Regulatory Science Symposium: Clinical Trials Hurdles Session 1 and 2 - Challenges of Clinical Trial Management (2015)

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| anniexie@usc.edu