All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute caBIG Implementation Strategy...

All Rights Reserved, Duke Medicine 2007

Duke Cancer InstitutecaBIG Implementation Strategy

Presented to caBIG Architecture WS

May 06, 2011

Pankaj AgarwalDuke Bioinformatics Shared ResourceDuke Cancer Institute


Agenda

• Duke Cancer Institute• caBIG Development and Adoption• Building Blocks• caBIG® Implementation Framework• Benefits of caBIG® Adoption• Current Pilot• Future Plans


Duke Cancer Institute

• Duke Hospital is in the top 10 “Honor Roll” hospitals and the top in the South by U.S.News & World Report.

• Top-Ranked in Cancer Care hospital (12th)• Significant expansion is underway…


Duke Cancer Institute

• 7 floors, including 3 clinic floors• 267,000 square feet• Construction began: early 2010• Construction complete: early 2012• Estimated project cost: $222 million


caBIG Development

– CTMS Knowledge Center– Cancer Central Participant Registry (C3PR)– caTRIP

• Many elements part of other caBIG applications

– RProteomics– VCDE Mentorship– Architecture Mentorship


caBIG Adoption

– Flagship C3D implementation• Many trials in production, many more in development

– caAERS (CALGB and Duke) (recommended)– C3PR multi-center pilot – caGRID– RProteomics by June 2011– caArray


Integration Hub

CTMS(eResearch)

CDMSC3D

(Oracle Clinical)

Safety Desk(ExtraView)

S/AE Reporting(caAERS)

API

Web Service

Pull Study Status/Agentfrom eResearch

MedWatch input from e-mail, fax, paper,

caAERS

Local investigator assessment for IRB

routing determination

Local IRB and/or affiliate sites

(FDA for SAEs)

MedWatch form generation for

Duke held IND/IDE

Promised API

Clinical Connector

eIRB(Click

Commerce)

Protocol #Short Title

Investigator nameStudy Status (initial)

Data Entity Overview

This diagram illustrates data in clinical trials research.


Program Project (P01)Proposal

This flow diagram illustrates the Program Project (P01) Proposal.

Data Export Process

Invoice

Velos eResearchClinical Trial Management System ( CTMS )

Protocol/ Patient Management

BudgetReport/Financial

Data

Investigator/ CRC

Regulatory DocsBudget

Trial Protocol Dev .

DUKE Systems

caBIGTM

Applications

Invoice

Velos eResearchClinical Trial Management System ( CTMS )

Protocol/ Patient Management

BudgetReport/Financial

Data

Investigator/ CRC

Regulatory DocsBudget

Trial Protocol Dev .

DUKE Systems

caBIGTM

Applications

C3D Bladder (M-I)

Protocol

C3D BladderProtocol

Integration Hub

Reports

Analyses

Reports

Analyses

Via web service

iReviewTM

Query

Report Interface

iReviewTM

Query

Report Interface

Tool and Investigator

Report

Report

Report

Investigator

Report

Report

Report

caTissue

Web Service

Cancer Adverse Event Reporting System (caAERS)

ClinicalConnector

SAS Datasets


Benefits of caBIG Adoption• C3D

– Top-shelf CDMS (with CBIIT tech. support)– Regulatory compliant (21 CFR Part 11)– Shared Global Library (parent-child)– caDSR-Direct (local curation ability)– Thousands of Common Data Elements– Development curve

• Less steep now, new trials up much faster• More cluster (brain, breast, etc) replication


Supported Projects on caBIG Platforms

Goal: All Investigator-initiated Clinical Trials•Currently ~40 trials in production or development

– Single and multi-center– Both IND/IDE and Registry

•International– Launching first trial with Beijing Cancer

Hospital• …more to come

•Funding Mix – Gov’t – NIH (NCI, NINDS, etc) and DoD– Foundation (Komen, etc.)– Industry/Pharma


Duke-Beijing Abraxane Trial

First CT collaboration

caTissue-based tumor registry

Future network in China


C3PR Multi-center Pilot (Completed)

• PANVAC multi-center vaccine study– Grid-enabled– Secure– Accessible

Dorian

GTS

CDS

webSSO

caXchange

Key

IdP

Study ServiceRegistration

Service

XYZ Cancer Center


Adoption In Progress

• caTissue– Pilot implementation underway– Potential for broad institutional adoption

• caArray – Installed– caGrid enabled

• DSIC tools (being evaluated)– Primarily to meet data sharing requirement


Other Projects

CCSG Core Grant Supplements• CTRP Early Adopter• ADOPT RDC• Center Deployment Lead

caBIG Participant Contracts• Architecture (Pankaj Agarwal)• VCDE (Sal Mungal)


Future Plans

• C3D– Streamline trial start-up with eCRF

Harmonization– Exchange data with caAERS– Complete integration with Velos eResearch

• Expanded use of caARRAY by Bioinf. group• China

– Set-up local Suite environment in Beijing– Build-out multi-center Chinese network


Questions?

Q & A

All Rights Reserved, Duke Medicine 2007 Duke Cancer Institute caBIG Implementation Strategy...

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