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Top 5 Warning Signs Your Clinical Trial Is Off Track
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Top 5 Warning Signs Your Clinical Trial Is Off Track

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  • Very interesting data: there is a temporal disconnect between top cited causes and top cited preventive actions There doesn't seem to be much supporting logic to the perceived idea that improving data collection (eDC/eCRF, primarily during operations/management and after recruitment/enrollment ) would improve delays caused by perceived top reasons (mostly during study definition/setup + recruitment/enrollment). Unless, of course, there may be an implied (and unstated) assumption that the top causes are not, as well, the most impactful causes. Probably worth doing some additional research.
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  •   TEMPO – discuss how our services our built upon tempo [on click] ROLES – discuss how tempo and our services support various roles [on click] SERVICES – discuss how our services are tied to various operational research functions [on click] DESCRIPTIONS – discuss the deliverables within each service line [on click]
  • Transcript

    • 1. Mark Shapiro, MBA, RAC Director, Clinical Solutions Clinipace, Inc.
    • 2. About Clinipace Sites TEMPO PLATFORM Full-service digital clinical research organization (dCRO) Project Management Data Management Clinical Operations Design and Analysis Study Manager Investigator Biostats CRAs
    • 3. We already know www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Thomson CenterWatch 2003, 2005 survey of sites in U.S.
    • 4. Risk Management Framework
        • We define risks as potential events with a non-zero likelihood that could impact the timelines, cost, or quality of the study.
      Recognizing warning signs that a trial is off track falls into the category of Risk Measurement Risk Management: A Four-Step Process
      • Risk Assessment and Analysis:
      Work with the Sponsor to agree on potential risks to the study across all study phases and then prioritize them in terms of importance
      • Risk Mitigation:
      Put in place processes or systems to proactively reduce the likelihood that identified risks become issues
      • Risk Measurement:
      Work with the Sponsor to agree on and implement measures necessary to assess risks and determine whether they have become issues
      • Risk Management:
      Define actions to be taken in response to those risks that become issues during the course of the study.
    • 5. Study Start-Up Warning Signs to Look for…
      • CRF, database, and planning activities are driven off of a synopsis or draft protocol
      • Protocol not approved in first cycle of IRB review
      • Poor site compliance with regulatory document submissions
      • Poor Investigators’ Meeting attendance
      How to measure…
      • Close contact with central IRB
      • % of PI’s that attend the IM
      How to fix…
      • Gather site feedback on the draft protocol
      • Target key central IRB sites during start-up
      Related Challenges
      • Slower than expected enrollment
    • 6. Study Start-Up Warning Signs to Look for…
      • Target enrollment rate does not match historic rates
      • Fewer sites than expected show interest in participating in the study
      • Study coordinators raise questions or concerns about the inclusion/exclusion criteria or schedule of assessments
      • High screen-failure rate observed
      • Poor awareness of the treatment standard-of-care and /or competitive landscape (global and local)
      How to measure…
      • Use technology to measure and monitor screening, enrollment, and screen failure rates
      • Reassess enrollment expectations at the PSV and IM
      How to fix…
      • Build enthusiasm for the scientific aims of the study
      • Focus on high-performing sites
      • Facilitate learning and information-sharing across sites
      • Identify and activate back-up sites early
      Related Challenges
      • First subject, first visit is delayed
    • 7. Study Operations Early Warning Signs to Look for…
      • Breakdown of the Sponsor-CRO relationship
      • Study monitoring is poorly aligned with site enrollment
      • Protocol amendments required
      • Pass-through costs are greater than expected
      • Enrollment lags expectations
      How to measure…
      • Availability of PM or other key team members
      • On-line monitoring visit calendar
      • Analyze spending rates on invoices
      How to fix…
      • Start with a clear and comprehensive Communication and Risk management plan
      • Use remote and just-in-time monitoring
      • Validate site cost expectations before setting trial budget
      Related Warning Signs
      • Slower than expected enrollment
      • Project team turnover
    • 8. Study Operations Early Warning Signs to Look for…
      • Historic turnover rate
      • Historical delays or challenges with the program
      • Rising stars
      • Attitude and enthusiasm of the project team
      • Availability of project team members
      How to measure…
      • Ask about turnover rate and transition plans
      • Pay attention to attitude and availability
      How to fix…
      • Start with a clearly defined transition plan
      • Follow the Communication and Issue Escalation Plan
      • Manage quality of life challenges
      Related Warning Signs
      • Data Quality Challenges
      • Trial Cost Overruns
    • 9. Study Operations Early Warning Signs to Look for…
      • Sites express concerns or have many questions about the protocol or schedule of assessments
      • Poor alignment of monitoring visits with site enrollment
      • Inexperienced sites or monitors
      • High subject drop-out rate
      • Lag time for data entry at sites
      • High query rate (in general or around specific CRF fields)
      How to measure…
      • Use technology to track questions
      • Use technology to measure data collection and drop-out rates
      • Monitor query trends
      How to fix…
      • Maintain and FAQ starting from the PSV and IM through the study
      • Use experienced sites and monitors
      • Validate the protocol with the CRO and sites
      Related Warning Signs
      • Project team turnover
    • 10. Q&A Mark Shapiro, MBA, RAC [email_address]