IXRS DATA TO INFORMED DECISION MAKING. Linda Chan-Kim October 2015

Transcription

1 IXRS DATA TO INFORMED DECISION MAKING Linda Chan-Kim October 2015

2 Table of Contents Genentech Overview EMMA Data Issues What did we do? 2 2

3 Roche Group An innovation network 3

4 South San Francisco is home to Genentech s Research and Early Development (gred) group s 2,100 employees, including 1,200 researchers and scientists Rigorous and groundbreaking science has always been at the core of what we do at Genentech. Our unique emphasis on strong basic research combined with an applied focus on translational research, has been instrumental to our success and growth Publications in 2014 Including 22 papers in Nature, Science, Cell 3,300 Publications the last 10 years 30+ Investigational medicines in gred portfolio 11 Antibody-drug conjugates in development for 8 different cancer types 785,000 Square feet dedicated to research, largest in the world #1 Employer according to Science Magazine 8 of 13 past years, always in top 3 4

5 gred Clinical Operations Leadership Slide 10 Vice President gred Clinical Operations Oncology ITGR Business Management Process Training & Management

6 Systems Operations Team - CSSIL Systems Subject Matter Experts responsible for oversight of multiple clinical study systems: Interactive Response System (IxRS) Clinical Database (EDC) Clinical Trial Management System (CTMS) Investigator Payments System (IPS) Individual protocol support for study management teams with IxRS throughout the study lifecycle. Planning Startup Conduct Close Out Guides Study Management through RFP process Responsible for IxRS Requirement Specifications Executes UAT with vendor and acts as main point of contact Ensures system integrations are enabled and functioning Manages IxRS issue resolution and system enhancement requests Supports drug shipment issues Notifies Business Manager and vendors of IxRS decommissioning 6

7 gred Portfolio Oncology Infectious Diseases Metabolism Doing now what patients need next Immunology Ophthalmology Neuroscience 7

8 Table of Contents Genentech Overview EMMA Data Issues What did we do? 8 8

9 Current State 9

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11 Study Summary View Phase II Protocol 11

12 Study Summary View Phase I 12

13 Usage Protocol 13

14 Table of Contents Genentech Overview EMMA Data Issues What did we do? 14 14

15 What IxRS Enabled Strategic Objectives Transparency Information-driven decision support KPI and milestone tracking Enable data transparency to leadership Accuracy Activation and Enrollment algorithms to measure progress and trigger mitigation strategies Assess CRO portfolio health Agility Near real time decision making Scenario planning tools (future focus) Manage study performance 15

16 Our Journey Starts 16

17 Previous Dashboards Excel spreadsheet of information Manual Entry of information EDC, CTMS and IxRS as Sources 17

18 Historic Data Issues Mixed tools to manage data by our CRO and Genentech Disparate business processes No standard definitions across study team and CRO Lack of consistent approach to dashboard outputs No Single source of truth: EDC, CTMS, CRO CTMS, IxRS etc CTMS used as a planning tool Lag time of data entry in systems 18

19 Table of Contents Genentech Overview EMMA Data Issues What did we do? 19 19

20 What metrics and KPIs? Site Activation Site Contracts Site Initiation Visits IRB/EC Approvals Regulatory Submission (HA) Enrollment Site Activation Screening Rate Enrollment Rate Screen Failure Rate 20

21 Data Sources that could be used Diagnostic Data EDC Imaging EMR epro Safety Analytes Rater IXRS Training EMR eicf ctdna EKG CTMS PK Site Payments Decision Making on Trial Designs 21

22 Our CTMS Why Not? Data Quality Business processes across organization different Definitions of data values differed Sources of data entry not in alignment Unreliable data sources Lag Time in Data Availability Data only as up-to-date as data entry teams No time sensitive driver to enter data System Limitations for Adaptive Designs Unable to handle PhI/PhII combination studies 22

23 What source did we start with? IxRS 23

24 Why IxRS? Information Availability Site Activation Enrollment Rates Real Time Site Data Usage/Entry High Data Quality Controlled Data Standards Data elements - naming convention Fit for purpose usage 24

25 What else did this require? Reliable Data Sources Governance IOC IMO/IGC Data Policies Automated Integration 25

26 Reliable Data Source Our CTMS Review Fit for purpose CTMS Planning tool or not? EDC Unblinded Subject Data Business processes CRO & Genentech Integrations What are the sources of CTMS data Inventory Management IxRS Blinded Subject Data 3 IxRS integrations Data Quality Accuracy and latency of data entry 26

27 Governance: IxRS Oversight Committee (IOC) and Information Management Office (IMO) Clinical Operations Leadership Leadership Study Management CSSIL IOC Clinical Supplies Biostatistics Clinical Data Management Vendor Management 27 27

28 Data Policies and Standards Standardized data collection modules Naming convention for common data points collected Ex: Cohort Name Intent to Treat versus Actual Limited data allowed to be updated in IxRS EDC maintains the source of truth for our clinical data IxRS is source of intended information Fit for purpose usage 28

29 IxRS to Centralized Data Warehouse Business Need Historical data needs versus availability Requirements Build Evaluating study trends and data collection habits Internal infrastructure requirements to support IxRS Vendor Collaboration Infrastructure requirements and build 29

30 Automated Integration to the Single Source of Truth IxRS Blinded Patient Data Data Warehouse Sources of Truth

31 Lessons Learned Need thorough understanding of complex ecosystems Validate source of data as the truth Data Profiling and Data Quality processes needed Alignment of business processes across stakeholders 31

32 Summary Organizational need for single source of truth for clinical trial data Leverage IxRS as source of information Organizational Infrastructure and Policies to support data quality of dashboard Reduce: Manual Data Entry Lag time of data availability Discrepant information 32

33 QUESTIONS?

34 Doing now what patients need next 34

35 THANK YOU Questions? Contact

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37 Automated Integration to the Source of Truth: EMMA IxRS Blinded Patient Data Data Warehouse Source of Truth 37