CDISC - Mapping New Pathways for Novartis. Darren Weston, Project Leader Pat Majcher, Senior Principal Programmer

Transcription

1 CDISC - Mapping New Pathways for Novartis Darren Weston, Project Leader Pat Majcher, Senior Principal Programmer Shuhong hong Xie, Senior Statistical Programmer

2 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 2 A Novartis CDISC Story Business Use Only

3 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 3 A Novartis CDISC Story Business Use Only

4 What was the challenge? What was required? Request received: Submit the data for study x in CDISC format. If you are unable to submit in CDISC format, contact the project manager to discuss an alternative format and content of datasets Open questions generated: What exactly is CDISC format? Interpretation was required. Did this extend to the other studies in the NDA? Novartis were proactive in clarifying the expectation: Novartis Question: In addition to the raw and derived data sets, we propose to submit mapped SDTM data sets for studies a, b, c and d. Does the agency agree? FDA response: We agree 4 A Novartis CDISC Story Business Use Only

5 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 5 A Novartis CDISC Story Business Use Only

6 Novartis CDISC experience prior to this project Working groups and submission i experience Active internal CDISC strategy teams looking into SDTM and ADaM Internal teams looking into future system architecture updates Sample submissions i Novartis had provided two samples to FDA s Office of Business Process Support - Test internal tools and processes - Identify any potential issues prior to official SDTM submissions - Gain familiarity with tools used by FDA (e.g., WebSDM, Web Submission Data Manager) 6 A Novartis CDISC Story Business Use Only

7 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 7 A Novartis CDISC Story Business Use Only

8 What was delivered? From a CDISC perspective p the NDA package consisted of: STDM data sets and define.xml files for four studies Detailed mapping documentation was delivered for each study to ensure it was transparent how we mapped to the SDTM structure From a non-cdisc perspective p (relating to the four studies) CRTs (define.pdf containing CRFs, raw and derived data sets, and data handling documents) for each of the four studies Primary efficacy programs for each of the four studies (note: programs were based on non-sdtm data sets) 8 A Novartis CDISC Story Business Use Only

9 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 9 A Novartis CDISC Story Business Use Only

10 What was the execution strategy? Resourcing strategy t Internal CDISC expert assigned from the US team as a lead Programmers assigned from global sites (US and India) to map the data Contract t with external vendor set up to: Leverage external expertise Build the define.xml files for the studies Verify that the data sets conform to the SDTM standard using the WebSDM application (as used by FDA) 10 A Novartis CDISC Story Business Use Only

11 What was the execution strategy? Mapping strategy t Decision was taken to utilise an internal SAS macro based tool Mapping team were thoroughly trained on: SDTM Internal SDTM mapping tool Next step was to review the previous submission mapping experiences Assessments were made regarding what could be re-used and what had to be programmed from scratch Formal review and assessment of the non-standard safety and efficacy domains 11 A Novartis CDISC Story Business Use Only

12 What was the execution strategy? Operational strategy t Domains were assigned to individual programmers To promote consistency in the domains across the studies Increase the efficiency across the studies Weekly mapping forums to discuss issues Regular meetings with external vendor to discuss the reports coming from WebSDM 12 A Novartis CDISC Story Business Use Only

13 Agenda What was the challenge? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 13 A Novartis CDISC Story Business Use Only

14 What were the challenges? External workflow challenges Mapped data sets sent to external vendor Excel issues log from WebSDM sent to Novartis Process worked well but some issues were not real issues or had been previously addressed, but appeared with each report These had to be logged to aid an efficient review External vendor was very responsive to issues and overall the partnership worked well 14 A Novartis CDISC Story Business Use Only

15 What were the challenges? Mapping challenges SDTM implementation guide issues Non-standard safety domains and some efficacy domains were not clearly defined in the implementation guide The team had to interpret what to do Implementation guidelines were sometimes too flexible and open to interpretation Team support challenges Mechanism had to be in place to support the multiple questions expected from the team due to the steep learning curve As the team was globally spread, associates were flexible with their working hours to increase the available time window between two regions 15 A Novartis CDISC Story Business Use Only

16 What were the challenges? File size challenges Supplemental qualifier was extremely large (>5GB) due to the non-standard data stored in a highly vertical structure In the pre-nda minutes, FDA had specified that there was no requirement to split data sets WebSDM initially iti struggled with this file size and required a memory upgrade Internal systems required transport files to be split. These were combined by the external vendor when delivered as part of the define.xml 16 A Novartis CDISC Story Business Use Only

17 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 17 A Novartis CDISC Story Business Use Only

18 Novartis future CDISC plans This interim mapping approach helped increase Novartis experience with data conversion and submission tools and processes, as well as the associated metadata Novartis is now approaching the challenge of implementing CDISC standards via several distinct but overlapping efforts 18 A Novartis CDISC Story Business Use Only

19 Novartis future CDISC plans Novartis have initiated multiple projects to address different aspects of data standards Projects are coordinated through a high-level program, with appropriate management support Key internal stakeholders have been identified and there is appropriate representation across the projects Partnerships with external consultants and technology vendors have been set-up Non-technical areas requiring attention have been identified and teams set-up to address these areas e.g. change management, training, etc. 19 A Novartis CDISC Story Business Use Only

20 Novartis future CDISC plans Project application landscape Site/ Local Countries Remote Data Capture (Oracle RDC) 3rd Party Data Thesaurus Mgt System (Oracle TMS) Clinical Data Management System (Oracle Clinical) Novartis Clinical Data Warehouse (Oracle LSH) Data Pooling, Analysis & Reporting Modeling & Simulation and Data Mining Submission & Safety Reporting Regulator/ External CRO EDC CROs Data Conversion Factory Legacy Clinical Database Clinical Data Standards Definition and Governance 20 A Novartis CDISC Story Business Use Only

21 Agenda What was the submission request? Novartis CDISC experience prior to this project What was delivered? What was the execution strategy? What were the challenges? Novartis future CDISC plans Q&A 21 A Novartis CDISC Story Business Use Only

22 Q&A Any questions? 22 A Novartis CDISC Story Business Use Only