Rethinking Clinical Research with a Clean Slate

I7 May 2011 | Beijing, China

Wayne R. Kubick

Sr. Director, Product Strategy

Oracle Health Sciences

wayne.kubick@oracle.com

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• Old Habits Die Hard • New Habits and Opportunities of a

Blank Slate:– Using a 21st Century Technology

Infrastructure– Data Standards for Interoperability– Treating Information as a Critical Asset– The Convergence of Healthcare and Research

• Conclusions

Topics

Drug Information Association

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Old Habits Die Hard

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It is not sufficient to apply new technology to old processes

Aerospace transformation… Boeing has rapidly shifted the company to embrace a “network” of partners

Aerospace transformation… Boeing has rapidly shifted the company to embrace a “network” of partners

Partners Across the Globe Are Bringing the Boeing 787 Together

Clinical development transformation… Merck is shifting drug development toward embracing a “network” of partners

Clinical development transformation… Merck is shifting drug development toward embracing a “network” of partners

Merck External Basic Research (EBR) team expects to deliver 25% of early pipeline from external partners by 2013 (Source: Pharma Focus Asia)

The New Drug Development Paradigm

PiramalPoC Oncology Drug

Discovery

Patheon• Commercial

Manufacturing

• Pharmaceutical Dev. Services

PPD• Vaccine Testing

• Central Lab and Sample Storage

Moffitt Cancer CenterTotal Cancer Care

Advinus Candidate Drugs for Metabolic Disorders

Orchid ChemicalsBacterial and Fungal

Infection Dev

WuXi AppTecDiscovery Chemistry

RanbaxyAntifungal and Antibiotic

Target Programs

Source: Oracle Health Sciences4www.diahome.orgDrug Information Association

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New Habit: Cloud Computing

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• Faster implementation for less cost and bother• Rapid scalability • Ability to support multiple devices• But real pay-off will be when we can cross-use shared data

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Old Habit: Paper CRF Process

Query Report Form

Primary Investigator

Source Document

CRC

CRFs

SiteSponsor

Query Report Form

CDM

Edit checksGenerate QueriesPrint Query Report Form

Query System DB

CRFs

DB1

DB2

Double Data Entry

Master ClinicalData DB

CRA

Source VerificationData Review

Source: Paul Bleicher

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New Habit: EDC Process

Site Sponsor

CRA

SourceVerification

Primary Investigator

Source Document

CRC

CRFs

• Run edit checks upon entry• Resolve queries immediately • Create edit checks

• Data Review• Enter queries manually

CDM

• Data Review• Enter queries manually

CRA

Master ClinicalData DB

AppServer

WebServer

Internet

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• Old Habits: – Author each protocol as an individual text document– Collect data on paper source documents and CRFs

• New Habits: Begin with the end in mind– Structured protocol drives EDC system setup and

analysis plans– Standard metadata represented in a clinical data

warehouse

• Collect data electronically at source– Avoid transcription

• Always use common data standards

Begin with the End in Mind:Data Standards for Interoperability

Drug Information Association

Old Habit: Data Silos for Each Study

• Disparate workflows, systems and views• No holistic view of studies or clinical program• Inability to combine data across studies

Randomization

Drug Mgmt.

Study Tracking

Regulatory

Documents

Management

Clinical

Data

Capture

Data

Management

Clean Database

Patient Recruitment25%

Administration &Data Handling

75%

Workflow 1 Workflow 2 Workflow 3 Workflow 4

Investigative

Site

Source: Jagath Wanninayake

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Old Habit: Disposable Data

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Standards-based Metadata Repository

and Data Warehouse Promotes Re-use

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New Habit: Data Standards for Reuse

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• Standards-based data promotes pooling,Comparison and reuse• Collect once, use many times• Treat all research data as a critical asset

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The Convergence of Healthcare and Clinical Research

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HEALTHCARELIFE SCIENCES

“Trial and Error”Healthcare

“Evidence Based” Healthcare

“Precision”Healthcare

TargetedTherapies

Increased regulation and

efficacy standards

Analytics

LIFE SCIENCES HEALTHCARE

DNA chemistry and advanced

technology

“Managed” Healthcare

Paper based Records

Electronic Data Capture

Pharmacovigilanceand Risk Mgmt

Safety atPoint of Care

Electronic Medical Records

Paper basedSystems

Personalized Healthcare

Patient Care and Disease Mgmt

Translational Med

Blockbusters and mass-production of

novel drugs

Source: Oracle Health Sciences

ConsumersHealthcareHealth Science Cloud

Gaining Control of Healthcare Data

Providers

Life Science

Payers

Standards Bodies

Academic Research

Public Health Orgs

Regulatory Agencies

Standards Bodies

Investment Firms

Health Consumerism

ProviderNetwork

Provider

Provider

Provider

ProviderNetwork

AppExchange

Healthcare Data Model

ControlledAnalytics

CatalogMgmt

RequestWorkflow

Catalog

ContentEnrichment

PublicData

Some provider functions move from enterprise to market, e.g.

IRB workflow, Patient consent, common licensing practices

De-identified

Consented

Conformed

Controlled Cloud Accessible

Liquid & Licensed

13www.diahome.orgDrug Information AssociationSource: Oracle Health Sciences

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Linking Healthcare & Research

Case Report Form

EHR

Clinical Research

Quality Public Health

Quality MeasureOutbreak Report

Standards Used:

CDISC Structured Protocol ModelCDASH forms with ODM TransportRetrieve Protocol for Execution (RPE) ProfileRetrieve From for Data Capture (RFD) ProfileCDISC ODM Standard messaging and archive

RFDRFD RFD

Safety

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Source: Landen Bain, CDISC

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New Habit: Control & Reuse Data

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• China has a rare opportunity to look forward, rather than back, by applying new technologies to its rapidly growing clinical research and development activities

• Some principal opportunities include:– Build a 21st century IT infrastructure: use shared resources in

the cloud and mobile technologies.– Become digital – avoid paper wherever possible– Embrace standards to enable interoperability and reuse– Treat all research information as a valued asset – gain control of

healthcare/research data from the beginning– Bet on the convergence of healthcare and research

• To realize the vision, we will need collaboration and support among sponsors, regulators and vendors.

Conclusions

Drug Information Association

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Rethinking Clinical Research with a Clean Slate: Bad Habits or New?

Drug Information Association

“The fundamental difference between a dog and a human being is simple: When you point with your finger, the dog looks at the tip.”

--Nicholas Negroponte

Rethinking Clinical Research with a Clean Slate

Thank you.

wayne.kubick@oracle.com