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. 2019 Feb 13;10(Suppl 1):1–13. doi: 10.1007/s13300-019-0573-y

Table 2.

Differences between randomised controlled trials and real-world studies

Randomised controlled trials Real-world studies
Quantifies efficacy of drug Measures effectiveness of therapy; includes health outcomes and resource utilization
Interventional Primarily observational
Comparison to gold standard or placebo Comparison to standard clinical practice
Double blind/open label Open label
Restrictive inclusion/exclusion criteria Broad inclusion/exclusion criteria
Adherence encouraged and monitored Set in normal care setting
Frequent study visits No extra visits
Drugs provided Drugs prescribed and collected in normal way