Description
This module aims to introduce different trial designs appropriate for different phases and settings and to provide an introduction to statistical design and analysis which the students require both to understand and critique research evidence and also to help them with their research project.
The following topics will be covered:
- Phases of clinical trials
- Trial design as applicable to Phase 1/2/3 (3+3 vs model-based designs; single-arm vs randomised designs; parallel, factorial, cross-over; seamless designs, innovative clinical trial design for precision medicine: umbrella, basket, adaptive study designs)
- Sample size calculations with practical examples
- Choosing appropriate outcome measures
- Analysis - descriptive statistics, hypothesis testing, analysis of continuous, binary and time-to-event data
- Performance characteristics of clinical tests: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV)
Module deliveries for 2024/25 academic year
Last updated
This module description was last updated on 19th August 2024.
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