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Unit of study_
CLTR5002: Interpretation of Trial Analyses
2024 unit information
This unit addresses a number of key issues that arise in the analysis of clinical trial data. It will equip students with the ability to critically evaluate and interpret trial analyses, as well as provide them with an understanding of the principles underpinning good analysis practices. Modules will provide an introduction to the interpretation of treatment effect estimates, adjusted/stratified analyses, subgroup analysis, interim analyses, dealing with multiplicity, dealing with missing data, analysis of phase II designs, and how to reach appropriate decisions about the continued evaluation of an intervention, or its recommended implementation in practice.
Unit details and rules
Managing faculty or University school:
Medicine and Health
| Study level | Postgraduate |
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| Academic unit | NHMRC Clinical Trials Centre |
| Credit points | 6 |
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Prerequisites:
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CLTR5001 and CLTR5007 |
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
- LO1. describe the key methodological principles underpinning a rigorous analysis of clinical trial data and the ethical implications of the approaches employed
- LO2. provide a clearly written informed appraisal of the results of analyses performed on effectiveness and safety parameters with regard to the specified objective(s) of the study
- LO3. provide a clearly written assessment of a peer’s appraisal
- LO4. understand issues to consider when reaching recommendations as to whether a program of trials research undertaken to evaluate and develop a health intervention should be continued, modified or halted on the basis of evidence from an early phase trial
- LO5. demonstrate a cross-disciplinary perspective that the role of confirmatory Phase III trials to generate evidence that is sufficiently robust to base decisions about the adoption of an intervention in clinical practice
- LO6. understand summary statistics commonly used to describe clinical data and quantify estimated treatment effects, as well as explain the role of p-values and confidence intervals
- LO7. describe the key methodological principles underpinning the pre-specification of analysis approaches and the intention-to-treat analysis principle
- LO8. understand in general terms how to interpret the results of equivalence and non-inferiority trials
- LO9. understand what a stratified/adjusted analysis involves and the function it serves
- LO10. describe how to undertake a stratified/adjusted analyses of continuous, binary, and time-to-event outcomes
- LO11. interpret the results of stratified/adjusted analyses
- LO12. describe the problem that arises as a consequence of multiple hypothesis testing and its implication
- LO13. identify circumstances in which the multiplicity problem arises in clinical trials
- LO14. understand approaches for constraining the consequences of multiple hypothesis testing
- LO15. describe the strength and limitations of subgroup analyses
- LO16. understand the concept of effect modification and how to appropriately undertake subgroup analysis
- LO17. correctly interpret the results of subgroup analysis
- LO18. identify contexts in which monitoring/interim analyses could be applicable in a clinical trial
- LO19. understand the principles underpinning statistical approaches for constraining the risk of a false-positive result when interim analyses are undertaken
- LO20. describe the function of an independent data safety monitoring board
- LO21. demonstrate competency in interpreting results from interim analyses and aware of the relevant statistical and ethical issues associated with interim analyses and early stopping
- LO22. understand why missing outcome data is of methodological concern in the context of clinical trials
- LO23. describe common ways in which missing data arise and strategies for minimising the incidence of missing data
- LO24. distinguish the principal analysis approaches for accommodating missing data in clinical trials
- LO25. describe the strengths and limitations of common Phase II trial designs
- LO26. provide a sound interpretation of the results of Phase II trials
- LO27. recommend whether or not further evaluation is warranted on the basis of the results of preliminary studies.
Unit availability
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Modes of attendance (MoA)
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