Part 1. Real–world evidence vs randomised controlled trials

Although RCTs are regarded as the “gold standard” for medical evidence, they involve many restrictions that aim to isolate treatment effects from potential interfering factors (confounders) and that therefore distance the study context from the “real world” of the clinic.

RWE is an important complement to RCTs in order to provide a comprehensive understanding of the effects of a medical device or drug under real-world conditions.

What is RWE, and how does it differ from RCTs?

RWE comes from studies on clinical outcomes, patient outcomes and populations not typically covered by conventional clinical trials, such as randomised controlled trials (RCTs). The sources of RWE commonly include electronic health records, wearables, connected devices, medical claims, or registries for a specific product, disease, or group of patients. The key differences between RCTs and RWE are summarised in Table 1.

Table 1. A comparison between RCT and RWE

RWE, Symmetron and you

Symmetron recognises the importance of RWE for demonstrating and communicating the clinical and economic value of your medical device or drug to key stakeholders.
With this goal, we can help you with:

• Data identification: we can assess a wide range of real-world data sources to identify the most appropriate for your analysis.
• Data logistics: we have extensive experience with managing RWD logistics, including data transfer agreements and ethics approvals.

Stay tuned for part 2, where we will be discussing how RWE is used by different stakeholders!