Denovo RWE data collection through serviceevaluation represents a time- and cost-effective route for collecting RWE in the UK
3wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
ROUTINELY COLLECTED DATASETS IN THE
UK WHAT IS AVAILABLE
The UK has a global reputation for high-quality complete datasets of routinelycollected data However the devolvednations in the UK each have their ownorganisations processes and regulationswhich may initially seem daunting Here arethe key points you need to know if you arelooking to collect RWE by this route
In England The Health and Social CareInformation Centre (HSCIC) is the nationalprovider of information and data for healthand social care A key resource held by theHSCIC is the Hospital Episode Statistics (HES)dataset which contains over 1 billionrecords of patient attending Accident andEmergency units outpatient clinics and NHShospitals in England HES is a records-basedsystem which was designed for secondaryuse HES data is comprehensive as hospitalpayments are based on the informationsubmitted to HES
The Clinical Practice Research Datalink(CPRD) collects and hosts anonymisedprimary care data from a proportion ofGeneral Practices (GPs) in the UK coveringpatient registration information and all careevents that GPs record as part of usualmedical practice (eg including diagnosesreferrals prescriptions lifestyle informationetc)
Unfortunately there is no central NHScollation of information on medicines issuedand used in NHS hospitals This data isavailable from a major private organisationas part of the Hospital Pharmacy Audit Index(HPAI) covering 99 of all drugs prescribedin hospitals Also of note there are a
number of specialist datasets in England(eg oncology data collected in CancerOutcomes and Services Dataset (COSD) aswell as the Systemic Anti-Cancer TherapyDataset (SACT)
In Wales a central access point for routinely-collected national health data is the SecureAnonymised Information Linkage databank(SAIL) In Scotland the electronic DataResearch and Innovation Service (eDRIS)provides a single entry point for researchapprovals and data access to Scottish healthdata that is routinely collected Finally inNorthern Ireland Health and Social CareNorthern Ireland (HSCNI) is the informationhub for health services [4]
Specific data governance arrangements andaccess costs requirements are particular toeach organisation but the volume andbreadth of the data available across the UKare noteworthy
4wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
Part C
A POTENTIAL FRAMEWORK FOR RWE DATA
GOVERNANCE
Now that we have a good idea of the typesof data you may be working with we needto look at the key principles of datagovernance with respect to RWE One wayto approach this is to break it down into 4stages
RAW REAL WORLD EVIDENCE DATA
Whether you have raw data from de novoRWE data collection or from routinelycollected datasets will determine the formatof the data and how it is structured To meetgood data governance for raw RWE data youneed to consider data protection legislationThis will involve establishing legitimising andexplicitly stating the purpose for collectingthe data As the purpose is likely beyond thedirect care of the patient is data collectionneeded for evaluation assessment researchand is there a public interest Data qualityassurance is needed you need to ensurethat the records are accurate and up-to-date
Patient consent is a vital issue to address atthis stage where patient consent is notfeasible the collection of data for purposesbeyond direct care can be supported withrelevant legislation (there must be
substantial benefit to collecting andprocessing the data) Where appropriatethere must be clear communication to datasubjects of potential future uses of theirdata
You need to strike a balance between privacyrisks and the public benefit and justify yourreasoning Furthermore it is essential toestablish lsquoownershiprsquo of the data who willtake responsibility Will it be the partycollecting the data the sponsor or thecentre where the data is collected Beingclear and transparent at this stage andthinking ahead will establish solidfoundations for the rest of the project [4]
CLEANING MANAGING RWE DATA
RWE data cleaning and management canmore complex than what you are used to inclinical trials After all data in the real-worldis more diverse and inconsistent than whatyou would expect in a RCT At this stagegood data governance should involve de-identification of the data where appropriatePseudonymisation can be designed at thepoint of data collection itself but if that isnot possible then it should be addressed atthis stage You also have a responsibility toensure that the quality and integrity of thedata is maintained
You should address security arrangementswhich could include technical computingprotections or confidentiality training forrelevant staff One question to bear in mindis how long data should be kept Dataprotection legislation refers to lsquono longerthan necessaryrsquo and the answer to this maydepend on the study design itself eg inlong-term longitudinal studies [4]
5wwwsvmpharmacom
RAW RWE DATA
CLEANING MANAGING RWE DATA
LINKING AGGREGATION OF RWE DATA
ACCESS USE OF RWE DATA
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
DATA GOVERNANCE FOR UK
REAL WORLD EVIDENCE WHAT
DO YOU NEED TO KNOW
You may not be overly enthused to read an
article about data governance and we
wouldnt blame you After all it sounds
like a dull topic and you can only envisage
the inevitable additional paperwork
But donrsquot go anywhere hear us out on this
one
Data governance for Real World Evidence
(RWE) clinical data collected outside of a
conventional randomised controlled trial
is a different beast to what you know and
expect from traditional clinical trials
Although many areas overlap there are a
number of important concepts and
principles that set it apart
Data governance for RWE is a wide-ranging
topic here we distil it down into 3 parts In
Part A we will briefly introduce data
governance and consider what it is Part B
will go into the types of RWE data available
in the UK in relation to data governance
arrangements Finally Part C will provide an
overview of the key aspects you need to
consider for good RWE data governance
PART A
A BRIEF INTRODUCTION TO DATA
GOVERNANCE
So what is data governance Unfortunately
the term does not come with a straight-
forward definition For example as defined
by the Data Governance Institute [1] data
governance is lsquoa system of decision rights
and accountabilities for information-related
processes executed according to agreed-
upon models which describe who can take
what actions with what information and
when under what circumstances using
what methodsrsquo Isnrsquot that quite a mouthful
Several other definitions exist [1] and serve to
underline that data governance is an all-
encompassing subject that impacts upon
every stage data collection and
management Luckily as you will see in Part
C we can break it down into its constituent
elements and principles to make it much
more palatable
If you have worked with healthcare data you
may be more familiar with information
governance (IG) What is the difference
The truth is that many organisations use the
terms interchangeably although there have
been moves to separate them [2] In theory
information = data + context so whilst data
governance should focus on issues such as
data quality and data security IG would be
more concerned with appropriate use and
information lifecycle [2]
Whichever way you define it what is clear is
that data governance is important and plays
a central role in shaping all stages of data
collection management and sharing
Lets look at how data governance will impact
and shape your RWE project
2 copy2016 SVMPharma Ltd All rights reserved
wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
PART B
REAL WORLD EVIDENCE DE NOVO DATA
COLLECTION VS ROUTINELY COLLECTED
DATASETS
RWE is clinical data collected outside ofconventional randomised controlled trialsRWE covers a broad group of data collectionmethods including existing large datasetsnon-interventional studies audits and muchmore Nevertheless whatever themethodology used a RWE project is going toinvolve either de novo data collection or useof a routinely collected dataset
As you may be aware data governancepolicies vary country-to-country and this willshape what options are available to youHere we are focussing on the UK which wecan demonstrate to be an excellent place forRWE data collection
DE NOVO DATA COLLECTION IN THE UK IS
YOUR RWE PROJECT RESEARCH
When it comes to de novo data collection akey advantage of RWE in the UK is option totake the service evaluation route instead ofthe traditional research route
In the UK clinical data collectionprogrammes can be classed as researchaudit or service evaluation Researchprogrammes derive generalisable newknowledge and generate and testhypotheses An audit is designed andconducted to produce information to informdelivery of best care An audit asks lsquoDoes thisservice reach a pre-determined standardrsquoOn the other hand a service evaluationprogramme considers a servicersquoseffectiveness or efficiency through
systematic assessment of its aimsobjectives activities outputs outcomes andcosts This approach can be used to comparea new treatment or service with an existingone but cannot be used for measurementagainst standards [3]
Service evaluation generates evidence of theeffectiveness of a service which may lead toservice redesign and is fully endorsed by theNHS Such projects do not require ethicalreview by a NHS or Social Care ResearchEthics Committee or managementpermission through the NHS RampD office [4]
Unlike clinical research this approach doesnot allow generalisability of the result butthe aims of the project the selection of thecentres and the parameters of the datacollection can be adapted to ensure that theconclusions are clear and persuasive Denovo RWE data collection through serviceevaluation represents a time- and cost-effective route for collecting RWE in the UK
3wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
ROUTINELY COLLECTED DATASETS IN THE
UK WHAT IS AVAILABLE
The UK has a global reputation for high-quality complete datasets of routinelycollected data However the devolvednations in the UK each have their ownorganisations processes and regulationswhich may initially seem daunting Here arethe key points you need to know if you arelooking to collect RWE by this route
In England The Health and Social CareInformation Centre (HSCIC) is the nationalprovider of information and data for healthand social care A key resource held by theHSCIC is the Hospital Episode Statistics (HES)dataset which contains over 1 billionrecords of patient attending Accident andEmergency units outpatient clinics and NHShospitals in England HES is a records-basedsystem which was designed for secondaryuse HES data is comprehensive as hospitalpayments are based on the informationsubmitted to HES
The Clinical Practice Research Datalink(CPRD) collects and hosts anonymisedprimary care data from a proportion ofGeneral Practices (GPs) in the UK coveringpatient registration information and all careevents that GPs record as part of usualmedical practice (eg including diagnosesreferrals prescriptions lifestyle informationetc)
Unfortunately there is no central NHScollation of information on medicines issuedand used in NHS hospitals This data isavailable from a major private organisationas part of the Hospital Pharmacy Audit Index(HPAI) covering 99 of all drugs prescribedin hospitals Also of note there are a
number of specialist datasets in England(eg oncology data collected in CancerOutcomes and Services Dataset (COSD) aswell as the Systemic Anti-Cancer TherapyDataset (SACT)
In Wales a central access point for routinely-collected national health data is the SecureAnonymised Information Linkage databank(SAIL) In Scotland the electronic DataResearch and Innovation Service (eDRIS)provides a single entry point for researchapprovals and data access to Scottish healthdata that is routinely collected Finally inNorthern Ireland Health and Social CareNorthern Ireland (HSCNI) is the informationhub for health services [4]
Specific data governance arrangements andaccess costs requirements are particular toeach organisation but the volume andbreadth of the data available across the UKare noteworthy
4wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
Part C
A POTENTIAL FRAMEWORK FOR RWE DATA
GOVERNANCE
Now that we have a good idea of the typesof data you may be working with we needto look at the key principles of datagovernance with respect to RWE One wayto approach this is to break it down into 4stages
RAW REAL WORLD EVIDENCE DATA
Whether you have raw data from de novoRWE data collection or from routinelycollected datasets will determine the formatof the data and how it is structured To meetgood data governance for raw RWE data youneed to consider data protection legislationThis will involve establishing legitimising andexplicitly stating the purpose for collectingthe data As the purpose is likely beyond thedirect care of the patient is data collectionneeded for evaluation assessment researchand is there a public interest Data qualityassurance is needed you need to ensurethat the records are accurate and up-to-date
Patient consent is a vital issue to address atthis stage where patient consent is notfeasible the collection of data for purposesbeyond direct care can be supported withrelevant legislation (there must be
substantial benefit to collecting andprocessing the data) Where appropriatethere must be clear communication to datasubjects of potential future uses of theirdata
You need to strike a balance between privacyrisks and the public benefit and justify yourreasoning Furthermore it is essential toestablish lsquoownershiprsquo of the data who willtake responsibility Will it be the partycollecting the data the sponsor or thecentre where the data is collected Beingclear and transparent at this stage andthinking ahead will establish solidfoundations for the rest of the project [4]
CLEANING MANAGING RWE DATA
RWE data cleaning and management canmore complex than what you are used to inclinical trials After all data in the real-worldis more diverse and inconsistent than whatyou would expect in a RCT At this stagegood data governance should involve de-identification of the data where appropriatePseudonymisation can be designed at thepoint of data collection itself but if that isnot possible then it should be addressed atthis stage You also have a responsibility toensure that the quality and integrity of thedata is maintained
You should address security arrangementswhich could include technical computingprotections or confidentiality training forrelevant staff One question to bear in mindis how long data should be kept Dataprotection legislation refers to lsquono longerthan necessaryrsquo and the answer to this maydepend on the study design itself eg inlong-term longitudinal studies [4]
5wwwsvmpharmacom
RAW RWE DATA
CLEANING MANAGING RWE DATA
LINKING AGGREGATION OF RWE DATA
ACCESS USE OF RWE DATA
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
copy2016 SVMPharma Ltd All rights reserved
PART B
REAL WORLD EVIDENCE DE NOVO DATA
COLLECTION VS ROUTINELY COLLECTED
DATASETS
RWE is clinical data collected outside ofconventional randomised controlled trialsRWE covers a broad group of data collectionmethods including existing large datasetsnon-interventional studies audits and muchmore Nevertheless whatever themethodology used a RWE project is going toinvolve either de novo data collection or useof a routinely collected dataset
As you may be aware data governancepolicies vary country-to-country and this willshape what options are available to youHere we are focussing on the UK which wecan demonstrate to be an excellent place forRWE data collection
DE NOVO DATA COLLECTION IN THE UK IS
YOUR RWE PROJECT RESEARCH
When it comes to de novo data collection akey advantage of RWE in the UK is option totake the service evaluation route instead ofthe traditional research route
In the UK clinical data collectionprogrammes can be classed as researchaudit or service evaluation Researchprogrammes derive generalisable newknowledge and generate and testhypotheses An audit is designed andconducted to produce information to informdelivery of best care An audit asks lsquoDoes thisservice reach a pre-determined standardrsquoOn the other hand a service evaluationprogramme considers a servicersquoseffectiveness or efficiency through
systematic assessment of its aimsobjectives activities outputs outcomes andcosts This approach can be used to comparea new treatment or service with an existingone but cannot be used for measurementagainst standards [3]
Service evaluation generates evidence of theeffectiveness of a service which may lead toservice redesign and is fully endorsed by theNHS Such projects do not require ethicalreview by a NHS or Social Care ResearchEthics Committee or managementpermission through the NHS RampD office [4]
Unlike clinical research this approach doesnot allow generalisability of the result butthe aims of the project the selection of thecentres and the parameters of the datacollection can be adapted to ensure that theconclusions are clear and persuasive Denovo RWE data collection through serviceevaluation represents a time- and cost-effective route for collecting RWE in the UK
3wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
ROUTINELY COLLECTED DATASETS IN THE
UK WHAT IS AVAILABLE
The UK has a global reputation for high-quality complete datasets of routinelycollected data However the devolvednations in the UK each have their ownorganisations processes and regulationswhich may initially seem daunting Here arethe key points you need to know if you arelooking to collect RWE by this route
In England The Health and Social CareInformation Centre (HSCIC) is the nationalprovider of information and data for healthand social care A key resource held by theHSCIC is the Hospital Episode Statistics (HES)dataset which contains over 1 billionrecords of patient attending Accident andEmergency units outpatient clinics and NHShospitals in England HES is a records-basedsystem which was designed for secondaryuse HES data is comprehensive as hospitalpayments are based on the informationsubmitted to HES
The Clinical Practice Research Datalink(CPRD) collects and hosts anonymisedprimary care data from a proportion ofGeneral Practices (GPs) in the UK coveringpatient registration information and all careevents that GPs record as part of usualmedical practice (eg including diagnosesreferrals prescriptions lifestyle informationetc)
Unfortunately there is no central NHScollation of information on medicines issuedand used in NHS hospitals This data isavailable from a major private organisationas part of the Hospital Pharmacy Audit Index(HPAI) covering 99 of all drugs prescribedin hospitals Also of note there are a
number of specialist datasets in England(eg oncology data collected in CancerOutcomes and Services Dataset (COSD) aswell as the Systemic Anti-Cancer TherapyDataset (SACT)
In Wales a central access point for routinely-collected national health data is the SecureAnonymised Information Linkage databank(SAIL) In Scotland the electronic DataResearch and Innovation Service (eDRIS)provides a single entry point for researchapprovals and data access to Scottish healthdata that is routinely collected Finally inNorthern Ireland Health and Social CareNorthern Ireland (HSCNI) is the informationhub for health services [4]
Specific data governance arrangements andaccess costs requirements are particular toeach organisation but the volume andbreadth of the data available across the UKare noteworthy
4wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
Part C
A POTENTIAL FRAMEWORK FOR RWE DATA
GOVERNANCE
Now that we have a good idea of the typesof data you may be working with we needto look at the key principles of datagovernance with respect to RWE One wayto approach this is to break it down into 4stages
RAW REAL WORLD EVIDENCE DATA
Whether you have raw data from de novoRWE data collection or from routinelycollected datasets will determine the formatof the data and how it is structured To meetgood data governance for raw RWE data youneed to consider data protection legislationThis will involve establishing legitimising andexplicitly stating the purpose for collectingthe data As the purpose is likely beyond thedirect care of the patient is data collectionneeded for evaluation assessment researchand is there a public interest Data qualityassurance is needed you need to ensurethat the records are accurate and up-to-date
Patient consent is a vital issue to address atthis stage where patient consent is notfeasible the collection of data for purposesbeyond direct care can be supported withrelevant legislation (there must be
substantial benefit to collecting andprocessing the data) Where appropriatethere must be clear communication to datasubjects of potential future uses of theirdata
You need to strike a balance between privacyrisks and the public benefit and justify yourreasoning Furthermore it is essential toestablish lsquoownershiprsquo of the data who willtake responsibility Will it be the partycollecting the data the sponsor or thecentre where the data is collected Beingclear and transparent at this stage andthinking ahead will establish solidfoundations for the rest of the project [4]
CLEANING MANAGING RWE DATA
RWE data cleaning and management canmore complex than what you are used to inclinical trials After all data in the real-worldis more diverse and inconsistent than whatyou would expect in a RCT At this stagegood data governance should involve de-identification of the data where appropriatePseudonymisation can be designed at thepoint of data collection itself but if that isnot possible then it should be addressed atthis stage You also have a responsibility toensure that the quality and integrity of thedata is maintained
You should address security arrangementswhich could include technical computingprotections or confidentiality training forrelevant staff One question to bear in mindis how long data should be kept Dataprotection legislation refers to lsquono longerthan necessaryrsquo and the answer to this maydepend on the study design itself eg inlong-term longitudinal studies [4]
5wwwsvmpharmacom
RAW RWE DATA
CLEANING MANAGING RWE DATA
LINKING AGGREGATION OF RWE DATA
ACCESS USE OF RWE DATA
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
copy2016 SVMPharma Ltd All rights reserved
ROUTINELY COLLECTED DATASETS IN THE
UK WHAT IS AVAILABLE
The UK has a global reputation for high-quality complete datasets of routinelycollected data However the devolvednations in the UK each have their ownorganisations processes and regulationswhich may initially seem daunting Here arethe key points you need to know if you arelooking to collect RWE by this route
In England The Health and Social CareInformation Centre (HSCIC) is the nationalprovider of information and data for healthand social care A key resource held by theHSCIC is the Hospital Episode Statistics (HES)dataset which contains over 1 billionrecords of patient attending Accident andEmergency units outpatient clinics and NHShospitals in England HES is a records-basedsystem which was designed for secondaryuse HES data is comprehensive as hospitalpayments are based on the informationsubmitted to HES
The Clinical Practice Research Datalink(CPRD) collects and hosts anonymisedprimary care data from a proportion ofGeneral Practices (GPs) in the UK coveringpatient registration information and all careevents that GPs record as part of usualmedical practice (eg including diagnosesreferrals prescriptions lifestyle informationetc)
Unfortunately there is no central NHScollation of information on medicines issuedand used in NHS hospitals This data isavailable from a major private organisationas part of the Hospital Pharmacy Audit Index(HPAI) covering 99 of all drugs prescribedin hospitals Also of note there are a
number of specialist datasets in England(eg oncology data collected in CancerOutcomes and Services Dataset (COSD) aswell as the Systemic Anti-Cancer TherapyDataset (SACT)
In Wales a central access point for routinely-collected national health data is the SecureAnonymised Information Linkage databank(SAIL) In Scotland the electronic DataResearch and Innovation Service (eDRIS)provides a single entry point for researchapprovals and data access to Scottish healthdata that is routinely collected Finally inNorthern Ireland Health and Social CareNorthern Ireland (HSCNI) is the informationhub for health services [4]
Specific data governance arrangements andaccess costs requirements are particular toeach organisation but the volume andbreadth of the data available across the UKare noteworthy
4wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
Part C
A POTENTIAL FRAMEWORK FOR RWE DATA
GOVERNANCE
Now that we have a good idea of the typesof data you may be working with we needto look at the key principles of datagovernance with respect to RWE One wayto approach this is to break it down into 4stages
RAW REAL WORLD EVIDENCE DATA
Whether you have raw data from de novoRWE data collection or from routinelycollected datasets will determine the formatof the data and how it is structured To meetgood data governance for raw RWE data youneed to consider data protection legislationThis will involve establishing legitimising andexplicitly stating the purpose for collectingthe data As the purpose is likely beyond thedirect care of the patient is data collectionneeded for evaluation assessment researchand is there a public interest Data qualityassurance is needed you need to ensurethat the records are accurate and up-to-date
Patient consent is a vital issue to address atthis stage where patient consent is notfeasible the collection of data for purposesbeyond direct care can be supported withrelevant legislation (there must be
substantial benefit to collecting andprocessing the data) Where appropriatethere must be clear communication to datasubjects of potential future uses of theirdata
You need to strike a balance between privacyrisks and the public benefit and justify yourreasoning Furthermore it is essential toestablish lsquoownershiprsquo of the data who willtake responsibility Will it be the partycollecting the data the sponsor or thecentre where the data is collected Beingclear and transparent at this stage andthinking ahead will establish solidfoundations for the rest of the project [4]
CLEANING MANAGING RWE DATA
RWE data cleaning and management canmore complex than what you are used to inclinical trials After all data in the real-worldis more diverse and inconsistent than whatyou would expect in a RCT At this stagegood data governance should involve de-identification of the data where appropriatePseudonymisation can be designed at thepoint of data collection itself but if that isnot possible then it should be addressed atthis stage You also have a responsibility toensure that the quality and integrity of thedata is maintained
You should address security arrangementswhich could include technical computingprotections or confidentiality training forrelevant staff One question to bear in mindis how long data should be kept Dataprotection legislation refers to lsquono longerthan necessaryrsquo and the answer to this maydepend on the study design itself eg inlong-term longitudinal studies [4]
5wwwsvmpharmacom
RAW RWE DATA
CLEANING MANAGING RWE DATA
LINKING AGGREGATION OF RWE DATA
ACCESS USE OF RWE DATA
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
copy2016 SVMPharma Ltd All rights reserved
Part C
A POTENTIAL FRAMEWORK FOR RWE DATA
GOVERNANCE
Now that we have a good idea of the typesof data you may be working with we needto look at the key principles of datagovernance with respect to RWE One wayto approach this is to break it down into 4stages
RAW REAL WORLD EVIDENCE DATA
Whether you have raw data from de novoRWE data collection or from routinelycollected datasets will determine the formatof the data and how it is structured To meetgood data governance for raw RWE data youneed to consider data protection legislationThis will involve establishing legitimising andexplicitly stating the purpose for collectingthe data As the purpose is likely beyond thedirect care of the patient is data collectionneeded for evaluation assessment researchand is there a public interest Data qualityassurance is needed you need to ensurethat the records are accurate and up-to-date
Patient consent is a vital issue to address atthis stage where patient consent is notfeasible the collection of data for purposesbeyond direct care can be supported withrelevant legislation (there must be
substantial benefit to collecting andprocessing the data) Where appropriatethere must be clear communication to datasubjects of potential future uses of theirdata
You need to strike a balance between privacyrisks and the public benefit and justify yourreasoning Furthermore it is essential toestablish lsquoownershiprsquo of the data who willtake responsibility Will it be the partycollecting the data the sponsor or thecentre where the data is collected Beingclear and transparent at this stage andthinking ahead will establish solidfoundations for the rest of the project [4]
CLEANING MANAGING RWE DATA
RWE data cleaning and management canmore complex than what you are used to inclinical trials After all data in the real-worldis more diverse and inconsistent than whatyou would expect in a RCT At this stagegood data governance should involve de-identification of the data where appropriatePseudonymisation can be designed at thepoint of data collection itself but if that isnot possible then it should be addressed atthis stage You also have a responsibility toensure that the quality and integrity of thedata is maintained
You should address security arrangementswhich could include technical computingprotections or confidentiality training forrelevant staff One question to bear in mindis how long data should be kept Dataprotection legislation refers to lsquono longerthan necessaryrsquo and the answer to this maydepend on the study design itself eg inlong-term longitudinal studies [4]
5wwwsvmpharmacom
RAW RWE DATA
CLEANING MANAGING RWE DATA
LINKING AGGREGATION OF RWE DATA
ACCESS USE OF RWE DATA
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
copy2016 SVMPharma Ltd All rights reserved
LINKING AGGREGATION OF RWE DATA
Linking data across datasets can be animportant part of your project andpseudonymised IDs for the data plays animportant role However data linkage raisesthe risk of re-identification of data Youneed to consider if the distinct datasets havetheir own governance requirements andpolicies and how you can manage thisAgreeing consistent and compatible ruleswill optimise interoperability of differentdatasets You can consider if data linkagecan be undertaken by a trusted third partyAdditionally remember data can be madecompletely anonymous via sharing aggregatedata [4]
ACCESS USE OF RWE DATA
Access and use of the RWE data shouldmatch the purpose of RWE data collectiondiscussed at the initial stage You mustconsider whether you have the in-housecapacity for analyses modelling and howyou can safely share the data for externalprocessing if required Permission for dataaccess should be granted with contractualrequirements around the protection ofconfidentiality The agreement should clearlydefine the scope and define duration of useThere are a number of methods of allowinglimited and controlled access to the data(eg patient-level data provided toresearchers in a physical space use ofdistributed network common dataframework consortium with uniform coding)[4]
Finally a couple of additional points toreview at this stage is the affiliation of thedata user and access costs The motives ofthe user given access to the data caninfluence the risk of distribution and
safeguards should be in place If applicableaccess costs should be fair and notexcessive [4]
6wwwsvmpharmacom
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
copy2016 SVMPharma Ltd All rights reserved
1Thomas G Defining Data Governance The Data Governance Institute 2015 Available at httpwwwdatagovernancecomdefining-data-governance Accessed Feb 2016
2 Schmidt J Information Governance vs Data Governance ndash Who Cares Informatica Corporation 2014Available at httpblogsinformaticacom20140903information-governance-vs-data-governance-who-cares Accessed Feb 2016
3 Health Research Authority (HRA) Defining Research 2013 Available at httpwwwhranhsukdocuments201309defining-researchpdf Accessed Feb 2016
4 Office of Health Economics (OHE) Data Governance Arrangements for RWE 2015 Available at httpswwwoheorgpublicationsdata-governance-arrangements-real-world-evidence Accessed Feb 2016
Cover Photo Designed by sxc - Freepikcom
If you have made it this far you will have hopefully picked up the essential of data governancefor RWE Data governance is a vast topic and one that is dynamic and subject to continualchange Refreshing your understanding of data governance and updating with newdevelopments is important to ensure you are on the right track and to help your RWE projectsucceed
The UK has much to offer when it comes to RWE data collection Whether it be theretrospective case reviews route for de novo RWE data collection or the variety of routinelycollected datasets available there are considerable possibilities available To take advantageof this you need to understand the basics of data governance in relation to RWE
Utilising a framework for data governance and ensuring you address each of the key areaswill benefit both the RWE project itself and demonstrate good governance to clientsregulatory bodies and other stakeholders
7wwwsvmpharmacom
SVMPharma is an innovative strategic consultancy specialising in Real World Evidence (RWE) forthe pharmaceutical industry SVMPharma generates RWE within UK and Europe through bespokeonline Real World Treatment Evaluators leading to successful health technology appraisal (HTA)submissions Clinical trial programmes do not reflect real-world clinical practice and outcomesRWE supplements and enhances clinical datasets SVMPharmarsquos specialist teams focus ondelivering the outcomes 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
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquirysvmpharmacom
Tel +44 (0) 1252 417030
SVMPharma Ltd
Visit svmpharmacom
Follow svmpharma
Follow on Google+
Connect via LinkedIn
Get In Touch