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Unit of study_

CLTR5004: Advanced Trial Design

Semester 2, 2023 [Online] - Camperdown/Darlington, Sydney

Candidates will be taught skills to design and interpret equivalence and non-inferiority trials, cluster randomised trials and crossover trials. Biomarker-based designs are also covered including enrichment, hybrid and novel designs such as basket, umbrella, and platform trials. The pros and cons of each design are outlined. The unit will equip students with the ability to determine the most appropriate and optimal design to answer a clinical research question. Special aspects relating to cross-over studies will be taught. The difference between prognostic and predictive factors will be illustrated. Techniques to validly incorporate composite end points and co-primary endpoints will be learnt. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.

Unit details and rules

Unit code CLTR5004
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 Rachel O'Connell, rachel.oconnell@sydney.edu.au
Type Description Weight Due Length
Assignment hurdle task Assignment 2
Long Assignment
40% Formal exam period
Due date: 13 Nov 2023 at 23:59
9 pages max
Outcomes assessed: LO1 LO2 LO3 LO4 LO5 LO6 LO7
Online task hurdle task Quiz 1
Short Assignment
10% Week 05
Due date: 28 Aug 2023 at 23:59
2 pages max
Outcomes assessed: LO1 LO2
Assignment hurdle task Assignment 1
Long Assignment
40% Week 09
Due date: 02 Oct 2023 at 23:59
7 pages max
Outcomes assessed: LO1 LO4 LO3 LO2
Online task hurdle task Quiz 2
Short Assignment
10% Week 11
Due date: 16 Oct 2023 at 23:59
2 pages max
Outcomes assessed: LO1 LO5 LO4 LO3 LO2
hurdle task = hurdle task ?

Assessment summary

Both assignments must be passed in order to pass the course. Detailed information for each assessment can be found on Canvas.

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
Week 01 Module 1: trial designs - non‐inferiority and equivalence Online class (10 hr) LO1 LO2
Week 02 Module 1: trial designs - non‐inferiority and equivalence Online class (10 hr) LO1 LO2
Week 03 Module 2: trial designs - dealing with clusters Online class (10 hr) LO1
Week 04 Module 2: trial designs - dealing with clusters Online class (10 hr) LO1
Week 05 Module 3: trial designs - crossover studies Online class (10 hr) LO1
Week 06 Module 4: trial designs - complex and specialised designs Online class (10 hr) LO1 LO3 LO4
Week 07 Module 5: advanced endpoint decisions Online class (10 hr) LO2 LO5
Week 08 Module 5: advanced endpoint decisions Online class (10 hr) LO2 LO5
Week 09 Module 6: monitoring trial data Online class (10 hr) LO6
Week 10 Module 6: monitoring trial data Online class (10 hr) LO6
Week 11 Module 7: sub‐study design and implementation Online class (10 hr) LO7
Week 12 Module 7: sub‐study design and implementation Online class (10 hr) LO7
Week 13 Revision Online class (10 hr)  

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. Determine the appropriate study design that will provide the best evidence to answer a clinical research question.
  • LO2. Understand the impact of non-compliance on design, analysis and interpretation of results.
  • LO3. Understand the difference between prognostic and predictive factors.
  • LO4. Have knowledge of biomarker-based designs including basket, platform, and umbrella. Additionally be aware of strategies such as adaptive randomisation to facilitate allocation into such designs.
  • LO5. Understand the different types of trial endpoints (composite, co-primary and surrogate) and the key issues associated with each.
  • LO6. Understand the role of the Independent Safety and Data Monitoring Committee and the statistical and ethical issues when monitoring accumulating data from clinical trials.
  • LO7. Understand the key principles involved in substudy design and implementation.

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.

No changes have been made since this unit was last offered

Unit materials: Please work through the notes and papers at your own pace, discussing difficult concepts or questions as needed on Canvas. Reading journal articles and extracting the relevant information is an important skill, and not easy to develop. Please note the course schedule for each module and the assessment deadlines.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.