clinical trial research usyd

The University of Sydney - Sydney Medical School Handbook 2018

• Sydney Medical School Handbook
• University Home
• Medicine at Sydney
• Areas of study A-H
• Areas of study I-O
• Areas of study P-Z
• Course rules
• Course structure
• Unit of study table
• Unit of study descriptions

Clinical Trials Research

Graduate certificate in clinical trials research, graduate diploma in clinical trials research, master of clinical trials research.

*currently offered on a part-time basis only

The aim of the online Clinical Trials Research course is to provide a distinctive program targeted at medical doctors and allied health professionals, to help them acquire the expertise needed to design, develop, lead and conduct clinical trials. The course is led by the NHMRC Clinical Trials Centre (CTC), Australia's premier academic clinical trials research organisation. The NHMRC CTC course focuses on clinical trials design and research methodology and is offered via distance learning only. Graduates will gain a solid understanding of clinical trials methodologies underpinning the design of high quality studies, and the knowledge to lead, conduct and appropriately interpret the results of single and multi-centre clinical trials.

Course outcomes

Graduates will:

• understand the advantages and limitations of various trial designs
• gain a solid understanding of different scientific research methods that underpin the design of high quality clinical studies
• be able to lead and/or contribute to designing, efficiently conducting and appropriately interpreting the results of single and multi-centre clinical trials
• be able to identify and understand the appropriate literature with respect to clinical questions and clinical trials design
• have a solid understanding of the clinical trial process including the design, the statistical and ethical considerations, and the selection of participants.

Information about the programs

The graduate certificate requires students to undertake 24 credit points of study comprising four core units of study. The graduate diploma requires 36 credit points of study comprising six core units of study. The master's requires 48 credit points of study comprising six core units, a choice of electives (up to 6 credit points), and a capstone unit. The capstone unit will require each student to bring together concepts, principles and applications developed in the previous units of coursework study into a workable research protocol or project. The capstone will test the student's ability to integrate and consolidate their learning.

Flexible learning

The Clinical Trials Research courses are delivered 100 percent online, including lectures, tutorials, discussion forums and supplementary materials.

Further enquiries

© 2002-2024 The University of Sydney. Last Updated:  21-Nov-2017

ABN:  15 211 513 464. CRICOS Number:  00026A. Phone:  +61 2 9351 2222.

Authorised by:  Deputy Vice-Chancellor (Education).

Contact the University | Jobs | Library | Disclaimer | Privacy Statement | Accessibility

Current students

• Staff intranet
• Find an event

CLTR5007: Statistical Principles and Clinical Trials

2024 unit information.

Statistical principles and concepts required to design clinical trials and analyse trial results will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an introduction to hypothesis testing, confidence interval estimation and understanding of univariable and adjusted analyses. Students will undertake analyses of study data where outcomes are continuous, binary and time-to-event variables. Concepts and issues involved in performing landmark analyses and in identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of sample size calculations for clinical trials will be covered. Analyses will be performed using Excel and statistical software. SPSS software will be supported but students may use any package they are familiar with and have available. It is the student's responsibility to purchase the software. Details will be given at the beginning of the semester.

Unit details and rules

Managing faculty or university school:, medicine and health, enrolment rules, learning outcomes.

At the completion of this unit, you should be able to:

• LO1 . Understand the statistical principles behind the analysis and interpretation of trial data, including confidence intervals, hypothesis testing and p-values and appropriate presentation and interpretation of results.
• LO2 . Present and interpret summary data for continuous outcomes. Understand and test the assumptions required for analysis of continuous outcomes. Perform statistical comparisons of continuous outcomes between two groups. Perform and interpret adjusted analyses of continuous outcomes.
• LO3 . Present and interpret summary data for binary outcomes. Perform statistical comparisons of binary outcomes between two groups. Perform and interpret adjusted analyses of binary outcomes. Be aware of suitable analyses of binary outcomes when data are sparse.
• LO4 . Present and interpret summary data for time-to-event outcomes. Understand and test the assumptions required for analysis of time-to-event outcomes. Perform and interpret statistical comparisons of time-to-event outcomes between two groups. Perform and interpret adjusted analyses of time-to-event outcomes.
• LO5 . Understand the connection between statistical hypothesis testing and significance level, power and sample size. Perform sample size calculations for comparing continuous, binary and time-to-event outcomes in two groups. Understand and adjust for the impact of non-adherence to treatment and loss to follow-up in sample size calculations.
• LO6 . Critically appraise sample size calculations in a clinical trial protocol. Critically appraise and interpret statistical analyses of clinical trial data.

Unit availability

This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.

The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.

• Current year
• Previous years

Find your current year census dates

Modes of attendance (MoA)

This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about  modes of attendance  on our website.

Important enrolment information

Departmental permission requirements.

If you see the ‘Departmental Permission’ tag below a session, it means you need faculty or school approval to enrol. This may be because it’s an advanced unit, clinical placement, offshore unit, internship or there are limited places available.

You will be prompted to apply for departmental permission when you select this unit in Sydney Student.

Read our  information on departmental permission .

Select units

Useful links.

• Study dates
• Student Admin
• Health management
• Find an expert
• Media contacts

Student links

• How to log in to University systems
• Class timetables
• Our rankings
• Faculties and schools
• Campus locations
• Find a staff member
• Careers at Sydney
• Emergencies and personal safety

• Disclaimer and copyright
• Privacy statement
• Accessibility
• Website feedback