Statistical Considerations When Developing Your Research Design
This workshop covers statistical issues, especially techniques that reduce bias and enhance precision, relevant to the design of clinical trials. Examples focus on Phase 2-3 clinical trials. It is co-sponsored by the Office of Research and is presented by Cathie Spino, ScD, Research Professor in Biostatistics.
This two-hour workshop will begin with a lecture on the fundamentals, following by ample time for questions on issues relevant to the audience’s experience in trial design.
Following this workshop, you will be able to:
- Design a Phase 2-3 clinical trial that translates study objectives and hypotheses into a study strategy that optimizes the ability to reach a scientific conclusion that is valid and precise
- Discuss the strengths and weaknesses of parallel-group and crossover designs, blinding, and randomization
- Apply techniques to minimize bias in the study design
- Review existing resources at the University of Michigan for statistical and clinical study design consulting.
Target Audience: Physicians and other faculty who develop or contribute to clinical trials