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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Top 5 Warning Signs Your Clinical Trial Is Off Track

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