In the past, pharmaceutical producers rely mainly on prospective randomized clinical trials to achieve product approval. With advances in technology and expansion in regulatory guidelines, researchers now acknowledge that real-world data can help streamline and improve the efficiency of clinical studies.
Real-world data or evidence (RWD/E) are data that come from sources other than traditional clinical trials. These include Electronic Health Records (EHRs), insurance billing and claims, patient-reported outcomes, biometric monitoring devices (such as phones and watches) and disease or medication/device registries.
Unlike randomised clinical trials that take place in controlled settings under selective conditions, RWD/E has the advantage of clinical implementation in a real-world environment. These data enable therapies under evaluation to be tested under real-world conditions, potentially benefitting a broader population. The use of RWD/E is also key in supporting the development of therapies for rare diseases where traditional "gold standard" clinical trial designs are not feasible due to the low prevalence of the disease. Increased awareness and understanding of the implementation of RWD/E helps in regulatory decision-making, particularly in circumstances where time is of essence such as a pandemic.
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