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Clinical Trials (Steps in conducting research (Formulate research question…

- - - - confirm main action (if possible)
  - - - A control is needed
        for the new drug
        
        placebo dose
        
        degree of induced placebo varies with the route of administration
      - bias avoidance
        
        randomization
        
        allocation of the new drug or the control to an individual patient is unequivocally random
        
        Double blind study - neither the patient not the physycian know, which one is the drug and which is placebo
      - assessment
        
        objective measurement of the drug effect
        
        subjective assessment - quantified by
        use of visual analogue scales
        
        especially effects measurement of mental disorders
        
        clinical significance
        
        drug is clinically signficant if it
        improves the conidition about 30-50%
        
        not the same as statistical significance
        
        data exclusions
      - types of trial design
        
        concurrent (parallel)
        
        Cross-over
        
        enriched design