Implementation and Operation of CDISC ODM-based EDC by UMIN

(1)

1

Implementation and Operation of

CDISC ODM-based EDC by UMIN

Takahiro Kiuchi, M.D., Ph.D.

UMIN Center,

The University of Tokyo Hospital, Tokyo, Japan

(2)

Content

1. CDISC standards and academic research

2. What is UMIN and UMIN INDICE?

3. Implementation and operation of CDISC

ODM-based EDC by UMIN

4. Practical development and operation of a real

clinical trial by CDISC ODM-based EDC with

Fukushima Prefectural University Hospital

(3)

1. CDISC standards and

academic research

(4)

CDISC Standards for

regulatory clinical trials

Practical use

in U.S.A.

Lab

（

XML

）

ODM

（

XML

）

_{SDTM (Clinical)} SEND (Non-clinical)

ADaM (Statistical analysis)

⇒SAS xpt CRT-DDS (Metadata) ⇒PDF or XML

SDTM

SEND

ADaM

SDTM

SEND

ADaM

CDASH

(Variable

names)

PR

(Protocol)

Clinical laboratory

company

（

XML

）

Regulatory

agency

Hospital

_{Trial use}

Pharma

in U.S.A.

and Europe

(5)

CDISC Standards for

academic research

Lab

（

XML

）

ODM

（

XML

）

SDTM

ADaM

CDASH

(Variable

names)

PR

(Protocol)

（

XML

）

Academic

publishers

Hospital

Academic

data center

Paper

CDISC Standards can be used

for academic clinical trials and

epidemiological studies

as they are.

Clinical laboratory

company

(6)

2. What is UMIN and

UMIN INDICE?

(7)

UMIN

(University hospital Medical Information Network)

• Important information infrastructure for academic activities in

biomedicine

• Versatile academic information services, including research,

education, and clinical practice

The Univ. of Tokyo

Hospital

National University Hospital Council

Control

320 thousands

Registered users

50 million page views per month

(8)

UMIN Services -Overview

Information and database services

Homepage etc. hosting services

Communication support services

Research

Education

Clinical practice

University hospitals

Multipurpose

Collection of biomedical web sites Medical terms glossary

Research institutes and hospitals database

Open homepage hosting service Member-only homepage hosting service Archival homepage hosting service Wiki

Blog

VOD hosting service

Email service, including encrypted email Mailing list service

BBS service

Online voting system

Intoxication database (Yamaguchi Univ.) HIV manual (Hokkaido Univ.)

Drug information database

Drug information text database for pharmacists

Medical supplies and materials database

Official documents database University hospitals guide

Master database for patient fee calculation Standardized disease nomenclature database Mailing lists

Member-only homepages

AC

Academic societies and meetings database

ELBIS

Electronic Library for Biomedical Sciences

FIND

Fund Information Database

INDICE

Internet Data and Information Center

ROCOLS

Recruiting System for Our Colleagues and Students

CTR

ICMJ-accredited clinical trial registry

EPOC

Online evaluating system of post-graduate clinical training for physicians

Debut

Online evaluating system of post-graduate clinical training for dentists

Web-QME

Web-based Quality Management system for Educational effectiveness

VHP

(9)

UMIN INDICE

(Internet Data and Information Center for Clinical Research)

ＵＭＩＮ

_INDICE

Information

Communication Mailing list

managementsystem Homepage hosting service

Original software package for clinical and epidemiological research

Largest internet clinical research data center in Japan

SaaS = Software as a Service

Hardware Security User management

Internet

Data collection

(10)

Usage statistics of

UMIN INDICE

0 200000 400000 600000 800000 1000000 1200000

Apr-00 Apr-02 Apr-04 Apr-06 Apr-08 Apr-10

0 20 40 60 80 100 120 140 160 180

April-00 April-02 April-04 April-06 April-08 April-10

Accummulated

Under operation

(11)

Web-based data collection

by UMIN

Web browser UMIN INDICE

UMIN Center

Hospital

Manual entry of digitalized laboratory and drug prescription data

(laborious and vulnerable to miss transcription)

Web-based

Electronic Health Record

Laboratory data Drug prescription

(12)

3. Implementation and operation of

CDISC ODM-based EDC by UMIN

(13)

Web-based data collection

by UMIN

Web browser UMIN INDICE

UMIN Center

Hospital

Web-based

(14)

Procedure for developing

CDISC ODM-based EDC

in UMIN

1. Analysis of a protocol and CRFs

2. Development of web-based EDC server system

3. Development of routine which processes CDISC

ODM-based data and accommodate them to web-ODM-based EDC

server system

4. Development of routine which extract trial data from

web-based EDC server system and create CDISC

ODM-based data.

5. Development of templates of CDISC ODM which are

sent from hospitals to UMIN.

(15)

CDISC ODM and Web-based

data collection by UMIN

(2009/11/6)

Web browser

UMIN INDICE

UMIN Center

Hospital

Web-based

Internet

CDISC ODM-based

Full or semi-automated fulfillment of digitalized laboratory and drug prescription data

(16)

UMIN needs partner hospitals

for CDISC ODM-based EDC

UMIN could receive CDISC ODM data in early

2009.

But were there any hospitals which develop

CDISC ODM-based research data submission

system linked to EHR, using their own funds?

(17)

Implemention strategy for development

of CDISC ODM-based research data

submission system linked to EHR

Data automatically or semi-automatically

collected from EHR are limited to

demographic,

laboratory, and drug prescription data,

which

usually covers more than half of trial data.

RFD (Retrieve Form for Data), which is based on

XForm technology, is not used

because the

technology is immature and the implementation

cost is expensive.

(18)

Implementation procedure for development

of CDISC ODM-based research data

submission system linked to EHR

1. Development of CRF entry system

2. Development of a routine for automated or semi-automated fulfillment of

demographic, laboratory, and drug prescription data

3. Development of a routine for checking CRF data

4. Development of a routine for creating CDISC ODM from CRF data

5. Submission of CDISC ODM-based data

TP 4.5mg/dl Cr 1.1mg/dl TP 4.5mg/dl Cr 1.1mg/dl TC mg/dl Automated entry Deficit check TP 4.5mg/dl Cr 1.1mg/dl TC110mg/dl TP 4.5mg/dl Manual entry CDISC ODM Conversion to CDISC ODM CDISC ODM-based data submission CRF entry system

(19)

Future perspective of the development of

CDISC ODM-based research data

submission system linked to EHR

Packaging

1. Proprietary implementation of each hospital for each trial

2. Vendor packaging

1)Vendor-specific module installed by a vendor for each trial

2)Vendor-specific module installed by a hospital for each trial

3)Vendor-specific module automated installed online for each trial

4)CDISC standardized module automated installed online for each trial

Development in most EHR vendors

Interoperability of CDISC ODM

(20)

4. Practical development and operation of

a real clinical trial by CDISC ODM-based EDC

with Fukushima Prefectural University Hospital

(21)

Overview of the clinical trial

Title

Effect of topping up of Toremifene to preoperative chemotherapy of

breast cancer

Principal investigators

Seiichi Takenoshita and Tohru Ohtake

The number of cases planned

20 cases

The number of participant institutions

7 hospitals, including Fukushima Prefectural Univ. Hospital

The study start date

(22)

22

EHR and CRF data entry form

EHR

_{CRF data entry form}

(23)

Using Yahgee

for the implementation(1)

What is Yahgee

1)Software tool

Data entry forms can be developed and corrected by users

themselves (hospitals).

2)Interface for most EHRs sold in Japan

Data can be entered and extracted from most EHRs sold in Japan

through Yahgee.

Yahgee

A company’s

EHR B company’s EHR C company’sEHR

Yahgee Yahgee

Yahgee interface Yahgee interface

(24)

Using Yahgee

for the implementation(2)

Web

interface CDISC ODMinterface

CDISC ODM

interface CDISC ODMinterface

UMIN INDICE

A company’s EHR B company’s EHR Yahgee A company’s

EHR B company’sEHR Yahgee

Yaghee interface Yaghee intereface

CDISC ODM interface CDISC ODM interface

Fukushima Prefectural Univ. hospital

R hospital

(25)

Why the real clinical trial,

based on CDISC ODM,

realized in Japan first.

Realized as an academic (non-profit) clinical trial

・It is difficult to realize a real EDC in regulatory data collection, using new and

immature technology like CDISC Standards.

・CDISC Standards are misunderstood as those for only new drug application. In

fact, their scope are much wider now.

・Pharma companies concern obligatory CDISC-based new drug application over

CDISC-based EDC.

Web-based academic EDC system - UMIN INDICE

Practical approach for the development of CDISC ODM-based research

data submission system linked to EHR

1) Data collected from EHR are limited to demographic, laboratory, and drug prescription data.

2) RFD (Retrieve Form for Data) is not used because the technology is immature and the implementation cost is expensive.

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Thank you for your attention.

The presenter

’

s doctor thesis

Research on the Use of World Wide Web for a Data Management System for Use in Multi-institutional Clinical Trials

Published papers related to the doctor thesis

1) Kiuchi T, Ohashi Y, Konishi M, Bandai Y, Kosuge T, Kakizoe T: A World Wide Web-based user interface for a data management system for use in multi-institutional clinical trials - Development and experimental operation of an

automated patient registration and random allocation system. Controlled Clinical Trials 17:476-493, 1996

2) Kiuchi T, Kaihara S: C-HTTP - The development of a secure, closed

HTTP-based network on the Internet. Proceedings of the 1996 Symposium on Network and Distributed System Security, IEEE Computer Society Press, 64-75, 1996

3) Kiuchi T, Kaihara S: Automated generation of a World Wide Web-based data entry and check program for medical applications. Computer Methods and