CROs and Sponsors alike say they see trial project teams making the same mistakes over and over. Missteps like: teams not following standard project management processes, not staffing the clinical trial appropriately, not assessing the risks (and managing them) that could imperil their projects, and the the list goes on.

A few weeks back Clinipace hosted an educational webcast to assist project managers identify, measure, and fix the top challenges faced by clinical trial teams. Any of these impacting your trial?

#1: First Subject, First Visit Delayed
What 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

#2: Enrollment Rate Does Not Meet Expectations
What 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

#3: Trial Cost Overruns
What 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

#4: Project Team Turnover
What 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

#5: Data Quality Challenges
What 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