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Advanced Clinical Trial Design (CLRS90028)

Graduate courseworkPoints: 25On Campus (Parkville)

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Year of offer2019
Subject levelGraduate coursework
Subject codeCLRS90028
FeesSubject EFTSL, Level, Discipline & Census Date

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: 19 July 2019