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Unit of study_

BSTA5006: Design of Randomised Controlled Trials

Semester 2, 2022 [Online] - Camperdown/Darlington, Sydney

The aim of this unit is to enable students to understand and apply the principles of design and analysis of experiments, with a particular focus on randomised controlled trials (RCTs), to a level where they are able to contribute effectively as a statistician to the planning, conduct and reporting of a standard RCT. This unit covers: ethical considerations; principles and methods of randomisation in controlled trials; treatment allocation, blocking, stratification and allocation concealment; parallel, factorial and crossover designs including n-of-1 studies; practical issues in sample size determination; intention-to-treat principle; phase I dose-finding studies; phase II safety and efficacy studies; interim analyses and early stopping; multiple outcomes/endpoints, including surrogate outcomes, multiple tests and subgroup analyses, including adjustment of significance levels and P-values; missing data; reporting trial results and use of the CONSORT statement.

Unit details and rules

Unit code BSTA5006
Academic unit Public Health
Credit points 6
Prohibitions
? 
None
Prerequisites
? 
(PUBH5010 or BSTA5011 or CEPI5100) and (BSTA5100 or (BSTA5001 and BSTA5023))
Corequisites
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Erin Cvejic, erin.cvejic@sydney.edu.au
Type Description Weight Due Length
Assignment Assignment 1
Written assignment covering Modules 1 and 2
30% -
Due date: 29 Aug 2022 at 23:59
4-5 pages
Outcomes assessed: LO1 LO2
Assignment Assignment 2
Written assignment covering Modules 3 and 4
30% -
Due date: 26 Sep 2022 at 23:59
4-5 pages
Outcomes assessed: LO4 LO5 LO3
Assignment Assignment 3
Written assignment covering Modules 1 to 5
40% -
Due date: 31 Oct 2022 at 23:59
8-10 pages
Outcomes assessed: LO1 LO2 LO3 LO4 LO5

Assessment summary

  • Assignment 1 covers Modules 1 and 2
  • Assignment 2 covers Modules 3 and 4
  • Assignment 3 covers all Modules (1 to 5)

Detailed information for each assessment can be found on Canvas.

Assessment criteria

Grade

Mark Range

Description

AF

Absent fail

Range from 0 to 49

To be awarded to students who fail to demonstrate the learning outcomes for the unit at an acceptable standard through failure to submit or attend compulsory assessment tasks or to attend classes to the required level. 

FA

Fail

Range from 0 to less than 50

To be awarded to students who, in their performance in assessment tasks, fail to demonstrate the learning outcomes for the unit at an acceptable standard established by the faculty. 

PS

Pass

Range from 50 to less than 65

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an acceptable standard

CR

Credit

Range from 65 to less than 75

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a good standard

D

Distinction

Range from 75 to less than 85

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a very high standard

HD

High distinction

Range from 85 to 100 inclusive

To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an exceptional standard

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.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

Standard BCA policy for late penalties for submitted work is a 5% deduction from the earned mark for each day the assessment is late, up to a maximum of 50%.

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
Multiple weeks Module 1 - Randomisation Independent study (20 hr) LO1
Module 2 - Design of RCTs Independent study (20 hr) LO2 LO3
Module 3 - Sample Size Independent study (20 hr) LO5
Module 4 - Phase I and Phase II Studies Independent study (30 hr) LO4
Module 5 - Analysis and Reporting of RCTs / Multiple Comparisons Independent study (30 hr) LO2 LO4

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.

Required readings

Textbook: Matthews, J.N.S. Introduction to Randomized Controlled Clinical Trials, (Second Edition) Chapman & Hall/CRC Texts in Statistical Science. 

It will be necessary for you to have access to this book, as some of the course material is contained in the text book. An online copy can be accessed through the University of Sydney Library: https://sydney.primo.exlibrisgroup.com/permalink/61USYD_INST/2rsddf/cdi_askewsholts_vlebooks_9781420011302 

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. Identify the benefits of randomisation as a mechanism for reducing bias, and implement a variety of randomisation schemes
  • LO2. Demonstrate knowledge of the principles behind the common experimental designs
  • LO3. Describe the efficiency advantages of crossover designs, and be able to design and interpret the two-period crossover study
  • LO4. Demonstrate an understanding of the principles underlying Phase I, II, III and IV studies, as well as an appreciation of the scientific basis underlying issues in clinical studies including intention-to-treat, blinding, interim analyses, subgroup analyses and the handling of missing data
  • LO5. Appreciate the importance of sample size in clinical studies, and perform sample size calculations for a variety of trial designs with different outcomes

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.

This unit was last delivered in Semester 2 2021. Following recent student feedback, detailed feedback on the evaluated assignments will be provided within two weeks of their submission, and further updates on the course material to reflect the text book by Matthews will be implemented. Stata software references for Module 3 have been updated since the last delivery in 2021. At the request of students, more videos and additional online sessions at a range of times will be added to the unit in 2022.

This unit is delivered externally as part of the Biostatistics Collaboration of Australia (BCA).

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.