Clinical Trials

Learning Outcomes

Learning Outcomes

Having successfully completed this module you will be able to:

• Aware of the importance of specifying primary outcomes and planned analysis in the protocol
• Able to use the material covered in the course to contribute statistical expertise to the design of a new RCT
• Able to carry out standard power calculation for continuous normal and binary outcomes in two group parallel trials
• Able to analyze a AB/BA cross-over experiment with a continuous normally distributed outcome
• Aware of the rationale and objectives of meta-analyses
• Able to contribute the statistical elements to design a standard parallel group trials
• Able to critically review a paper reporting a randomized controlled trial.
• Familiar with terminology of the area
• Aware of the uses and limitations of the AB/BA cross-over design

• 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

Teaching and learning methods

18 lectures, self-study

Resources & Reading list

Textbooks

Greenhalgh T (1997). How to read a paper. BMJ Publishing Group.

Pocock S (1983). Clinical Trials: A Practical Approach. Statistical principles for clinical trials. Wiley.

Strike P W (1991). Statistical Methods in Laboratory Medicine. Butterworth.

Formative

This is how we’ll give you feedback as you are learning. It is not a formal test or exam.

Summative

This is how we’ll formally assess what you have learned in this module.

Referral

This is how we’ll assess you if you don’t meet the criteria to pass this module.

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.

Repeat Information

Repeat type: Internal & External