Clinical Trials Hurdles Session 1 and 2: Challenges of Clinical Trial Management (2015)

In this series, we will discuss how to successfully support and manage clinical trials.

Course Syllabus/Topics

April W. Armstrong, MD MPH:

  • Phases of clinical investigative research study:
    • Protocol development
    • Review to activation
    • Study conduct
    • Reporting dissemination
  • Challenges in conducting investigator-initiated research:
    • Identify available clinical research support resources
    • Maintain a qualified and on-demand study coordinator
    • Access expertise in recruiting, budgeting and biostatistics
  • Clinical Research Support (CRS): The single stop access to all available services for the investigator to develop, activate, conduct and report results for clinical trials. The focus is mainly on the investigator-initiated studies and non-cancer trials.
  • CRS group services available for the efficiency of the investigation: 
    • Protocol development and study planning:
      • Research navigation
      • Clinical research informatics
      • Biostatistics and study design
      • Recruitment support
      • Budgeting
      • Technology transfer
    • Review to activation
      • Feasibility review
      • Scientific review
      • IRB review, study registration
    • Study conduct
      • Recruitment
      • Study coordinator pool, Clinical Trial Unit (CTU), clinical trial and data management systems
      • Coordination of ancillary services like radiology, laboratory and pharmacy
      • Study monitoring and closure

Deena Bernstein, MHS:

  • Hurdles in clinical trials
    • Feasibility
    • Protocol complexity
    • Patient recruitment
    • Staff turnover
    • Site sustainability
  • Feasibility elements
    • Protocol review
    • All site stakeholders
    • Enrollment acceptance
    • Protocol procedure
    • Available vendors
    • Patient population
    • Protocol review
  • Feasibility tools
    • Protocol
    • Logistics
    • Routine care vs. study related
    • Identify challenges
    • Outsourced sub-contractors
    • Accountability

A manager should create a process for your site, engage the study team, learn from the process, often revise feasibility assessment, include historical enrolment metrics, review reliable patient populations and, not be afraid to decline a study.

  • Protocol complexity
    • Regulatory pressure
    • Sub studies tied to main protocol
    • Patient safety
    • Extended out of screening periods
    • Optional biomarkers and labs/tissue sampling

In order to control complexity, mangers should have patient focus groups, site focus groups, PI input to protocol design, and protocol simulation (mock trials).

  • Site enrollment ratios
    • Exceed target: 13%
    • Meet target: 39>#/span###
    • Under target: 37%;
    • Fail to enroll a single patient: 11>#/span###
  • Patient recruitment factors
    • Not meeting criteria
    • Awareness
    • Public perception
    • Advertising yield
    • Protocol requirement
  • Staff turnover
    • Employment tactics
    • On-boarding
    • Training
    • CRC work load
    • Competitive geographic area
    • Engaging staff
    • Career path
    • Incentives

To solve staff turnover problems, team building activities can be used to encourage staff engagement

  • Site sustainability
    • Cash flow – 90 days
    • Monthly payment terms
    • Opportunities in US increasing
    • Consider uncompensated activities
      • RBM/monitoring
      • Lab processing
      • Work effort


Accompanying text created by Annie Xie | Undergraduate Research Associate | Provost's Undergraduate Research Fellow and SC-CTSI Student Worker|

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.