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Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
Just in-time-clinical-trial-monitoring
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Just in-time-clinical-trial-monitoring

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Improved technology adoption and clinical operations processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing …

Improved technology adoption and clinical operations processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time Monitoring that is dramatically changing the way we interact with our trial sites.

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  • Remote monitoring permits CRAs to know what they are looking for on site. They have already identified trends and are knowledgeable about repetitive errors. This facilitates more timely corrective action.Check for excluded medications or medical conditionsCross-reference concomitant medication indications for use against medical history/AE dataLook at any medications or medical history information with an onset that occurs after randomization to probe for unreported AesLook for deviations (randomization issues, out of window visits, etc.)Filter for blanks (omitted data)Tools and technology promote compliance by design. System format leads sites to enter all available data relevant to the protocol. Transparency allows monitors to determine whether Adverse Events need to be captured, etc. System facilitates proactive resolution of issues.
  • Transcript

    • 1. 5 key reasons to make the move to Just-in-Time Monitoring
      Carla Radke, BS, RN, CCRP
      Laurin Mancour, CCRA, CCRP, RAC
      Mark Shapiro, MA, MBA, CCRA, RAC
      February 24, 2010
    • 2. Today’s webcast will cover
      Our goal today is to discuss what Just-in-time Monitoring is and how it can help:
    • 3. Why are we here?
      Clinical trials are complex [and expensive], and good monitoring can positively impact on site performance, timeline, and budget.
      Study Start-up
      Study Analysis
      Study Planning
      Study Reporting
      Study Execution
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      Moving to Just-in-Time Monitoring can make a significant impact on study execution
    • 4. What is Just-in-Time Monitoring?
      Just-in-Time monitoring is changing the paradigm for monitoring visit frequency from an elapsed duration (monitor the site every eight weeks) to an event-driven paradigm (monitor the site after the first and every third subject is enrolled or in the event of a protocol deviation). 
       
      Just-in-Time monitoring is only possible with the use of EDC and the corresponding ability of CRAs to monitor the sites remotely (review enrollment, subject data, and queries) on a regular basis. 
    • 5. Detecting and addressing problems early
      Just-in-Time monitoring helps to keep trials on track and reduce or mitigate certain trial risks. It can impact many trial metrics.
    • 6. Strengthening relationships with trial sites
      Just-in-Time monitoring is a vehicle to change the nature of the monitor-site relationship
      First, focus on well-performing sites
      They will get you your patients and they will appreciate your support
      Just-in-Time Monitoring is
      Less disruptive to site’s clinical activities and obligations
      Proactively identify issues and change behaviors, prior to the visit
      Consistent communication with sites and greater support
      More and more monitoring activities can be done remotely and be less disruptive to the site
    • 7. Focusing on Ethics and Regulatory Compliance
      With Just-in-Time Monitoring, more site time can be spent ensuring the trial is ethically executed and appropriately-documented.
      Transparent access to study data enables monitors to identify issues, prior to study visits
      Focus on more complex protocol-related issues and deviations
      Increased time available for ethical and regulatory compliance reviews
      Increased time available for site training and re-training
      Tools and technology promote compliance by design
      Edit checks promote protocol adherence
      Reports allow you to identify deviations and ensure proper AE reporting
    • 8. Avoiding CRA stress and burnout
      #1 Reason CRA’s say they quit their job? TOO MUCH TRAVEL
      More site transparency = less travel = happier monitors
      Happier monitors = less employee turnover
      Remote data monitoring permits less rushing, on-site
      Faster source document verification when on-site
      Reduces the number of queries and protocol deviations
      Learning curve for each new protocol
      Supported by a database that accounts for subject selection criteria that anticipates outliers as potential deviations
    • 9. Let’s run the numbers, reducing trial costs
      Consider the following hypothetical Phase II study scenario:
    • 10. Initiate early to enroll more
      As would be expected in a competitive enrollment study, sites that were initiated early enrolled more subjects.
    • 11. This graph shows the total number of hours required to monitor all subjects at each site under the three monitoring paradigms.
      Capacity more closely aligned to enrollment
    • 12. Stop over monitoringpoorly enrolling sites
      Scheduling monitoring based on elapsed time (q4 or q6 weeks) leads to less efficient deployment of resources than JIT monitoring at lower enrolling sites.
    • 13. Efficiency creates capacity
    • 14. Q&A
      CLINIPACE.COM
      Carla S. Radke {cradke@clinipace.com}
      Laurin Mancour {lmancour@clinipace.com}
      Mark Shapiro {mshapiro@clinipace.com}

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