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Advanced Clinical Trial Design (CLRS90028)

Graduate courseworkPoints: 25On Campus (Parkville)

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Overview

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April
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Clinical trials are designed to test new methods of screening, prevention, diagnosis and treatment of disease and are essential to discovering whether new healthcare interventions improve outcomes for patients. This subject will provide students a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials, in particular the randomized controlled trial (RCT), and will build on the concepts introduced at the graduate certificate level. Fundamental concepts associated with the design, implementation and analysis of RCTs will be explored including selecting, recruiting and consenting study subjects, determination of study duration, comparing multiple groups and/or endpoints, designing randomisation protocols, study monitoring, quality assurance and early termination.

Delivery will be across three intensive teaching periods:

Intensive Teaching Period 1 (3 days)

Trial Design
Randomization, Blinding and Allocation
Outcome Selection

Intensive Teaching Period 2 (3 days)

Good Clinical Practice
Quality Assurance & Regulatory Processes
Study Management
Informed Consent

Intensive Teaching Period 3 (3 days)

Stakeholder Involvement
Compliance and Follow-Up
Data Storage, Management and Analysis
Clinical Trials in Rural/Remote & Vulnerable Populations

This subject provides individuals from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a biomedical science-based background with a conceptual framework in design, development and conduct of RCTs. This subject serves as a basis for advanced study in the Master of Clinical Research.

Intended learning outcomes

At the completion of this subject students should be able to;

  • compare and contrast clinical trial designs and choose an appropriate design in a range of disease-settings and/or clinical populations;
  • explain the phases of clinical trials and the selection of appropriate clinical populations and/or outcome measures within each phase;
  • describe the characteristics of a randomized controlled trial (RCT) and compare and contrast this to other types of clinical trial designs;
  • define and explain the principles of randomisation, allocation and blinding in the context of RCTs and propose methods to carry out randomization, allocation and blinding to prevent bias;
  • describe the ethical and regulatory process required for the conduct of a clinical trial by analysing appropriate and inappropriate research conduct;
  • demonstrate an in-depth understanding of the proper management of a clinical trial and the steps needed to ensure maintenance of the highest levels of good clinical research practice;
  • demonstrate an in-depth understanding of the principles of informed consent by comparing and contrasting issues such as waiver of consent, opt in/out consent and e-Consent;
  • discuss the study design and ethical issues associated with conducting clinical trials in vulnerable and rural/remote populations;
  • recognise the value of stakeholder involvement in clinical trial design/conduct by analysing scenarios where stakeholder involvement has helped/hindered clinical trial design/conduct;
  • describe the pathway by which patients and their data move through clinical trial from screening, treatment, follow-up and after trial care;
  • critique methods to ensure maximum compliance with treatment and follow-up within a trial protocol;
  • the ability to comprehend complex scientific information and communicate advanced concepts in written and oral form;
  • demonstrate sufficient preparatory knowledge for more detailed study in clinical research at the Masters level

Last updated: 31 January 2024

Eligibility and requirements

Prerequisites

None

Corequisites

None

Non-allowed subjects

None

Inherent requirements (core participation requirements)

The University of Melbourne is committed to providing students with reasonable adjustments to assessment and participation under the Disability Standards for Education (2005), and the Assessment and Results Policy (MPF1326). Students are expected to meet the core participation requirements for their course. These can be viewed under Entry and Participation Requirements for the course outlines in the Handbook.

Further details on how to seek academic adjustments can be found on the Student Equity and Disability Support website: http://services.unimelb.edu.au/student-equity/home

Last updated: 31 January 2024

Assessment

DescriptionTimingPercentage

Reflective Essay - discussing an issue/topic/concept explored during Intensive Teaching Period 1

  • 1000 words
During the teaching period10%

Reflective essay - discussing an issue/topic/concept explored during Intensive Teaching Period 2

  • 1000 words
During the teaching period10%

Reflective essay - discussing an issue/topic/concept explored during Intensive Teaching Period 3

  • 1000 words
During the teaching period10%

Critical appraisal of two published RCTs in a clinically relevant area (due 2 weeks after completion of Intensive Teaching Period 3)

  • 3000 words
End of semester30%

Design a protocol, including relevant PLS and consent forms, for an RCT using a standard ethics application template (due 4 weeks after completion of Intensive Teaching Period 3).

  • 4000 words
End of semester40%

Last updated: 31 January 2024

Dates & times

What do these dates mean

Visit this webpage to find out about these key dates, including how they impact on:

  • Your tuition fees, academic transcript and statements.
  • And for Commonwealth Supported students, your:
    - Student Learning Entitlement. This applies to all students enrolled in a Commonwealth Supported Place (CSP).

    Subjects withdrawn after the census date (including up to the ‘last day to withdraw without fail’) count toward the Student Learning Entitlement.

Last updated: 31 January 2024

Further information

  • Texts

    Prescribed texts

    There are no specifically prescribed or recommended texts for this subject.

  • Available through the Community Access Program

    About the Community Access Program (CAP)

    This subject is available through the Community Access Program (also called Single Subject Studies) which allows you to enrol in single subjects offered by the University of Melbourne, without the commitment required to complete a whole degree.

    Entry requirements including prerequisites may apply. Please refer to the CAP applications page for further information.

Last updated: 31 January 2024