![]() In that respect, it is already guiding clinical practice. 1,4-11 RWE is increasingly being used to support drug approvals 12 and in health technology assessments to support reimbursement. This evidence can be derived from real-world data from various sources, including electronic health or medical records (also referred to as EHR or EMR), patient registries, medical claims databases, retrospective or prospective observational studies or clinical audits (Table 1). Such data enable the generation of real-world evidence (RWE), which can complement information from RCTs by providing insights regarding the safety and effectiveness of an intervention in broader patient populations under routine care conditions. 3 This is where data collected from routine clinical practice comes in. ![]() In addition, RCTs can be extremely expensive to conduct and study enrolment can be relatively slow compared with non-randomised studies. ![]() ![]() However, since such studies often have strict inclusion criteria and stringent requirements for patient follow-up, they often have greater patient adherence than that seen in the clinic and can exclude some of the types of patients routinely seen in day-to-day practice. It is well accepted that randomised controlled trials (RCTs) are the gold standard in establishing the efficacy of a clinical intervention. ![]()
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