How are safety analyses different from efficacy analyses?
What does validation and quality control mean for interactive visualization?

Over recent years, a lot of interesting things happened around safety analyses and visualization. They help us to better understand our safety data and detect safety signals. Wei and colleagues have recently published an article about these topics.

In today’s episode, Wei and I dive deep into the future of safety analyses and discuss the following topics:
  • For interactive tools – how can we achieve traceability of what we looked at demonstrating transparency on the decision process in an interactive tool?
  • What are your experiences in developing an interactive tool?
  • What are the best practices for data visualizations for safety?
  • How can we give external parties like the FDA access to such tools?

Reference:

  • Biopharmreport, 2020 winter issue (publicly available)
  • Clinical Trial Drug Safety Assessment With Interactive Visual Analytics,  STATISTICS IN BIOPHARMACEUTICAL RESEARCH 2020, VOL. 00,NO. 0, 1–12 DOI
  • Amit, Ohad, Richard Heiberger, and Peter Lane. 2008. “Graphical approaches to the analysis of safety data from clinical trials.” Pharmaceutical Statistics no. 7:20-35.
  • Clinical Trials Safety Graphics Working Group. Clinical trials safety graphics home page 2013. Available here.
  • Duke, Susan P, Fabrice Bancken, Brenda Crowe, Mat Soukup, Taxiarchis Botsis, and Richard Forshee. 2015. “Seeing is believing: good graphic design principles for medical research.” Statistics in medicine no. 34 (22):3040-3059.
  • Forrest Stroud. Containerization. Available here.
  • Friedman, Lawrence M., Curt D. Furberg, and David L. DeMets. 2012. Fundamentals of Clinical Trials. New York: Springer.
  • Hepatic Safety Explorer. Available here.
  • PHUSE Adverse Events White Paper Team. 2017. Analysis and displays associated with adverse events: Focus on adverse events in phase 2-4 clinical trials and integrated summary documents. Available here.
  • PHUSE Oct. Webinar Recording. Sharing an Interactive Display in an FDA Submission Pilot 2019. Available here.
  • PHUSE Oct. Webinar Slides. Sharing an Interactive Display in an FDA Submission Pilot 2019.  PHUSE Working Group. Available here.
  • PHUSE Workshop. Safety Analytics Workshop 2019. Available from https://www.phuse.eu/documents/working-groups/deliverables/safetyanalyticsworkshop-PHUSEcss2019-21959.pptx 
  • Rosario, Lilliam A, Timothy J Kropp, Stephen E Wilson, and Charles K Cooper. 2012. “Join FDA/PhUSE working groups to help harness the power of computational science.” Drug Information Journal no. 46 (5):523-524.
  • Safety Explorer Suite. Available here.
  • Singh, Sonal, and Yoon K Loke. 2012. “Drug safety assessment in clinical trials: methodological challenges and opportunities.” Trials no. 13 (1):138.
  • U.S. Food and Drug Administration. 2010. Good review practice: Clinical review template. Manual of policies and procedures. Available here.
  • Wildfire, Jeremy, Ryan Bailey, Rebecca Z Krouse, Spencer Childress, Britt Sikora, Nathan Bryant, Shane Rosanbalm, Emily Wilson, and Jack G Modell. 2018. “The safety explorer suite: interactive safety monitoring for clinical trials.” Therapeutic Innovation & regulatory science no. 52 (6):696-700. 

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Wei Wang

Wei Wang is a statistician in the Safety Analytics team. She has been with Lilly for over 20 years. She has worked in various therapeutic areas, including, Autoimmune, Neuroscience, Man’s health. Over the past 10 years, Wei has led various initiatives in the Safety Analytics area in Lilly. She has a special interest in visual analytics and has led a number of innovation efforts in this area. She is also a subject matter expert in laboratory analysis and display and is currently chairing the Lab Community in Lilly. Wei has a master degree in biostatistics from University of Hawaii. She was a medical doctor in China and practiced medicine for five years.

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