Module overview
This module provides an introduction to the statistical challenges arising in planning and conducting clinical trials. The main topics will cover: Clinical Trials of Parallel or cross-over design;
Randomization, Treatment Comparison and Confidence Intervals, the use of Baseline Characteristics, Multiplicity in trials, the Protocol, deciding the Sample size, Blinding, Reviewing a Paper reporting a clinical trial, Systematic Reviews and Meta-Analysis, Monitoring trials
Aims and Objectives
Learning Outcomes
Learning Outcomes
Having successfully completed this module you will be able to:
- Familiar with terminology of the area
- Able to critically review a paper reporting a randomized controlled trial.
- Able to use the material covered in the course to contribute statistical expertise to the design of a new RCT
- Aware of the rationale and objectives of meta-analyses
- Able to analyze a AB/BA cross-over experiment with a continuous normally distributed outcome
- Able to carry out standard power calculation for continuous normal and binary outcomes in two group parallel trials
- Able to contribute the statistical elements to design a standard parallel group trials
- Aware of the importance of specifying primary outcomes and planned analysis in the protocol
- Aware of the uses and limitations of the AB/BA cross-over design
Syllabus
• Clinical Trials of Parallel or cross-over design
• Randomization
• Treatment Comparison and Confidence Intervals
• the use of Baseline Characteristics
• Multiplicity in trials, the Protocol
• deciding the Sample size
• Blinding
• Reviewing a Paper reporting a clinical trial
• Systematic Reviews and Meta-Analysis
• Monitoring trials
Learning and Teaching
Teaching and learning methods
18 lectures, self-study
| Type | Hours |
|---|---|
| Independent Study | 57 |
| Teaching | 18 |
| Total study time | 75 |
Resources & Reading list
Textbooks
Pocock S (1983). Clinical Trials: A Practical Approach. Statistical principles for clinical trials. Wiley.
Strike P W (1991). Statistical Methods in Laboratory Medicine. Butterworth.
Greenhalgh T (1997). How to read a paper. BMJ Publishing Group.
Assessment
Formative
This is how we’ll give you feedback as you are learning. It is not a formal test or exam.
Group presentation
- Assessment Type: Formative
- Feedback:
- Final Assessment: No
- Group Work: No
- Percentage contribution: 100%
Summative
This is how we’ll formally assess what you have learned in this module.
| Method | Percentage contribution |
|---|---|
| Coursework | 100% |
Referral
This is how we’ll assess you if you don’t meet the criteria to pass this module.
| Method | Percentage contribution |
|---|---|
| Coursework assignment(s) | 100% |
Repeat
An internal repeat is where you take all of your modules again, including any you passed. An external repeat is where you only re-take the modules you failed.
| Method | Percentage contribution |
|---|---|
| Coursework assignment(s) | 100% |
Repeat Information
Repeat type: Internal & External