Drug Info Final 1

  1. When do you use a surrogate endpoint?
    When clinical endpoints are difficult or unethical to study (ex. MI's or death).
  2. A way to analyze results that only includes data from participants who finished a study -
  3. A way to analyze results that includes data from all participants who, at the very least, initiated treatment in a study.
    • Intention-to-treat.
    • *This is considered the stronger method*
  4. Which method (per-protocol or intention to treat) is considered the strongest? Why?
    • Intention to treat.
    • It has more external validity.
  5. 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?
  6. What study recorded the effects of untreated syphilis in 600 black males?
    The Tuskegee Study of Untreated Syphilis.
  7. What is the Nuremberg Code?
    • The first international code of research ethics.
    • It was born out of the Nazi Medical War Crimes during WWII.
  8. 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
  9. What ethical code governs all research supported by the US government?
    The Belmont Report.
  10. What are the 3 basic principles of the Belmont Report?
    • 1.) Respect for persons
    • 2.) Beneficence
    • 3.) Justice (fair inclusion/exclusion)
Card Set
Drug Info Final 1
Kill these suckas.