Rethinking Clinical Research with a Clean Slate

Transcription

1 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

2 Topics Old Habits Die Hard New Habits and Opportunities of a Blank Slate: Using a 21 st Century Technology Infrastructure Data Standards for Interoperability Treating Information as a Critical Asset The Convergence of Healthcare and Research Conclusions Drug Information Association 2

3 Old Habits Die Hard It is not sufficient to apply new technology to old processes Drug Information Association 3

4 The New Drug Development Paradigm Aerospace Clinical development transformation transformation Boeing Merck is has shifting rapidly drug shifted development the company toward embrace embracing a a network of of partners Piramal PoC Oncology Drug Discovery WuXi AppTec Discovery Chemistry Ranbaxy Antifungal and Antibiotic Target Programs PPD Vaccine Testing Central Lab and Sample Storage Patheon Commercial Manufacturing Pharmaceutical Dev. Services Orchid Chemicals Bacterial and Fungal Infection Dev Moffitt Cancer Center Total Cancer Care Advinus Candidate Drugs for Metabolic Disorders Partners Merck External Across Basic the Globe Research Are Bringing (EBR) team the expects Boeing 787 to deliver Together 25% of early pipeline from external partners by 2013 (Source: Pharma Focus Asia) Drug Information Association Source: Oracle Health Sciences 4

5 New Habit: Cloud Computing 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 Drug Information Association 5

6 Old Habit: Paper CRF Process Source Document CRFs CRFs Primary Investigator CRC Double Data Entry DB1 Source Verification Data Review Query Report Form DB2 Master Clinical Data DB CRA Edit checks Generate Queries Print Query Report Form CDM Site Sponsor Query Report Form Query System DB 6 Source: Paul Bleicher

7 New Habit: EDC Process Source Document CRFs Primary Investigator Source Verification CRC Run edit checks upon entry Resolve queries immediately Web Server App Server Master Clinical Data DB Create edit checks Data Review Enter queries manually CDM CRA Internet Data Review Enter queries manually CRA Site Sponsor 7

8 Begin with the End in Mind: Data Standards for Interoperability 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 Drug Information Association 8

9 Old Habit: Data Silos for Each Study Administration & Data Handling 75% Investigative Site Patient Recruitment 25% Workflow 1 Workflow 2 Workflow 3 Workflow 4 Regulatory Documents Management Clinical Data Capture Data Management Randomization Drug Mgmt. Study Tracking Disparate workflows, systems and views No holistic view of studies or clinical program Inability to combine data across studies Drug Information Association Clean Database Source: Jagath Wanninayake 9

10 Old Habit: Disposable Data Standards-based Metadata Repository and Data Warehouse Promotes Re-use Drug Information Association 10

11 New Habit: Data Standards for Reuse Standards-based data promotes pooling, Comparison and reuse Collect once, use many times Treat all research data as a critical asset Drug Information Association 11

12 The Convergence of Healthcare and Clinical Research Personalized Healthcare Translational Med Targeted Therapies DNA chemistry and advanced technology Patient Care and Disease Mgmt Analytics Precision Healthcare Evidence Based Healthcare Blockbusters and mass-production of novel drugs Increased regulation and efficacy standards Paper based Records Pharmacovigilance and Risk Mgmt Electronic Data Capture Safety at Point of Care Electronic Medical Records Paper based Systems Managed Healthcare Trial and Error Healthcare LIFE LIFE SCIENCES HEALTHCARE Source: Oracle Health Sciences Drug Information Association 12

13 Gaining Control of Healthcare Data Healthcare Consumers Health Science Cloud Catalog Mgmt Public Data Catalog Controlled Analytics Liquid & Controlled Licensed Conformed Cloud Accessible Consented De-identified Request Workflow Content Enrichment App Exchange Some provider functions move from enterprise to market, e.g. IRB workflow, Patient consent, common licensing practices Drug Information Association Source: Oracle Health Sciences 13

14 Linking Healthcare & Research Public Health Safety Clinical Research Case Report Form Quality RFD Outbreak Report RFD Quality Measure RFD Source: Landen Bain, CDISC EHR Standards Used: CDISC Structured Protocol Model CDASH forms with ODM Transport Retrieve Protocol for Execution (RPE) Profile Retrieve From for Data Capture (RFD) Profile CDISC ODM Standard messaging and archive 14 Drug Information Association 14

15 New Habit: Control & Reuse Data Drug Information Association 15

16 Conclusions 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 21 st 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. Drug Information Association 16

17 Rethinking Clinical Research with a Clean Slate: Bad Habits or New? 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 Drug Information Association 17

18 Rethinking Clinical Research with a Clean Slate Thank you. wayne.kubick@oracle.com