BIO1204 Tutorial - Clinical Trials PDF
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University of Southern Queensland
Sarah Myer
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Summary
This document is a tutorial on clinical trials for a biomedical science course at the University of Southern Queensland. It covers the stages of clinical trials, from preclinical studies to phase IV trials, and includes an activity on ordering the steps in drug development.
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BIO1204 Introduction to Biomedical Science Tutorial Clinical Trials The material in this lecture and course should be not uploaded or shared on any online platform outside of the University of Southern Queensland....
BIO1204 Introduction to Biomedical Science Tutorial Clinical Trials The material in this lecture and course should be not uploaded or shared on any online platform outside of the University of Southern Queensland. COMMONWEALTH OF AUSTRALIA Copyright Regulations 1969 WARNING This material has been copied and communicated to you by or on behalf of The University of Southern Queensland pursuant to Part VA of the Copyright Act 1968 (the Act). The material in this communication may be subject to copyright under the Act. Any further copying or communication of this material by you may be the subject of copyright protection under the Act. Do not remove this notice. 2 Acknowledgement of Country In the spirit of reconciliation, the University of Southern Queensland acknowledges the traditional custodians of the lands and waterways where the University is located. Further, we acknowledge the cultural diversity of Aboriginal and Torres Strait Islander peoples and pay respect to Elders past, present and future. 3 ‘Bench to Bedside’ Moving ‘basic’ laboratory-based research to an application in medicine http://ncdnaday.org/wp-content/uploads/2017/02/benchtobedside.png 4 Biomedical science research - drug development Phase IV – follow up within the general population TGA: Therapeutic Goods Association www.cure4mnd.org 5 Clinical Trials 6 Clinical Trials Phases Phase I trials test if a new treatment is safe and investigates the best way to provide the treatment Phase II trials test if one type of the disease responds to the new treatment better than another type; looks for effective dose and timing Phase III trials test if a new treatment is better than the standard (currently used) treatment and looks for rare side effects Phase IV trials find more information about long-term benefits and side effects of the already approved treatments 7 Vaccine Development 8 https://www.ncirs.org.au/phases-clinical-trials Vaccine Development https://www.ncirs.org.au/phases-clinical-trials 9 Group Activity: 10 - Sort the 10 cards into the order required to develop a new medical treatment. - Identify Phase 1, 2, and 3 of the Clinical Trial. 11 Group Activity Key: 12 Any questions? - Post on the StudyDesk forum (if you have question, someone else will too!) - Can also email [email protected] 13 14