adequate and well controlled trial
- Guideline or reference source
- ICHE5(R1) Ethnic factors in the acceptability of foreign clinical data
- Definition
- An adequate and well controlled trial has the following characteristics: • a design that permits a valid comparison with a control to provide a quantitative assessment of treatment effect; • the use of methods to minimize bias in the allocation of patients to treatment groups and in the measurement and assessment of response to treatment; and • an analysis of the study results appropriate to the design to assess the effects of the treatment.
- Used For
- adequate and well-controlled study
- Related Term
- clinical trial design
- exploratory studies
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