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Validity is the extent to which the inference drawn from the study is warranted when an account is taken of the study methods, the representativeness of the study sample, and the nature of the population from which it is drawn .
There can be two validity issues specific to Randomized control trials, internal validity and external validity. Internal validity is a prerequisite for external validity and external validity is irrelevant if a trial's outcomes are not internally legitimate.
Internal validity - Internal validity is interpreted as the capability to appropriately attribute observed differences between groups of patients assigned to different interventions to the intervention under examination. Internal validity harms the quality of the evidence collected from a trial.
External Validity - The extent to which the outcomes of trials give a correct basis for generalization to other clinical situations is referred to as external validity. External validity refers to the ability of trial results to be extrapolated to the "real world" population. The results of many RCTs are not easily applicable to many patients because the conditions under which the studies are usually performed cannot be easily replicated in routine clinical practice.
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