69508 Clinical Trials: Evidence and Design
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Subject handbook information prior to 2025 is available in the Archives.
Credit points: 2 cp
Result type: Grade and marks
There are course requisites for this subject. See access conditions.
Anti-requisite(s): 60002 Clinical Trials: Evidence and Design
Description
Clinical trials are an essential tool for establishing the safety and efficacy of medical treatments and are integral to evidence-based medicine and the regulation of therapeutic goods. Understanding how to interpret clinical evidence is important for a range of professions including pharmaceutical, clinical practice, and health research and policy.
In this subject, students learn about different elements of clinical trial design and how this relates to the quality of evidence that is produced. Students learn how to interpret the evidence from clinical trials, and how this evidence is used for drug development, clinical care and the approval of therapeutic goods.
Subject learning objectives (SLOs)
Upon successful completion of this subject students should be able to:
| 1. | Explain the context of clinical trials and why they are used |
|---|---|
| 2. | Identify different elements of trial design and their associated advantages and limitations |
| 3. | Evaluate evidence from clinical trials with reference to the study design, reported statistics and study objectives |
| 4. | Describe how evidence from clinical trials can be translated into treatments, policy and clinical guidelines |
Course intended learning outcomes (CILOs)
This subject also contributes specifically to the development of following course intended learning outcomes:
- Critically appraise and apply advanced knowledge and technical skills to discipline specific projects to inform professional practice in science and medical biotechnology. (1.1)
- Assess, argue for, and conduct independent research and solving complex problems by applying a research methodology to address a research need in a relevant professional context. (2.1)
- Develop, prepare, and engage, at times collaboratively, in safe, ethical, organised and transparent work practices that mitigate risk and contribute to solving global health problems in the context of science and medical biotechnology. (3.1)
- Present and communicate complex ideas and justifications using appropriate communication approaches from a variety of methods (oral, written, visual) to communicate with discipline experts, scientists, industry, and the general public. (5.1)
Contribution to the development of graduate attributes
You will develop your disciplinary knowledge of clinical trials, their design, interpretation and applications through research and real-world examples throughout the online modules.
- Graduate Attribute 1.0: Disciplinary Knowledge
- Through the online modules and workshops, you will learn about the history, design, and application of evidence from clinical trials.
- Graduate Attribute 2.0: Research, inquiry and critical thinking
- Through the interactive activities in the online modules, and discussions in workshops you will develop the ability to analyse the information from cilnical trials, and to synthesise information from multiple sources to judge the efficacy of an intervention tested in clinical trials.
- Graduate Attribute 3.0: Professional, ethical, and social responsibility
- Through the online modules and interactive online discussions, you will learn about the ethical frameworks essential to the design and conduct of clinical trials.
- Graduate Attribute 5.0: Communication
- You will develop your formal written communication skills in the final assessment task. You will write a report from the perspective of a clinical trials expert reviewing an intervention tested in clinical trials, based on materials discussed in the modules and online workshops.
Teaching and learning strategies
This subject will be delivered entirely online through the learning platform Canvas, and live streamed online workshops via Zoom. You will work through content areas or ‘modules’ which are designed to build your knowledge in the foundational aspects of clinical trials and their interpretation. The workshops will provide an opportunity to hear from experts in the field and ask questions, as well as practise the necessary skills for completion of the final assessment.
At the beginning of the subject, you will be introduced to the topic and start to interact with a range of materials in different formats. All materials are designed to provide you with an active learning experience and you will be expected to think critically about the information you receive. You will have the opportunity to connect with your peers during the subject by engaging in interactive content and using the discussion board and interactive activities within Canvas, as well as the live streamed online workshops.
Feedback will be given throughout the subject. Instructors will provide feedback on the online interactive activities, as well as in the live online workshops. You will receive immediate feedback on completion of each online quiz, and written feedback on the final assessment.
Content (topics)
Module 1: Introduction to clinical trials
- Brief history of the development of clinical trials
- Pre-clinical and clinical research
- Phases of clinical trials
- Ethical and regulatory frameworks.
Module 2: Elements of clinical trial design
- Hierarchy of evidence
- Bias and confounding
- Power and sample size
- Common clinical trial designs
Module 3: Interpretation of clinical trials
- CONSORT guidelines
- Intention to treat analysis
- Statistical inference, p-values and effect sizes
- Clinical significance
Module 4: Application of evidence from clinical trials
- Approval of therapeutic goods
- Meta-analyses and clinical guidelines
- Public health policy
Assessment
Assessment task 1: Weekly Multiple Choice Quizzes
| Intent: | The following graduate attributes are assessed in this task:
|
|---|---|
| Objective(s): | This assessment task addresses subject learning objective(s): 1, 2, 3 and 4 This assessment task contributes to the development of course intended learning outcome(s): 1.1, 2.1 and 3.1 |
| Type: | Quiz/test |
| Groupwork: | Individual |
| Weight: | 40% |
| Length: | 10 multiple choice questions per module. |
| Criteria: | Correct responses to multiple choice questions |
Assessment task 2: Written Report
| Intent: | The following graduate attributes are assessed in this task: 1. Disciplinary Knowledge 2. Research inquiry and critical thinking 5. Communication |
|---|---|
| Objective(s): | This assessment task addresses subject learning objective(s): 1, 2, 3 and 4 This assessment task contributes to the development of course intended learning outcome(s): 1.1, 2.1 and 5.1 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 60% |
| Length: | Aproximately 1500 words |
| Criteria: | You will be assessed on your ability to:
|
Minimum requirements
Students must obtain a minimum of 50% for the cumulative marks in the subject in order to pass.