1. Midwest Biopharmaceutical Statistics Workshop
Dynamic SMQ Search for Safety Signal Detection Using Spotfire
Xiangyun Wang, Statistical Programming and Analysis
Roland Morley & Chen Huang, PD Drug Safety
Genentech, Inc.
5/23/2017

2. Disclaimer
All numbers shared in the presentation are based on dummy data. No clinical interpretation should be drawn based on the presentation.

3. Outlines Background and Objectives Implementation Considerations
Dynamic SMQ Search Interface in Spotfire
Example Use Case + Demo
Summary and Next Step

5. Smart Together

6. The Request from Safety Scientists
Can we have an interactive approach to SMQ search for ongoing safety signal detection?

7. The Challenges Current challenges for safety signal detection
Manual review with non-standardised groups of terms
 prone to error
Cross-functional programming support of data retrieval
 time consuming with back-and-forth change requests and communication.
How to provide a powerful, user-friendly platform to enable effective SMQ search becomes vital in supporting real-time safety signal monitoring in pharmacovigilance

8. What is SMQ?
Standardised MedDRA Queries (SMQs) are groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest.
SMQ use is recommended as the powerful search strategy to retrieve potential cases of interest for early detection and evaluation of emerging safety signals in clinical development.

9. Our Approach
Goal
Empower safety scientists to conduct self-service based on any SMQ(s) of interest for emerging signal detection
What
Develop an interactive data exploration tool using Spotfire
Automate update of all industry SMQs to be consistent with MedDRA version
Enable near real-time signal detection with regular data refresh for clinical data via Information Link

10. Why Spotfire?
Ease of use for end-users with its dynamic and flexibility features
Stakeholders’ familiarity with the tool
Company’s existing Spotfire infrastructure and support team
We chose Spotfire as the collaboration tool not only because of its easy-of-use with interactive and dynamic features, but also because of our existing Spotfire infrastructure and stakeholders’ familiarity with the tool.

11. Implementation Considerations

12. Database Configuration
Master SMQ
SMQ ID
Preferred Name
Description
SMQ Version
Study ID
Subject ID
MedDRA Coded Term
MedDRA Version …
ADaM AE

13. SMQ Search Interface in Spotfire
Flexibility of search by any SMQ(s)
Instantaneously review of summary results
Script to help reveal underlying filtered data to ensure accuracy
Further exploration capability via filtering
Corresponding preferred terms for the SMQ
Drill-down into individual patient-level data

14. Example Use Case What How
Leverage ISS Visualization Suite to Support Drug Safety Report (DSR) for Acute Kidney Injury (AKI)
How
Safety scientists conducted self-exploratory analysis using Acute Renal Failure (wide SMQ)
Explore and review subgroup analysis results as needed
Work with Biometrics/programming group to finalize analysis to ensure quality and reproducibility

15. AKI DSR: How the SMQ Search Tool Helped?
Safety Scientist leveraged the SMQ search tool to explore many subgroup analysis (~60 outputs)
Subset by seriousness, relationship to study drug, standard toxicity grade,
Grouping by indication, study treatment, study …
Only 12 visualization results needed for final reporting and archiving 
List of final outputs with bookmark links in Spotfire:

16. Summary of Patients with All AKI Relevant AEs

17. Summary of Patients with AKI Relevant AEs Leading to Drug Withdrawn

18. Summary of Patients with AKI Relevant Serious AEs

19. Patient Profile
© 2014 DIA, Inc. All rights reserved.

20. Demo: Dynamic SMQ Search using Spotfire

21. Benefit Highlights
Reproducible signal detection with industry standard baskets of terms
Agility with self-service exploration
Effectiveness with quick data insights
Efficiency gain with time and resource saving

22. Further Exploration
Additional capabilities for safety signal detection:
Multiaxiality issue (MedDRA dictionary for secondary paths)
Customized search algorithm (e.g. modified SMQ or AE group terms)
Streamline the work flow to support from real-time ongoing safety surveillance to decision-making (i.e., compliance considerations)