SAS Drug Development User Connections Conference 23-24Jan08

Transcription

1 SAS Drug Development User Connections Conference 23-24Jan08 Bernd Doetzkies David Ramage Daiichi Sankyo Pharma Development

2 DSPD Clinical Data Repository System Business Drivers System Overview People and Process Success Stories Future Directions & Challenges page 2

3 Business Drivers Data on Demand On-demand access to information for rapid decision making Accelerated, accurate data flows, reviews, analyses, and outputs in a regulatory compliant environment Technology that is transparent to the users Globally accessible page 3

4 Daiichi Sankyo Phase 1 Business Objectives Data Capture Integrate Systems Used to Collect Clinical Trial Data Electronic Data Capture (EDC) Laboratory Data Pharmacokinetic Data ECG Data CRO Clinical Data Management Systems (paper-based studies) page 4

5 Daiichi Sankyo Phase 1 Business Objectives Data Capture Data Storage Centralized Repository Regulatory Compliant Secure Data Transfers Database Security Scalable page 5

6 Daiichi Sankyo Phase 1 Business Objectives Data Capture Storage Data Retrieval Retrieve Data in a Structured Manner Support On-going Data Review Non-programmer Access to Data Access to Meta Data Database Locking Medical Coding page 6

7 Daiichi Sankyo Phase 1 Business Objectives Data Capture Storage Retrieval Analysis Validated System for Statistical Analysis SAS Environment to Manage Analysis Output Potential to Integrate Other Analytical Tools page 7

8 Daiichi Sankyo Phase 1 Business Objectives Data Capture Storage Retrieval Analysis Reporting Validated System for Generating Tables, Listings, Figures (TLFs) SAS Environment to Manage TLF Output Provide Secure Access to TLF Output page 8

9 System Overview Patient Diary Data Lab Data PK Data ECG Data EDC Data DSPD EDC Studies Paper-Based Studies (CDMS) CRO DSPD Clinical Data Repository Vendors & Consultants Data Browsing Safety Reviews Data Listings Medical Coding Analysis Datasets Tables Listings Figures page 9

10 System Overview Data Capture Storage Retrieval Analysis Reporting Streamlined the process of capturing data at sites Put in place a process for data exchange with multiple data and service providers Facilitate the process of data integration Data on-demand for review, analysis, and reporting Eliminated the need to implement a traditional Clinical Data Management System at DSPD page 10

11 System Overview SDD is the cornerstone of a suite of clinical solutions hosted at SAS that make up the DSPD Clinical Data Repository SAS Drug Development Internet Accessible SAS Hosting page 11 ICS JReview Cerner-Galt dsnavigator

12 SAS Drug Development Unstructured Data User Interface System Overview SDD SAS Programs Clinical Trial Data Tables, Listings, Figures page 12

13 SAS Drug Development Files UI SDD System Overview SAS Pgms Datasets TLFs dsnavigator User Interface Dictionary Management System Interface dsnav IAT page 13 MedDRA WHODD Medical Coding

14 System Overview SAS Drug Development JReview UI SDD Files Data Browsing and Reporting Tool SAS Pgms User Interface dsnavigator UI dsnav Datasets Dictionary Management TLFs System Interface IAT JR page 14 MedDRA WHODD Medical Coding Safety Monitoring Reports

15 People and Processes Background Information In production since November active user accounts Approximately 50% DSPD / Vendor users Users based in US / EU / Japan Currently in the process of upgrading from SDD 3.0 / JR 8.0 / dsnav 3.1 to SDD 3.4 / JR 9.0 / dsnav 3.2 page 15

16 People and Processes Storage Retrieval Data & Service Providers Use My Network Places to establish a Web Folders connection to SDD User account and password are required No software downloads are required - very important for vendors with validated systems Data & service providers transfer and retrieve data, files, reports, etc. in SDD via HTTPS page 16

17 People and Processes Data Management Storage Retrieval Control structural changes to datasets Web Folders support in v.3.4 Use SDD Data Definition Explorer to confirm dataset structures Opportunity to improve user friendliness Implemented a process & programs to confirm dataset structures Developed SAS programs to answer the management question: So, how CDISC compliant are our databases? page 17

18 SDD Data Structure Template.xls Project Data Manager (PDM) CRO Data Structure Template.xls Customized by CRO domains.xls SDD Admin domains.sas7bdat SDD Admin Data Specifications.xls combined.xls Advanced Loader combined.sas7bdat mk_studydsets.sas Transfer into SDD Data Specifications.xls Domains.xls Combined.xls Data structure template.xls is customized by CRO to produce data specifications. The metadata are extracted from the data specifications by Excel macros into two Excel files 1) domains.xls and 2) combined.xls Mock Datasets PDM SAS Datasets cktransfer.sas Transfer into SDD SAS Datasets Domains.xls contains metadata for domain name, domain label and specified sort order Combined.xls contains metadata for variable name, label, type, length and controlled terminology

19 page 19 Programmatically Comparing Data Libraries Stephen Hamburg, Omnicare Clinical Research, King of Prussia, PA

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22 People and Processes Clinical Team Members Retrieval Analysis SDD & JR for ongoing data review Clinical Development Risk Management and Pharmacovigilance Data Management Biostatistics Translational Medicine and Clinical Pharmacology Project Management page 22

23 People and Processes Clinical Team Members Retrieval Analysis page 23

24 People and Processes Clinical Team Members Retrieval Analysis Actual lab test results by subject and by visit displayed with Mean & Median by subject across visits. page 24

25 People and Processes Clinical Team Members Retrieval Analysis page 25

26 People and Processes Clinical Team Members Retrieval Analysis page 26

27 People and Processes Clinical Team Members Retrieval Analysis page 27

28 People and Processes Clinical Team Members Retrieval Analysis Select Create page 28

29 People and Processes Retrieval Analysis Reporting Biostatistics/Programming page 29

30 Success Stories Data on Demand & Collaboration CRO (UK) loads up-to-the-minute AE information & study datasets by cohort Medical monitors and project team members in the UK & US review AE data Vendor loads PK results per cohort DSPD Clinical Data Repository TMCP Sr. Scientist analyzes PK results and posts preliminary results Project team members in the UK & US review preliminary PK results & study data by cohort for dose escalation decision making page 30

31 Success Stories Data on Demand & Collaboration CRO (US) loads study datasets for project team review and analysis DSPD project team members in US review study datasets Vendor loads PK results DSPD Clinical Data Repository Consultant analyzes PK and study data and loads results Project team members in the US review PK analysis results page 31

32 Success Stories Data on Demand & Collaboration Risk Management / Pharmacovigilance Request summary report on AEs by System Organ Class and Preferred Terms by study and across studies. CRO Requires SOW, additional funding, additional time. Request withdrawn. Data Operations able to generate report via JReview and SDD ~1 hour DSPD Clinical Data Repository page 32

33 Success Stories Data on Demand & Collaboration CROs load study datasets for project team reviews Risk Management / Pharmacovigilance loads AE information from safety system DSPD Clinical Data Repository Project team members review all safety data for ongoing SAE reconciliation page 33

34 Future Directions & Challenges Integration of additional types of data: Micro-array ECG wave form Biomarker Genomic Images Integration with additional software applications Modeling & Simulation Applications Safety System Document Management System Submission System page 34

35 Future Directions & Challenges Data Warehousing & Mining Safety Signal Detection Modeling & Simulations Meta Analysis i.e., Effect Size Store Additional Meta Data» CDISC Protocol Representation» CDISC ADaM» CDISC Lab Plan to converge to the single, integrated CDISC Standard between now and 2010 (CDISC Roadmap) Readiness of vendors and companies to take the next step. page 35