Investigator Initiated Trial (IIT) Support

IIT Support

We provide biostatistical leadership and analytic collaborative support to members of the Cancer Center for IITs. In general, IITs can be Phase I, Phase II or Phase III Trials and may be multi-site studies. Including a Biostatistician early on in your trial design will ensure a more efficient IIT development and approval process. When feasible, we advocate for the use of model based approaches like the CRM and its variations as well as model assisted designs such as the BOIN and keyboard approach in Phase I studies.

Have an idea for an IIT? Contact us and enjoy up to 10 hours of free consulting support to develop your idea through determining the primary endpoint, trial design options, safety monitoring, sample size calculations, and much more. We will assist you in writing a proposal to help secure funding to bring your idea to fruition.


  • Protocol development;
    • Trial design selection
    • Identifying outcomes
    • Creating testable hypotheses
    • Sample size estimation
    • Randomization schemes
    • Creating /Developing a statistical analysis plan
    • Safety and toxicity evaluations
  • eCRFs
  • Validate collected data to ensure completeness to support the final statistical analysis
  • Interim analysis
    • Safety monitoring and stopping criteria
  • Data analysis and report
  • Authoring of manuscripts to present the results of the study


Study/Trial Examples (not an exhaustive list):

  • Pilot or feasibility study
  • Phase I trial (with Expansion)
    • Algorithm based designs: 3+3, accelerated titration design, and
    • Model based designs: CRM, BCRM, BOIN, MTPI, Keyboard Design and
  • Phase II trial
    • Simon’s two stage design
  • Phase III trial
    • Group Sequential design
    • Adaptive design
  • Pragmatic trial


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