Clinical Trials and IITs

Statistical collaboration from concept development through study reporting
The Biostatistics Core provides statistical support for cancer clinical trials, including investigator-initiated trials (IITs).

Involving a biostatistician during concept development allows the study design, endpoints, sample size, data collection, and analysis strategy to be developed together.

Our team provides statistical collaboration throughout the clinical trial lifecycle, with support tailored to the needs of each study at different stages of development and implementation.

Trial Development

• Development and evaluation of study design
• Endpoint selection
• Sample-size and power calculations
• Statistical sections of the protocol
• Statistical analysis plans
• Randomization
• Evaluation of data-collection forms
• Responses to scientific or statistical review comments

During the Trial

• Review of collected data for analytic readiness
• Monitoring and statistical reporting
• Interim analyses
• Protocol amendments
• Revisions to statistical plans
• Consultation regarding enrollment or data issues

Study Completion

• Final statistical analysis
• Tables and figures
• Interpretation of results
• Study reporting
• Abstracts and presentations
• Manuscript preparation
  

Support for IIT Concept Development

The Cancer Center provides subsidized Biostatistics support for development of eligible IIT concepts prior to submission to the Cancer Center IIT Committee.

Investigators should register the project before statistical work begins.

Funding and statistical support after concept development depend on the study, funding source, phase, size, and required activities and will be determined as part of trial planning.