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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. Topics. Old Habits Die Hard New Habits and Opportunities of a Blank Slate: Using a 21 st Century Technology - PowerPoint PPT Presentation
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Rethinking Clinical Research with a Clean Slate
I7 May 2011 | Beijing, China
Wayne R. KubickSr. Director, Product StrategyOracle Health Scienceswayne.kubick@oracle.com
www.diahome.org 2
• 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
www.diahome.org 3
Old Habits Die Hard
Drug Information Association
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
Partners Across the Globe Are Bringing the Boeing 787 Together
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
www.diahome.org 5
New Habit: Cloud Computing
Drug Information Association
• 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
6
Old Habit: Paper CRF Process
Query Report Form
Primary Investigator
Source Document
CRC
CRFs
Site Sponsor
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
7
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
www.diahome.org 8
• 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
RandomizationDrug Mgmt.Study Tracking
RegulatoryDocuments Management
Clinical Data Capture
DataManagement
Clean Database
Patient Recruitment25%
Administration &Data Handling
75%
Workflow 1 Workflow 2 Workflow 3 Workflow 4
InvestigativeSite
Source: Jagath Wanninayake
www.diahome.org 9Drug Information Association
www.diahome.org 10
Old Habit: Disposable Data
Drug Information Association
Standards-based Metadata Repository
and Data Warehouse Promotes Re-use
www.diahome.org 11
New Habit: Data Standards for Reuse
Drug Information Association
• Standards-based data promotes pooling,Comparison and reuse• Collect once, use many times• Treat all research data as a critical asset
www.diahome.org 12
The Convergence of Healthcare and Clinical Research
Drug Information Association
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
ConformedControlled Cloud Accessible
Liquid & Licensed
13www.diahome.orgDrug Information AssociationSource: Oracle Health Sciences
14
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
Drug Information Association www.diahome.org 14
Source: Landen Bain, CDISC
www.diahome.org 15
New Habit: Control & Reuse Data
Drug Information Association
www.diahome.org 16
• 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
www.diahome.org 17
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
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