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Unit of study_

CLTR5002: Interpretation of Trial Analyses

Semester 1, 2022 [Online] - Camperdown/Darlington, Sydney

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

Unit code CLTR5002
Academic unit NHMRC Clinical Trials Centre
Credit points 6
Prohibitions
? 
None
Prerequisites
? 
CLTR5001 and CLTR5007
Corequisites
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Kristy Robledo, kristy.robledo@sydney.edu.au
Tutor(s) Kristy Robledo, kristy.robledo@sydney.edu.au
Andrew Martin, a.martin@sydney.edu.au
Type Description Weight Due Length
Assignment Methodological appraisal 2
Submitted online assessment via canvas
40% Formal exam period 2000 words
Assignment Article appraisal
Submitted online assessment via canvas
10% Week 04 Prepare 1-3 sentences for each aspect
Outcomes assessed: LO2 LO7 LO3
Assignment Peer assessment
Submitted online assessment via canvas
5% Week 05 100 words
Outcomes assessed: LO2 LO7 LO4 LO3
Assignment Online quiz
Submitted online quiz via canvas
20% Week 08 90 minutes
Assignment Methodological appraisal 1
Submitted online assessment via canvas
25% Week 11 1000 words

Assessment summary

  • Article appraisal: Appraise a case studies across a set of 8 individual aspects.
  • Peer assessment: Assessment of Task 1 submission by peer.
  • Online quiz: Short answer, multiple-choice, true/false quiz.
  • Methodological appraisal 1: Prepare methodological appraisal of case studies.
  • Methodological appraisal 2: Prepare methodological appraisal of case studies.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name

Mark range

Description

High distinction

85 - 100

 

Distinction

75 - 84

 

Credit

65 - 74

 

Pass

50 - 64

 

Fail

0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

Academic integrity

The Current Student website  provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.  

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

WK Topic Learning activity Learning outcomes
Weekly See canvas Online class (130 hr) LO1 LO2 LO3 LO4 LO5 LO6 LO7 LO8 LO9 LO10 LO11 LO12 LO13 LO14 LO15 LO16 LO17 LO18 LO19 LO20 LO21 LO22 LO23 LO24 LO25 LO26 LO27

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

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.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

This section outlines changes made to this unit following staff and student reviews.

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Disclaimer

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