Study Design in Clinical Research
Description
The subject will introduce students to the principles of Study Design in Clinical Research. Key areas that will be covered are:
- Study Design principles
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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
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Effects of recruitment, retention and attrition on study design, planning & effectiveness
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Matching study objectives with optimal study designs
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Data management and data interpretation
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Critical analysis and review of published studies and study designs
Subject Code
CLRS90011
Credit Points
12.5 points
Objectives
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.
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
Pre-requisites and/or Co-requisites
For both the Professional Certificate and Graduate Certificate in Clinical Research the entry requirements are:
- An undergraduate degree or equivalent qualification in medicine, an allied health profession, nursing, science or social science which is recognised by the University as evidence of adequate preparation for the course PLUS
- Documented evidence of at least one year's full-time relevant professional work experience in a
medical, scientific or allied health environment.
All students will be required to meet the English Language requirements of the University.
Mode of Delivery
Intensive 4 day blocks
Student Commitment
Students should expect to undertake a minimum of 120 hours lectures, research, reading, writing etc to complete this subject successfully
Assessment
The subject will have 2 assessments:
1. A 2000-3000 word critical evaluation of a selection of published clinical research studies (50%) due 4 weeks after the completion of the subject
2. A 2000-3000 word assignment designing a clinical research study for a specified scenario (50%) due 6 weeks after the completion of the subject
Subject Coordinator
Prof Steve Farish
Venue
Venue: Hawthorn Campus
Dates
Dates: 22, 23, 25 & 26 October 2012
Course Fee
Program Fees for 2012 are $2,350 per 12.5 point subject, making total costs as follows:
- The Professional Certificate - $4,700
- The Graduate Certificate - $9,400
The course fee includes:
- All course materials and assessment
- Access to on-line databases required
- Morning, afternoon tea and lunch on each day of teaching
For further information contact
Mary Georges 9810 3185 or m.georges@commerical.unimelb.edu.au
Application Process
Applications are managed by Student Services.