Clinical Research in Oncology

This subject has the following teaching availabilities in 2012:

In addition to face-to-face teaching time of 48 hours, students should expect to undertake a minimum of 160 hours research, reading, writing and general study to complete this subject successfully.

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For the purposes of considering requests for Reasonable Adjustments under the Disability Standards for Education (Cwth 2005), and Students Experiencing Academic Disadvantage Policy, academic requirements for this subject are articulated in the Subject Description, Subject Objectives, Generic Skills and Assessment Requirements of this entry.
The University is dedicated to provide support to those with special requirements. Further details on the disability support scheme can be found at the Disability Liaison Unit website: http://www.services.unimelb.edu.au/disability/

Topics covered include:
 A global overview of the burden of cancer / a public health perspective on cancer control
 Career opportunities incorporating clinical research
 Australian perspectives in cancer clinical research
 Types of research in clinical oncology, including phase I, II and III drug trials, studies evaluating biological agents (incl vaccines), chemotherapy, radiation, combined chemoradiation, surgical and supportive care studies
 Endpoints in oncology clinical trials – including overall survival, progression-free survival, response rate, quality of life benefit, clinical benefit, utility analysis (and economic evaluations), proof of efficacy (lab / surrogate endpoints)
 Imaging modalities in oncology, including functional imaging
 The process of new drug development, approval and marketing – how this may differ from other settings
 Issues in clinical trial design for phase I, phase II and phase III studies – how this may differ from other settings
 Cancer prevention studies
 Cancer detection – screening and early detection
 The concept outline / protocol development
 Practical aspects involved in the conduct of clinical trials, including the development of case report forms, ethics submission, regulatory issues, start-up and ongoing maintenance of the study
 Ethics and informed consent – aspects requiring special attention in oncology and palliative care studies
 From data to publication / the CONSORT statement (consolidated standards of reporting trials) on reporting of research data

Students who successfully complete this subject will be able to:
Understand the breadth of opportunity for clinical research in oncology
Be familiar with all types of research design conducted within oncology clinical research
Understand the various outcomes assessed by oncology clinical trials, including how and why these might differ from other disciplines
Be familiar with surrogate endpoints, derived from laboratory and functional imaging studies
Be familiar with ethical and legal considerations relevant to clinical research in oncology
Understand all aspects of the concept outline / protocol development
Understand the process and requirements for successful conduct of clinical research in oncology
Critically appraise research presentations and publications in oncology research

Three 2,000 word assignments worth 20% each. One two hour examination worth 40%.

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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.

Please refer to the website.