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Clinical Research Management 512

Clinical Research Management 512. Leslie McIntosh l mcintosh at path.wustl.edu. Graphs. Part 2. Types of Clinical Research. 1. Case Reports Anecdotal  Problem 2. Observational a. Case Control/Retrospective (lung cancer) b . Cross Sectional (WESDR) Beaver Dam

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Clinical Research Management 512

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  1. Clinical Research Management 512 Leslie McIntosh lmcintosh at path.wustl.edu

  2. Graphs

  3. Part 2

  4. Types of Clinical Research 1. Case Reports Anecdotal Problem 2. Observational a. Case Control/Retrospective (lung cancer) b. Cross Sectional (WESDR) Beaver Dam c. Prospective (Framington) WESDR-II Risk Factor Associations 3. Drug Development (Phase 0, Phase I, & Phase II) Dose and activity 4. Experimental (Clinical Trial) Phase III “Effect”

  5. Primary Interests • Exposures – what affected the person intentionally (intervention) or not • Outcomes – what happened to the person • Clinical measures • Non-clinical measures

  6. Activity Exposure Outcome

  7. Erroneous Conclusions Correlation is not equal to causation; it is only a requirement for it.

  8. Erroneous Conclusions • Young children who sleep with the light on are much more likely to develop myopia in later life. • Published from U of Pennsylvania Medical Center in the May 13, 1999 issue of Nature, the study received much coverage at the time in the popular press. • A later study at The Ohio State University did not find a link between infants sleeping with the light on and development of myopia. • It did find a strong link between parental myopia and the development of child myopia, also noting that myopic parents were more likely to leave a light on in their children's bedroom

  9. Erroneous Conclusions • Correlation does not prove causation

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