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The Evolution of Risk-Based Monitoring in Clinical Trials

Explore the development and implementation of Risk-Based Monitoring (RBM) in clinical trials, its impact on trial complexity, and considerations for sites and stakeholders. Join Dr. Darina Hrdličková at the EM Phases Conference in Prague, October 2018.

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The Evolution of Risk-Based Monitoring in Clinical Trials

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  1. Risk Based Monitoring IsHere To Stay EM PhasesConference Prague Oct 2018 Dr. Darina Hrdličková

  2. Developmentof monitoring 1990s100% SDVAttention to detailA small team – CRA and PA2010…..Remote monitoring (not risk based!)Teamsgrow - CRA, PA, Remotemonitors… DHRBM 2018 2

  3. Trial complexity is increasing Growing clinical trial complexity continues to challenge the ability of companies to support thecosts of new drug development Where are wegoing? How do wecontinue? Theconceptof Risk-Based Monitoring (RBM): FDA draft 2011, final August 2013 EMA November 2013 ICHGCP E 6 (R2) 2016 DH RBM 2018 3

  4. DevelopmentofRBM 2013 …..Risk-based monitoringVariousapproachesTeamsgrowfurhter Always: Central data analytics Lessthan 100% SDV Remote and onsite monitoring Cross-functionalapproach DH RBM 2018 4

  5. RBM Protocolevaluation: Monitoring Plan: Risk identification Source Data Verification Risk assessmentPROACTIVESource Data Review Risk documentation Central Data Analytics: Monitors: (Onsite, Remote) Risk indicatorsEventTriggered Monitoring Outliers, TrendsRoot Cause Analysis CorrectiveActions Project Management: Risk management COMMUNICATION! Risk mitigationDOCUMENTATION! MULTIPLESTAKEHOLDERS DH RBM 2018 5

  6. And WhatAbouttheSites ? Acceptance? Communicationwithmultiplepartners? Requirementsforequipment Requirementsforspace: archiving, monitoring Requirementsforpersonnel Administrativeburdenconstantlyincreasing Needtechnical/computerskills – multiplesystems Need a lot oftime DHRBM 2018 6

  7. ???????????????????????????????????????????????????? Thankyouforyourattention ! DHRBM 2018 i 7

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