clinical information systems and translational research · vestrum health’s primary customers are...

Clinical information systems and translational research :: Prokosch HU :: Paris 20.10.2016

Clinical information systems and translational research: Increasing the efficiency of trial feasibility

and patient recruitment

Prof. Dr. H.U. Prokosch Chair of Medical Informatics Friedrich-Alexander-Universität Erlangen-Nürnberg CIO Erlangen University Hospital and past board member of the GMDS

October 20th, 2016


Agenda

2

• Getting the Value from Electronic Health Records (some stakeholder statements)

• Data Warehouse Technology as a basis for Feasibility and Patient Recruitment

• A Hospital-based Architecture for IT-supported Patient Recruitment

• A Pharma-based Architecture for IT-supported Patient Recruitment


Todays Challenge for Clinical Information Systems

3


Getting the Value from EHR

4

Clinical information systems and translational research :: Prokosch HU :: Paris 20.10.2016 5


Disclaimer: Vestrum Health’s mission is to help physicians capture value from their EHR data.

Vestrum Health has developed a proprietary, safe, secure, and regulatory-compliant technology platform that allows participating

physicians to securely transmit their EHR data to a proprietary database, without compromising the stability and security of the their

EHR system.

NEW RETINA MD. FALL 2013, 9-12. http://vestrumhealth.com/files/news/articles/New_Retina_MD.pdf



Disclaimer: Vestrum Health’s mission is to help physicians capture value from their EHR data.

Vestrum Health has developed a proprietary, safe, secure, and regulatory-compliant technology platform that allows participating

physicians to securely transmit their EHR data to a proprietary database, without compromising the stability and security of the their

EHR system.


Vestrum Health has developed . . . . . a proprietary, safe, secure, and regulatory-compliant technology platform that allows participating physicians to securely transmit their EHR data to a proprietary database, . . . . .




To whom does Vestrum sell the data?

Vestrum Health’s primary customers are the pharmaceutical industry, medical device manufacturers (MDM) and the financial

services industry (hedge funds, analysts, etc.). Vestrum will not sell any data to payers, government entities, or attorneys.

Vestrum Health’s primary customers are the pharmaceutical industry, medical device manufacturers (MDM) and the financial services industry (hedge funds, analysts, etc.).



8



9



10



11

IBM Watson Health



12

Revolutionising

• Clinical Trial Feasibility

• Patient Recruitment

• Study Start-up Timelines


Clinical information systems and translational research: Increasing the efficiency of trial feasibility

and patient recruitment

Prof. Dr. H.U. Prokosch Chair of Medical Informatics Friedrich-Alexander-Universität Erlangen-Nürnberg CIO Erlangen University Hospital and past board member of the GMDS

October 20th, 2016


Problems in Patient Recruitment

14

• out of 218 trials,

• 20.6% that were opened resulted in no actual accruals

• 53.7% had fewer than five patients accrued

• less than one-third met their target recruitment within the time originally specified [Dilts and Sandler 2006]

• out of 114 trials (1994 - 2003)

• only 18% of EU trials complete enrolment in time [Campbell et al. 2007]

Dilts DM, Sandler AB. Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol 2006; 24: 4545–52.

Campbell MK, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 2007; 11: iii, ix–105.


Problems in Patient Recruitment

15

• out of 218 trials,

• 20.6% that were opened resulted in no actual accruals

• 53.7% had fewer than five patients accrued

• less than one-third met their target recruitment within the time originally specified [Dilts and Sandler 2006]

• out of 114 trials (1994 - 2003)

• only 18% of EU trials complete enrolment in time [Campbell et al. 2007]

• 50% of clinical trials fail to achieve the target recruitment

• 50% of all trial delays are caused by recruitment problems

• 1/3 of protocol amendments are avoidable Dilts DM, Sandler AB. Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol 2006; 24: 4545–52.

Campbell MK, Snowdon C, Francis D, et al. Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 2007; 11: iii, ix–105.



16

• Patient Recruitment holds a large potential to gain efficiency

• Patient Recruitment Optimization

• starts already with an optimized trial design and

• an efficient feasibility phase

How can trial design,

trial feasibility and patient recruitment be enhanced

based on efficient clinical information systems and EHR data?


A personal review Facing the Challenge


Challenge 1:

• Establish comprehensive clinical data warehouses by tapping and integrating clinical patient data from a multitude of currently separated clinical databases.

• . . . . .

Challenge 2:

• Establishing an IT Infrastructure for Clinical Research . . . . .

Challenge 3:

• Integrate medical record systems and clinical trial databases in order to enhance

• patient recruitment and

• data capture for clinical trials.

A personal review Facing the Challenge


Patient Recruitment: first encouraging results

19


Challenge 1: Establish comprehensive clinical data warehouses

20

J Am Med Inform Assoc. 2012 Sep-Oct;19(5):782-5. doi: 10.1136/amiajnl-2012-000850. Epub 2012 Apr 20.


Erlangen University Hospital (UKER)

DWH implementation had started in 2003

In 2008 we extended the design

- IT Infrastructure for Research

- Research Data Warehouse

Clinical Data Warehouse

IBM Cognos

DWH Server

Routine Clinical Systems

SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries



Translational Research Toolkit

developed at Harvard Medical School



Actually: That´s not really a new idea

Over a 30-month period,

530 doctors, nurses, medical students, and administrators used

the program to search the hospital's clinical database 1786 times.


The TMF is the umbrella organization

for networked medical research

in Germany.

IT for Patient Recruitment

i2b2 Evaluation

2008 - 2009




IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries


Research Portal

i2b2

Query Frontend

Transform


First German i2b2 user group meeting December 2009

26


First European i2b2 user group meeting March 2013

27



28


. . . . .



HEGP Clinical & Research Information Systems

30

StructuresHEGP hospital

Biobank

Translational research building

Information systemADT, EHR, CPOE, Appoint.

CDW (i2b2)

CDW (i2b2+tranSMART)

IT committeesIT Governance/IT committee

Ethical/research committee

Institution Review Board (IRB)

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

From Prof. Dr. Patrice Degoulet. 15 Years with an Integrated Clinical Information System at the Pompidou University Hospital. Erlangen, 26. March 2013


HEGP Business Data Warehouse

31

+’omics

CDW

Health care Health Information System

Clinical Research

Pathology

DRG

Biology

EHR forms

Imaging

Browser and Analysis

tools available

for MD & Pharm

EHR reports i2b2

tranSMART

ET

L

once a

week

‘omics data

ET

L

Structured data

from research

studies

ET

L

Rx

BDW



HEGP Business Data Warehouse in use

32

i2b2 CDW queries (Jan. 2011-Dec. 2012)

• 170 MD + Pharmacists trained

• 1864 type 1 requests

Type 2/3 project (Jan. 2011-Dec. 2012)

● i2b2 projects

● 39 submitted projects

● 19 accepted projects

• i2b2 + tranSMART

● 3 submitted projects

● 3 accepted projects


Clinquery 1989: Over a 30-month period, 530 doctors, nurses, medical students, and administrators used the program to search the hospital's clinical database 1786 times.


User friendly query frontend for feasibility studies & cohorte identification

Feasibility Phase / Kohorten Identifikation

Projektantrag Ethikkommission

Aufnahme in Studienregister

Patienten Identifikation /Rekrutierung

Studiendurchführung

Ontology: clinical filter parameters

Query: boolean logic


Feasibility Phase / Kohorten Identifikation

Projektantrag Ethikkommission

Aufnahme in Studienregister

Patienten Identifikation /Rekrutierung

Studiendurchführung



Cohorte identification visualisation of simple demographic distributions


Cohorte identification patient event timeline / biomaterial picklist


Automated import of biomaterial picklist into Biobank Information Management System



IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Challenge 2: Establish an IT Infrastructure for Clinical Research

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist



IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Challenge 2: Establish an IT Infrastructure for Clinical Research

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol


Clinical Care and Translational Research three separate worlds

Co

mm

un

ica

tion

Se

rve

r

EHR

DWH

Feasibility Phase / Cohorte Identification

Study Protocol

Registration in Trial Registry

Patient Recruitment

Clinical Trial documentation

Pharmacovigilance

The

clinician

The clinical

researcher

The basic

researcher


Challenge: Reuse EHR Data for Translational Research

Co

mm

un

ica

tion

Se

rve

r

EHR

DWH

Feasibility Phase / Cohort Identification

Study Protocol


Patient Recruitment


Pharmacovigilance

The

clinician

The clinical

researcher

The basic

researcher

Single Source Concept


Challenge: Reuse EHR Data for Translational Research

Co

mm

un

ica

tion

Se

rve

r

EHR

DWH

Feasibility Phase / Cohorte Identification

Study Protocol


Patient Recruitment


Pharmacovigilance

The

clinician

The clinical

researcher

The basic

researcher



44







45






Patient Recruitment: first encouraging results

46


EHR-supported Patient Recruitment

University Hospital Münster

University Hospital Erlangen

University Hospital Düsseldorf

University Hospital Gießen

University Hospital Heidelberg

Agfa Orbis

Siemens Soarian

Siemens Medico

Homegrown

Siemens IS-H.med

Design of a generic architecture for a patient recruitment support

integrated into a clinical information system


Generic architecture for EHR-supported patient recruitment

Trial Administration Module

Query Generator /

Query Module

Patient Data

Notification Module

Screening List Module


Co

mm

un

ica

tion

Se

rver

EHR

DWH

UKER architecture for EHR-supported patient recruitment


Co

mm

un

ica

tion

Se

rver

EHR

DWH

Trial Admin. Module

Query Generator /

Query Module

Notification Module

Screening List Module

Patient Data



Co

mm

un

ica

tion

Se

rver

EHR

DWH


Notification

Module

Trial

Admin.

Query

Generator

Query Module

Notification

Module

Screening

List


Screening List Module within the EHR of Erlangen University Hospital

Patient ward Proposed trial


Screening List Module at Erlangen University Hospital linked with the EHR overview

Station Vorgeschlagene Studie



55





Getting the Value from EHR Data for the Hospital

Getting the Value from EHR Data for the Pharma Industry

out of 114 trials (1994 - 2003)

only 18% of EU trials complete enrolment in time

[Campbell et al. 2007]


The Pharma View on Feasibility and Recruitment

http://www.uni-duesseldorf.de/

http://www.embl.de/index.php

http://www.eclinicalforum.org/main/Home/tabid/36/Default.aspx

http://www.dundee.ac.uk/

http://www.inserm.fr/

http://www.hug-ge.ch/index.html

http://www.xclinical.com/en/home_de/

http://www.manchester.ac.uk/index.php

http://www.google.se/imgres?imgurl=http://ceoworld.biz/ceo/wp-content/uploads/2009/09/novartis-logo.jpg&imgrefurl=http://ceoworld.biz/ceo/2009/09/03/novartis-cell-culture-based-h1n1-swine-flu-vaccine-celtura-may-work-on-fewer-doses&usg=__rhZisG-3JYL2r9FHqlMMClbgRZ8=&h=446&w=1846&sz=57&hl=sv&start=1&zoom=1&itbs=1&tbnid=iy0utMYOJqhEPM:&tbnh=36&tbnw=150&prev=/images?q=Novartis&hl=sv&sa=G&gbv=2&tbs=isch:1


Patient

health records

De-identified data

for

Clinical Research

Courtesy from: Andreas Schmidt; EHR4CR Project Coordinator Deputy and

Business Model Industry Lead, Hoffman-La Roche AG, Schweiz

Protocol feasibility

(PFS)

Patient recruitment

(PRS)

Clin. trial execution

(CTE)

The Pharma View on Feasibility and Recruitment


Architecture for Pharma based EHR-supported patient recruitment

. . .

. . .

http://www.dundee.ac.uk/


Architecture for Pharma based EHR-supported patient recruitment

What´s next


Patient Recruitment Portals (1)


Protocol feasibility

Patient recruitment



„Pharma Portals“ towards faster trials

68



IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Integrate Pharma Portals into an IT Infrastructure for Clinical Research

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol



IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol

Pharma

Portal




IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol

Pharma

Portal


IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol

Pharma

Portal




73





Getting the Value from EHR Data for Hospitals

and for the Pharma Industry



IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol

Pharma

Portal


IBM Cognos

DWH Server


SAP IS-H

Apotheke

Labor

Soarian

Pathologie, ...

Standard

Reports

Individual

Queries

Research Portal

i2b2

Query Frontend

Transform

Starlims

Biobank

Picklist

Copy

Research Project

I2b2/

Transmart

Project-

Instanz

Export

Statistics-

Package

Internal

Review Board (IRB)

Study

protocol

Pharma

Portal



Merci Beaucoup! Thank you very much!

Dear Patrice,

many greetings and all the best for you

from the whole Erlangen Team

[email protected]

But there are still many challenges ahead . . .

clinical information systems and translational research · vestrum health’s primary customers are...

Documents