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Nuremburg Code
1st recognized code of ethics
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Examples of abuses of clinical trials
- Thalidomide and birth defects
- Sloan Kettering Institute
- Tuskegee sypillis experiment
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1974 National Research Act
- Establised IRB's
- Establised National Commission for Protection of Human Subjects
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1978 Belmont Report
- Set ethical principles and guidelines in research
- Need to consider the risks and benefits of human testing
- Need to obtain informed consent
- Subjects tested must be of sound mind
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Measures of Variability
How wide the observations are spread around measure of central tendency
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Range
Difference between largest and smallest value
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IQR
Spread of the middle (50%) of numbers
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Five number summary
- Minimum
- 1st quartile
- median
- 3rd quartile
- maximum
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Nuremburg Code Outlines
- Voluntary informed consent
- No unnecessary research
- Research should be preceded by surveys and animal experimentation
- Research protocol should be reviewed by scientifically qualified professionals
- Research should be stopped if subject is endangered
- Physical and mental suffering should be prevented
- Subjects are free to with draw at anytime
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Four Phases of Clinical Trials
- 1. Evaluate safetey, determine dosage, identify side affects
- 2. Evaluate safety, determine effectiveness
- 3. Collect more information about safe usage, confirm effectiveness, monitor side affects, compare to alternatives
- 4. Collect data on effect on specific groups, monitor long term side affects
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IRB
Institutional Review Board
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PHSC
Protection of Human Subjects Committe- SWOSU's IRB
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Components required for PHSC application
- Why the research is being done
- What the researchers want to accomplish
- What will be done during the trial and for how long
- What risks are involved in the trial
- What other treatments are available
- What benefits may be expected from the trial
- The fact that participants have the right to leave at any time
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IACUC
Institutional Animal Care and Use Committee
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Biosafety Committee
Ensure safety when using potentially infectious microbes in research
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Descriptive Statistics
Use data to describe sample
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Inferential Statistics
Use sample to make conclusions about the population
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Mode
The most common observation or category
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Pro's for Mode
- Easy to obtain
- Not sensitive to outliers
- appropriate for both qualititave and quantitative data
- Can use to predict the value or category of next observation
- Easy to explain
- Easy to present
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Con's for Mode
- May not be a clear mode
- May not be just one mode
- Does not provide us information about the entire distribution of data
- Sensitive to how to categorize information
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Mean
The average of the data
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Disadvantages using mean
- Can take on a fractional value, even if original data is discrete
- Best used for symmetric data, because is sensitive to extreme measures
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Median
Center of data when sorted into an array
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Advantages of Median
- Relatively easy to obtain
- Can always obtain a median versus mode
- Is based on the entire distribution of data versus mode
- Not influenced by extreme values versus mean
- Appropriate for quantitative and ordinal data
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Mean = median
Symmetrical
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Mean > median
right skewed
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Mean < median
left skewed
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If you have skewed data, what measure of center is going to be affected?
mean
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Trimmed mean
Drop top and bottom values
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Winsorized mean
Change 5% to less extreme value
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Quartiles
25,50, and 75% Q1,Q2,Q3
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Find outliers by making imaginery boundaries using:
Q1-(1.5*IQR)
Q3+(1,5*IQR)
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Variance
- s^2
- sigma squared
- Never negative
- Accounts for each observation
- can be affected by outliers
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Standard Deviation
- Square root of variance
- same units as original data
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Coefficient of Variation
- s/mean*100%
- Can compare to different types of data by eliminating the units
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