Perspective of the Researcher. Perkins R. eHealth week 2010

Enabling Clinical Research

Through Effective Use Of

Patient DataPerspective of the Researcher

Richard Perkins

President, eClinical Forum

Overview…

1. Some Relevant Statistics

2. A Different Future

3. The Challenge

4. Why Now

5. How EHRs Could Enhance

Clinical Research

To understand

the rationale,

needs,

challenges,

potential

solutions…

2

Some Relevant Statistics…

HealthcarePharma Research

Bringing a new treatment

to the market costs >800 M

Euro and increases at

~10% a year

Clinical research uses 55-

75% of R&D budget

>37,000 Clinical Trials

3

250,000 patients participate in

European clinical trials a year

Recruited by 4200 investigators

Completing ~1400 data points

per patient

A typical trial has 6000 data

queries (time and cost to

correct)

Generates 525-2025 M Euro for

healthcare

Physician /

Investigator

58% of trials do not meet

projected recruitment

rates!


Growth in Electronic Data Capture to 61% of

ongoing trials (from 13% in 2001)…

N=131

0%

5%

10%

15%

20%

25%

30%

35%

40%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

% R

es

po

nd

ers

Percentage of EDC Trials Ongoing at Site

No EDC Trials All EDC Trials

‒ To provide faster,

better quality and

more reliable data

to support safety

and efficacy

Source: eClinical Forum Site Survey 2009, European data

4

Average of 61%

of trials ongoing

at respondent

sites use EDC

37% only

use EDC

EU GPs (2008)


EU Hospitals (2004)

50%

Growth of EHRs to >50% …– Enhance patient safety

– Improve quality of healthcare

– Reduce healthcare costs

67-92%

5 Source: Benchmarking ICT use among General Practitioners in Europe, April 2008

Source: Personal communication - ICT use

among Hospitals in Europe, 2004


and… The percentage of patient data perceived

as entered into EDC system and the patient

record?

0%

10%

20%

30%

40%

50%

60%

70%

0 10 20 30 40 50 60 70 80 90 100

% R

esp

on

ders

Percentage Duplicated n = 124

Source: eClinical Forum Site Survey 2009, European data

70-100%!

6

A significant

opportunity for

efficiency gains!

In your opinion what percentage of data that was

entered into the CRF was also entered into the

patient file or notes?

A Different Future…

We Need… a common understanding and approach

We Need… to connect Healthcare and Pharma/Academic Research

7


• 72% of investigational

sites consider

connecting healthcare

and clinical trial

systems to be of

benefit!

Connect Healthcare and Research …For more efficient use of patient data, to avoid redundant

entry and to improve trial performance

72%

26%

3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Yes No MissingO

f B

en

efi

tSource: eClinical Forum Site Survey 2009, European data

8


Interoperable Ideal• EHR and research systems work

seamlessly together so that groups

benefit from data access and mining

capabilities across healthcare and

research data sets

• Research systems and healthcare

systems sit on the same spine

• Systems conform to the same data

exchange standards

Current Divided• EHR systems holding source for data used in

clinical trials may not meet essential regulatory

requirements

• Clinical care data required for clinical trials is

entered into EHR and into clinical trial systems

• Research holds source data not part of normal

clinical care

• Redundant data entry, transcription errors and

source issues cost healthcare and industry

time and money.

Current Divided

Emerging and Future EHR-Research Connectivity and Complexity

Clinical Trial

System

Healthcare System

Imagine… Patient Data Exchange Between Healthcare and Drug Development Systems

Integrated Future •EHRs used to…

•Evaluate Patient Populations

•Accelerate Patient Recruitment

•Capture CT Data

•Exchange CT Data

•The EHR becomes the patient data repository

Integrated FutureInteroperable Ideal

9


Benefiting all stakeholders…

Healt

hcare Identification of target population

Reduced effort for data provision leaves more time for patient care

Simplified safety reporting and managementPotential to conduct more research

Familiarity of one interface

Pati

en

t

New innovative therapies available earlier

Higher quality data provides greater safety

Real-time identification of safety issues and trends A

uth

ori

ties Higher quality, reliable data

from validated sources under investigator control

Lower cost and faster approval of new therapies

Mining of data

Ph

arm

aR

esearc

h 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 efficienciesVirtual trials…10

Healthcare Pharma Research

The Challenge…

Entry of

Patient’s Clinical

Data

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 …

Various standards, levels of system validation and integration, data structure depending on country,

region, institution.

Systems validated & compliant to Industry & Regulatory standards &

policies e.g. CSUCI, ICH GCPPhysician /

Investigator11

1. PoliticalRemoving obstacles, linking

stakeholders and driving the need for change

Why Now…

Political, Cultural & Technical Solutions are Starting to Bridge the Gap

Future Connected

Healthcare & Research

StandardsCommon data

standards allow

movement of

data between

healthcare and

research

SystemsReliable,

validated

systems meet

healthcare and

research

requirements

ProcessControlled process for

release and transfer

of data meets bio-

ethical requirements

HANYS

FP7 ICT IMIBRIDG EHRCR

Munich

(InferMed:

Siemens)

APHP/

INSERM

2. CulturalStakeholders see CR as a special

case for use of EHR data

3. TechnicalProjects are developing solutions to

individual components

The concept has been proven in

single site, technology instances12

13

Platform

Integrated Technology

and Interoperability

Layer

How EHRs Could Enhance CR…

Via a standardised, scalable platform that connects healthcare and drug development systems…

« Intelligent » computer-readable

protocols automate querying to

evaluate patient populations,

data collection, rules etc

Extended semantic and ontological

directories cover research

archetypes in multiple languages

Standardised interfaces support

multiple data exchange

standards for healthcare and

research

HL7 Messages

Edifact Messages

EN13606 Extracts

Proprietary Formats

Hea

lth

ca

re E

nvir

on

me

nt

2-way exchange of pseudo-

anonymised data eliminates

redundant entry

Use of standard infrastructure allows

for multiple CT service providers

Patients can be connected to

clinical trials to improve

recruitment

Ph

arm

aE

nviro

nm

en

t

Patient Population Query

Anonymised Aggregated Data Extracts

CT Patient Datafrom/to EHR

Data Exchange

Data Collection Quality Rules

SAE

How EHRs Could Enhance CR…

… operating within a sustainable business model

HL7 Messages

Hea

lth

ca

re E

nvir

on

me

nt

Organisation• Role of Ethics Committees, TTPs etc

• Governance and oversight

• Support infrastructure

Process• Qualification/certification

• Revenue , investment and cost models

• Workflow of activities, interfaces, rules

Edifact Messages

EN13606 Extracts

Proprietary Formats

Platform

Integrated Technology

and Interoperability

Layer

Business Model

Data protection and ethics

requirements met

14

Patient Population Query

Anonymised Aggregated Data Extracts

CT Patient Datafrom/to EHR

Data Exchange

Data Collection Quality Rules

Ph

arm

aE

nviro

nm

en

t

SAE

Qualification of systems,

processes, organisations

balance cost and oversight

Revenue and cost models

define value-added and ROI

to drive sustainability

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

Key Messages…

5. There are challenges but they can be met by adapting and integrating existing technologies and standards to achieve interoperability

[email protected]

16

6. A sustainable European business model to facilitate re-use of patient data is needed that meets business, operational, ethical and data protection requirements

Enabling Clinical Research

Through Effective Use Of

Patient DataPerspective of the Researcher

Richard Perkins

President, eClinical Forum

Health & Medicine

Perspective of the Researcher. Perkins R. eHealth week 2010