Study Design in Clinical Research

This subject has the following teaching availabilities in 2016:

170 hours per 12.5 credit point subject.

To enrol in this subject, you must be admitted in either N28AA, N12AA, N34AA or N01AA. This subject is not available for students admitted in any other courses.

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For the purposes of considering requests for Reasonable Adjustments under the Disability Standards for Education (Commonwealth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this course are articulated in the Course Overview, Objectives and Generic Skills sections of this entry.

It is University policy to take all reasonable steps to minimise the impact of disability upon academic study, and reasonable adjustments will be made to enhance a student's participation in the University's programs. Students who feel their disability may impact on meeting the requirements of this course are encouraged to discuss this matter with the Student Equity and Disability Support Team: http://www.services.unimelb.edu.au/disability/

The subject will introduce students to the principles of Study Design in Clinical Research. Key areas that will be covered are:

1. Study Design principles
2. Design options including designs and issues specific to Clinical Research such as:
   - Oncology and survival studies
   - Phase I, Phase II and Phase III trials
   - Pharmaceutical trials
   - Surgical and device trials
   - Equivalence studies
   - Open label trials
   - Diagnostic trials
   - Screening trials
   - Preventive trials
   - Genetic/Biomarker trials
3. Effects of recruitment, retention and attrition on study design, planning & effectiveness
4. Matching study objectives with optimal study designs
5. Data management and data interpretation
6. Critical analysis and review of published studies and study designs

The subject will introduce students to the principles of study design in clinical research, exploring the benefits and disadvantages of selected study designs.

Based on this information, students will explore the correlation between research objectives, study design, data analysis and clinical practice to appreciate the inter-relatedness of each of these elements in good clinical study design. This will include critical evaluation of published clinical research studies.

The subject will have two assessments:
1. A 2000-3000 word critical evaluation of a selection of published clinical research studies (50%) due 3 weeks after the completion of the subject
2. A 2000-3000 word assignment designing a clinical research study for a specified scenario (50%) due 8 weeks after the completion of the subject.

Foundations of Clinical Research (supplied to students).

Students will be provided with articles and references that support the teaching program as part of their course materials.

This subject is not available as a breadth subject.

Students who successfully complete this course will gain:

• An understanding of the context of research and how it advances knowledge
• An understanding of the complexities of research activities
• An appreciation of the limitations of research findings
• Clearer understanding of the principles of research design
• Attention to detail