Electronic Health Records for Clinical Research

OPTIMISING CLINICAL RESEARCH PROCESSES: THE RESULTS OF EHR4CR

Dipak Kalra President of i~HD

Mats Sundgren AstraZeneca EMIF conference:

E-managing the Future of Health Data

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Patient recruitment a major cause of trial delays ▪  With no searchable patient database, identifying and recruiting suitable patients and trial sites are principal

causes of trial delays

▪  Delayed trials waste costly resources and slow access to new drugs

50%    of  today’s  clinical  trials  fail  to  achieve  the  target  recruitment  rate4    

Almost    

half  of  all  trial  delays  caused  by  pa<ent  recruitment  problems2      

1.  State  of  the  Clinical  Trials  Industry:  A  Sourcebook  of  Charts  and  Sta<s<cs,  Center  Watch,  2008.  2.  Study  Par<cipant  Recruitment  and  Reten<on  in  Clinical  Trials:  Emerging  strategies  in  Europe,  the  US  and  Asia,  Business  Insights,  June  2007.  3.  Beasley,  “Recrui<ng”  2008  4.  TuOs  -­‐hQp://clinicalperformancepartners.com/wp-­‐content/uploads/2012/07/Fixing-­‐Feasibility-­‐Final-­‐Jan-­‐2012.pdf      

Each  day  a  drug  is  delayed  from  market,  sponsors  lose  up  to    

$8m3  

The  percentage  of  studies  that  complete  enrolment  on  <me:    

18%  in  Europe,    

7%  in  the  US1  

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The EHR4CR project

▪  EHR4CR – Electronic Health Records for Clinical Research ▪  4+1 year project (2011-2016), 35 partners, budget >17M€

▪  Objectives & Scope ▪  Provide a scalable platform for trustworthy re-use of EHR data to

support innovation in clinical research and healthcare operations

▪  Unlocking Real World Data for optimising clinical trials

▪  Status ▪  Extended into 2016 for making the transition to a sustainable platform

▪  Initiating a EHR4CR Champion Programme, connecting hospitals to an operational platform, building up experience with pharma

▪  Established the European Institute for Innovation through Health Data – an independent governance body

   

Brought together key stakeholders

35 participants including

pharmaceutical industry, academia ,

hospitals, SMEs, patient associations and public authorities

11 hospital

sites 10

Pharma Compani

es Advisory boards and

other experts

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The EHR4CR objective ▪  Research and develop a trustworthy service platform able to unlock clinical information stored in

EHRs for improving clinical research ▪  Clear focus on three (3) relevant use cases

SAFETY REPORTINGPROTOCOL

FEASIBILITYPATIENT

RECRUITMENT

DATA CAPTURE AND

EXCHANGE

Enabling protocol testing with real world data in potential trial sites rather than with guestimates.

Speeding up recruitment by making EHR data searchable for investigators and establishing a unified communication path between sponsors and sites.

Facilitating EHR data extraction for applications used during trial execution (e.g. prefilling of CRFs and of SAE reports).

   

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Initial services

Protocol feasibility / Trial Design services

§  Optimise protocol eligibility criteria by instantaneously testing them out in multiple sites in various countries

§  Directly identify the countries and specific sites to approach for participation

Trial recruitment services

•  Distribute trial protocols over multiple sites in a uniform way

•  Track recruitment progress in real time

•  Optimal recruitment due to tools provided to hospitals

Starting with a simple service offering for Research Organisations §  Initial focus is on building the

network and introducing the technology in hospitals

§  The two services should be able to demonstrate the value of this initiative to all stakeholders

§  Piloting new services will be done as the need arises

§  The service offering will be expanding as the technology matures

   

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Value for pharma & research organisations

Clear value proposition for research organisations

Better trial design §  Optimising clinical protocol design will reduce costly

corrective measures such as protocol amendments, late addition of new trial countries or sites.

Quicker achieved recruitment targets §  Computer assisted patient identification tools result in

accelerated identification, fewer patients missed,…

Increase revenue §  The platform will reduce the elapsed clinical trial time, which in the

end translates into a quicker time to market and thus additional revenue (increased time on market under patent protection).

Reduce cost §  Less manual work, less corrective measures, etc. lead automatically

to a decrease in total trial cost. Pharma will also avoid the expense and time and effort of opening trial sites which will not yield enough patients.

Overall increased efficiency §  Further automation and optimisation of the clinical trial

process by use of a central platform result in an overall increased efficiency.

Improve trial success rate §  The number of trials failed due to failure to recruit will be

reduced.

   Evidence starting to emerge

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Better quality data

The clinical trial platform stimulates hospitals to focus on the quality of their data. Improved monitoring, performance benchmarking, reporting and management (e.g. reimbursement coding) drives optimization of patient care and improved internal management.

Enhanced reputation

Hospitals and their physicians participating in more clinical trials will get greater visibility in scientific community. Which on its turn will attract more research (trials), top-class physicians and more patients (once reputation gets picked up by the media).

Better patient care More patients will get access to trial drugs and innovative care pathways at no additional cost to the hospital.

Physicians participating in clinical trial are in general more up to date with medical science.

Increased income

Cutting cost will no longer be sufficient to deal with the overall healthcare budget decrease. Hospitals need to search for new revenue streams, the clinical trial platform will help them to attract more trials and thus income.

Value for hospitals

Access to tools

Participation to the clinical trial platform includes free access to a set of tools to explore and analyze patient data.

Anyone familiar with the cost of clinical IT systems understands the value of this benefit.

Value generated at multiple levels: clinical research, overall care provision and revenue

   

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2015 – 2016 Champion Programme

The Champion Programme serves to: §  Further validate and improve technology §  Define (refine) the rules of engagement for

a sustainable ecosystem §  Start building a network of hospitals §  Engage with European Institute for

Innovation through Health Data which aims to govern the EU data re-use ecosystem

   

“A  mul<-­‐stakeholder  collabora<on  aiming  to  accelerate  and  ensure  the  future  of  clinical  research  in  Europe.”  

Targe<ng  hospitals  in    Belgium,  Germany,  Finland,  France,    Italy,  Netherlands,    Poland,  Spain,  Switzerland,  Sweden,  and  US  

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i~HD is registered in Belgium as a not-for-profit organisation

It is being financed by membership fees, by providing services

such as certification and governance and through specifically-funded projects and initiatives

The European Institute for Innovation through Health Data (i~HD) has been formed as one of the key sustainable entities arising from the EHR4CR and

SemanticHealthNet projects, in collaboration with several other European projects and initiatives supported by the European Commission

Guiding  and  catalysing  the  best,  most  efficient  and  trustworthy  uses  of  health  data  and  interoperability,    

for  op<mising  health  and  knowledge  discovery  

i~HD has been formed because a complementary, neutral and not-for-profit organisation is needed

▪  to play a central role in governing and expanding a trustworthy health data driven ecosystem including EHRs and clinical research platforms

▪  to promote the adoption of healthcare standards and of data quality, to enable more effective, safer and better integrated healthcare

▪  to act as a connector between health care and clinical research standards, that are presently developed in silos and impair the interoperability and pooling of health data for research

▪  to promote to society the importance of using health data for research, to improve efficiency through reduced duplications, delays, costs enhance speed and efficiency in clinical studies

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Responding to a convergence of needs

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Need to remove the bottlenecks to accessing and combining health data from diverse sources across Europe

Clinical Research needs

Optimise clinical research processes• achieve faster and more accurate patient identification

• identify sites that have access to the most suitable patients

• reduce protocol amendments

Enhance access to Real World Data• study the use of new medicines in real populations

• conduct comparative effectiveness studies

• monitor long term safety• gather evidence for adaptive licensing

Healthcare needs

Improve quality and safety of care• enhance care co-ordination• increase adherence to clinical evidence

• reduce medical errors and treatment delays

Support patients in self-care and health maintenance

Improve efficiency of care• optimise care pathways to improve outcomes

• collate evidence for public health strategy and decision-making

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Harmonised health information and standards

Solutions for better quality health data, and legitimate uses of data

Quality assessments, certification and audit

Value Assessment programmes

Clinical Research needs Healthcare needs

Best practices in information governance

Intelligence derived from health data e.g. research, outcomes

Enriching knowledge and enhancing care through health data