The Rise of Real-World Data and the Debate Over Its Role in Shaping Medical Research

Randomized controlled trials (RCTs) have long been regarded as the gold standard for evidence-based medicine. However, in our increasingly digital world, a new contender is emerging, vying for the top spot. Real-world evidence (RWE), derived from data sources such as electronic health records, patient registries, and wearable devices, offers a promising alternative to traditional clinical trials. Proponents argue that RWE can provide valuable insights that are difficult to obtain through conventional RCTs. Nevertheless, the shift towards RWE has sparked a debate among experts, with concerns about abandoning RCTs and the potential risks associated with relying solely on real-world data.

There are several reasons why researchers are turning to RWE as an alternative or complement to RCTs. In cases where RCTs are not suitable, such as rare diseases, complex technologies, or specific populations, RWE can fill the knowledge gaps. For example, running RCTs for the various conditions medicinal cannabis is used for is deemed nearly impossible due to patient comorbidities and longitudinal outcomes that are essential in assessing its value. Moreover, as the era of blockbuster drugs for large target populations wanes, RCTs become impractical for developing treatments for niche populations. The evolving landscape…