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When do you use a surrogate endpoint?
When clinical endpoints are difficult or unethical to study (ex. MI's or death).
A way to analyze results that only includes data from participants who finished a study -
A way to analyze results that includes data from all participants who, at the very least, initiated treatment in a study.
- *This is considered the stronger method*
Which method (per-protocol or intention to treat) is considered the strongest? Why?
- Intention to treat.
- It has more external validity.
What considerations go into estimating the required number of patients in a study? (3)
- 1.) Size of effect that you are trying to detect.
- 2.) P-value
- 3.) Desired standard deviations from mean values?
What study recorded the effects of untreated syphilis in 600 black males?
The Tuskegee Study of Untreated Syphilis.
What is the Nuremberg Code?
- The first international code of research ethics.
- It was born out of the Nazi Medical War Crimes during WWII.
What are the 7 principles of the Nuremberg Code?
- 1.) Voluntary consent and freedom to drop out
- 2.) Fruitful results/benefits to society
- 3.) Based on previous animal studies
- 4.) Avoid all types of injury
- 5.) Risk of harm vs. humanitarianism
- 6.) Qualified investigators
- 7.) Study termination by investigators
What ethical code governs all research supported by the US government?
The Belmont Report.
What are the 3 basic principles of the Belmont Report?
- 1.) Respect for persons
- 2.) Beneficence
- 3.) Justice (fair inclusion/exclusion)