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Clinical Trial Stages:
Clinical Trial Stages:
Assess drug for side effects
Assess drug for effectiveness
Compare drug to known alternatives
Assess long term safety
Post authorisation
Post authorisation safety study (PASS) is an observational study assessing for side effects once in clinical practice- looking at those who may not have been included in the trials, e.g. the elderly.
Intention to treat analysis
Appropriate for RCTs with high drop out rates
Includes outcomes of those who withdrew according to their original assigment
Written 2024
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