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  • Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials
    • Risk Based Monitoring for Central Nervous System (CNS) Clinical Trials

    • Presenters: Gerard Conway, Michael Phillips , Company: PerkinElmer Informatics, ICON plc
    • Duration: 60 min
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  • Risk based monitoring is now fully supported as a method to optimize clinical trial operations and monitoring by the Food and Drug Administration, European Medicines Agency and Pharmaceuticals and Medical Devices Agency. In this webinar, learn how you can shift clinical monitoring, for central nervous system clinical trials, from frequency-based to proactive, comprehensive risk based monitoring.

    Central nervous system clinical trials have a relatively poor success rate, not least because it is difficult to measure their clinical endpoints. Clinical outcome assessments (COAs or scales), and particularly clinician-reported outcomes (ClinROs), are often selected as primary outcome measures in CNS clinical trials. However, a small number of errors in these somewhat subjective instruments can profoundly affect study results.

    As such, a standard analytics template for the central risk based monitoring of CNS clinical trials has been built using Spotfire’s uniquely accessible API (application programming interface). Using three key risk indicator (KRI) themes, a standardized clinical data model, a scales rule “engine,” and interactive visualizations, a flexible analytics template has been built with the capability of deploying any CNS indication for any set of scales and with study-specific KRIs. The scales rule engine is a self-service analytics tool, accommodating complex scale summation rules and study-specific KRI requirements without any need for additional programming or template.

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