Unformatted text preview: amples of Trials Examples of Trials
Clinical trial: evaluates the occurrence of disease Clinical trial evaluates the occurrence of disease complications complications in cohorts of diseased persons assigned to different treatment groups
Example: Example: New New protocol to treat cancer Tamoxifen Tamoxifen to prevent recurrence of breast cancer Statins Statins to reduce cholesterol St Stents versus other kinds of surgery for heart disease ki di Vitamin Vitamin D to treat osteoporosis 6 Phases of Clinical Trials Phases of Clinical Trials
I: I: test new treatment in a small group of people: evaluate safety, dose range and identify side effects. II: II: test for safety and effectiveness in larger group group III: III: large study to compare new treatment to commonly used treatments commonly used treatments IV: IV: After : monitor effect in various populations and any side effects associated http://www.nlm.nih.gov/services/ctphases.html with longwith long-term use. http://www.nlm.nih.gov/services/ctphases.html 7 Examples of Trials Examples of Trials
Field Field trial: evaluation of a preventative intervention in healthy people healthy people
Example: Example: delivery of polio vaccines to uninfected individuals to evaluate its efficacy at preventing disease Community Community trial: assign exposure to groups of people (communities) rather than individuals
Example: Example: community fluoridation trials in the 1940s and 1950s to prevent dental carries (a type of field trial). Natural experiment: not a trial at all Natural experiment not trial at all
Example: Example: Dutch famine studies of prenatal nutrition and birth outcomes Federal Federal warning in 2002 of overuse of hormone replacement therapy and 10% reduction in incidence of breast cancer. 8 Data Data Collection: Experimental Experimental Design
1. 1. 2. 3. 4. Select study group Divide (allocate) study group into d treatment and control groups Apply intervention. Assess and compare outcome in com treated and control groups. 9 Time Time Tunne...
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This note was uploaded on 02/21/2010 for the course PH 150A taught by Professor Adams during the Spring '08 term at Berkeley.
- Spring '08