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Curriculum
Overview: |
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Presentation for Veterinarians |
Three follow-up lessons for Teachers |
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Clinical
Trial Process |
Data Analysis |
Clinical
Trial
Business |
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Objectives |
Not applicable for this module |
Students will be able to:
1. Explain the difference between preclinical research and clinical
trial testing.
2. Explain what a biochemical pathway is and why that helps in new drug
development.
3. Construct a concept map showing the relationships and processes in
pre-clinical trials and Phase I-IV clinical trials.
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Students will be able to:
1. Explain what is meant by randomized control test.
2. Design a make-believe experiment that is blind and then re-design it
so that it is double-blind.
3. Say how average values (or even median values) can mask certain
treatment effects.
4. Calculate average, median, and quartile distributions. |
Students will be able to:
1. Explain the role of businesses in the pre-clinical trial
process and the clinical trial process.
2. Explain what a CRO or equivalent “in house” organization is and what
it does.
3. Demonstrate an understanding of the problems encountered in
testing of new drugs and medical procedures. |
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Major Content |
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Pre-clinical and clinical trial processes
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Clinical
trial design and data analysis
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Instruction on how companies and their sub-contractors pursue clinical
trials, and instruction on creation and operation of CROs |
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Props,
special resources/ supporting material |
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1. PowerPoint, "Preclinical Trials"
2. Tutorial, "Clinical Trial Processes"
3. Worksheet, "Clinical Trial Process"
4. Poster board or large chart paper (computer concept mapping tool –
optional) |
Tutorial with the worksheet, "Clinical Trial Data Analysis"
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PowerPoint, "Clinical Trial Research"
Pre-requisite: the other two units in this module
Web resources given for CROs and business plans |
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Activities/
demos |
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Worksheet and student group project (creating poster illustrating
concept maps of the clinical trial process - good for a show and tell”
at a family night festivity) |
Tutorial, worksheet, graph (illustrating
skew or normal distribution and how distribution dictates the kind of
data analysis), discussion
of questions and implications |
Student group creation of a business plan for a CRO |
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Student
Assessment |
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Grade the concept maps and presentation. |
Grade the worksheet. |
Grade the business plan. |
