Introduction about our activities on diffusion and implementation of CDISC

standards in Translational Research Informatics Center

CDISC Japan Interchange 20th/7/10Foundation for Biomedical Research and Innovation

（Kobe, Japan）Translational Research Informatics Center（TRI）

Kotone Matsuyama

Self introduction

Name– Kotone Matsuyama, Ms.

Job titles– Project Manager (Dept. of Research and Development

Project

Management Group)

– Supervisor Pharmacist

(Dept. of management investigational drugs)

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Summary of today’s presentation

Activities on implementation of CDISC standards– a demonstration experiment with CDISC standards by

using a model clinical protocol and CRFs

Activities on diffusion of CDISC standards– TRI published a Japanese version of CDISC Glossary

(Ver.7.0)

Introduction of TRI

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Summary of today’s presentation

Activities on implementation of CDISC standards– a demonstration experiment with CDISC standards by

using a model clinical protocol and CRFs

Activities on diffusion of CDISC standards– TRI published a Japanese version of CDISC Glossary

(Ver.7.0)

Introduction of TRI

A demonstration experiment

Purpose–

To verify the efficiency of the data interchange tools implemented in relation to CDISC standards by using a model clinical protocol and CRFs

that NOT match to one.

Model protocol–

Study product: Yokunal

–

Disease: Prostate cancer

–

Schema

Prostate cancer pts.

Group A: MAB+Yokunal (12mo.)

Group B: Only MAB (12mo.)

Follow up 3yrs.

MAB: Maximum Androgen Blockade

Whole image of the project

SDTM＊standard

CDASH・SDTM

Databaseconfiguration

SDTM standard

Output dataset

CDASH standard

Annotated CRFs

＊Not match to CDISC standards

Study protocol（sample）

CRF*（Sample）

InputInput

Conversion to CDISC standard data model.Conversion to CDISC standard data model.

CDASH＊standard

*CRFs : Paper CRFs (not e-CRFs)

mapping

Clinical study protocol

Cover

index

We made a sample protocol

Clinical study protocol (contd.)

Schema Eligibility criteria

Clinical study protocol (contd.)

Treatment plan Visit schedule

Registration form and CRFs

Registration form CRF (baseline)

Registration form and CRFs (contd.)

CRF (treatment)

Data mapping

Database(Access)

SDTMdataset

Mapping toolextraction conversionCRF

Database definition document(CDASH・SDTM)

Mapping definition document(SDTM)

Annotated

CRF(CDASH)

Input data

ETL tool

ETL: Extract/Transform/Load

ETL tool:IBM InfoSphere DataStageInformatica PowerCenterSAS Data Integration Pentaho Data IntegrationTalend Open Studio (easy-to-use GUI interface )

coding conventions

Problem on coding

Many items didn’t match CDASH domain–

CRFs

were not designed to consider CDISC standards

What is the best answer?–

To fit the existing data domain?

–

To create new data domain?

The reason is…–

Because we hold back from adding new domains in coding conventions so frequently.

–

Uncertain problem

what domain will choose and add as new domain from many domain candidates (especially for objectives such as efficacy orstudy endpoints)

Problem on coding (contd.)

Ex) Wong Baker FACES Pain Rating Scale (secondary objective)

There are three ways to match domains1.

To select PE domain regard the item as physical finding

–

Merit: PE is the existing domain–

Demerit: it may not match the name and content

2.

To select QS domain which is in SDTM standard and define it as CDASH domain

–

Merit: QS domain is the existing domain and may be suitable for score data–

Demerit: QS domain doesn’t exist in CDASH

3.

To define custom domain

–

Demerit: It may be defined as the similar domain in near future

Annotated CRFs

match to CDASH standard data items

Database Configuration

DB

Patient data

Enrollment CRF

Fixed CRFCRF(Pre-Printed)recruitment

DB (ENROLL)

CDASH DB

(CRF)

DB (MASTER)

Enroll data

Master DB

Control item

Enroll data

write- down

Pre Print

Database Configuration (contd.)CRF

Relationship to Master-CRF

Enrollment

Master

Mapping tool

Every process have been programmed in each icon.

Datasets will be changed into SDTM format automatically by running the programming.

Output (SDTM conversion)LB

PE

Short summary of the project

We tested a data conversion tool applied for a data sets that followed SDTM standards.

We used a model clinical protocol and CRFs that NOT match to CDISC standards. To make annotated CRFs, it was very difficult to apply CDASH, but data mapping to SDTM went well after all.

We will provide results of this project via TRI website (under construction).

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Summary of today’s presentation

Activities on implementation of CDISC standards– a demonstration experiment with

CDISC standards by using a model clinical protocol and CRFs

Activities on diffusion of CDISC standards–

TRI published a Japanese version of CDISC Glossary (Ver.7.0)

Introduction of TRI

TRI activities on Dissemination of Therapeutic and Clinical Research Information

PDQPDQ®® http://www.cancer.gov/cancertopics/pdq/

Cancer Information Japan (PDQ Japanese Ed.)

★TRI made License agreement with NCI★Contents as below:PDQ® (Japanese Ed)Drug Information,Clinical trials,Dictionary of Cancer Terms …etc.

TRI activities on Dissemination of Therapeutic and Clinical Research Information (contd.)

NCCN guideline

Japanese Translation of CDISC Glossary

Translation of CDISC clinical research glossary (Ver.7.0)

Design a independent new contents in TRI website with simple search function

Japanese Translation of CDISC Glossary (image)

Ex) Clinical efficacy

Japanese Translation of CDISC Glossary (image (contd.))

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Summary of today’s presentation

Activities on implementation of CDISC standards– a demonstration experiment with

CDISC standards by using a model clinical protocol and CRFs

Activities on diffusion of CDISC standards–

TRI published a Japanese version of CDISC Glossary (Ver.7.0)

Introduction of TRI

Kobe Medical Industry Development Project

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Translational Research and Informatics Center (TRI)

One of the centers in Foundation of Biomedical Research and InnovationPlaces at Medical Frontier of Kobe CityFounded 2002, both of MEXT and Kobe City

MEXT: Ministry of Education, Culture, Sports, Science and Technology Japan

Action Plan

Goal–

Improvement of prognoses for intractable human diseases, including cancer, heart disease, stroke and Alzheimer’s disease

Mission–

Innovation of standard treatments

–

Development of new diagnostic therapeutic and preventive strategies

Approach–

Plan and efficiently conduct every phase of clinical trials and outcome researches

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Main Projects

Promotion and Management of Translational Researches (TR)

Management and Operation of Clinical Trials and Large Cohort Studies

Dissemination of Therapeutic and Clinical Research Information

Construction of Integrated Database System for Genomic and Clinical Data

Development of New Statistical Approaches for Disease-related Genomic Information

Ongoing TRI Support Projects

Phase Ⅰ、Ⅰ-Ⅱ 7

Phase Ⅱ 16

Phase Ⅲ 15

Outcomes 19

STAT 3

Total 60

Jul. 2010

Flowchart of clinical study support

Application

Medical Review

Start of study support

Protocol & CRF development

System development / Registration

Data collection

Data analysis

We will investigate documents below;1. Support Application (Form)2. CV 3. Protocol (Draft)

Confirmation of schedule

Configuration of study outcomes, other elements

Development of EDC/DM system and Database, Clinical trial registration

Detailed progress, Data management

Study reports

See our website for detail information（http://www.tri-kobe.org/）

Summary

We verified the efficiency of the data interchange procedures implemented in relation to CDISC standards –

We tested a new data conversion tool applied for a data sets that followed CDISC standards.

–

We faced to many problems caused by model protocol and CRFs

that not considered CDISC standards. But we overcame

the difficulty as we devised an effective method of coding.

–

We will promote adaptation to the CDISC standards moreover.

We translated CDISC Glossary in Japanese and placed our website with a simple search tool to diffuse everyone who wishes to know about technical terminology in clinical trials and also CDISC standards.

Co-presenter

Translational Research Informatics Center–

Yoji Nagai, Vice-director

–

Takako Jyouno , Manager, Dept. of Information Technology

–

Masafumi

Okamoto, Dept. of Information Technology

CMIC Co., Ltd. (data conversion tool )–

Kiyoteru Takenouchi, Corporate Officer, eClinical, Corporate Planning Dept.

–

Daisuke Kikawa, Manager, Corporate Planning Dept./Group Leader, eClinical

Center, CDM Div.

–

Hidenori

Hamano, eClinical

Center, CDM Div.

–

Hiroyuki Omori, eClinical

Center, CDM Div.

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Translational Research Informatics center

(http://www.tri-kobe.org)

Cancer Information Japan

(http://cancerinfo.tri-kobe.org)

Research Promotion for Innovative Therapies against Cancer, MEXT

（http://ctrp.tri-kobe.org/）

Coordination, Support and Training Program for Translational Research, MEXT

(http://www.tr.mext.go.jp/)

Thank you for your attention