What is Real World Data (RWD)?

RWD is health-related information that is collected as part of a patient’s usual healthcare. It may include information documented in electronic medical records, laboratory tests, imaging studies like X-rays and MRIs, drug prescriptions, medical claims and many other sources. RWD can be collected specifically for a study (Primary Data) or may be used after having been collected for a different purpose (Secondary Data). The data itself may be Structured (organized in a specific format) or Unstructured.

What is Real World Evidence (RWE)?

RWE are analyses of RWD conducted with adherence to strict patient privacy regulations, that provide insights into diseases and their treatment that are complementary to information provided by Randomized Clinical Trials (RCT).

How can RWE improve healthcare?

New drugs are almost exclusively approved based on the results of RCT. These studies focus on demonstrating whether or not the drug is capable of impacting the target disease. Therefore RCT typically exclude patients who have co-existing conditions that may complicate the ability to detect drug impact. Due to their expense and goal of obtaining drug approval, RCT are typically short-term studies, on the order of 2-3 years in duration.

However, once a drug is approved, it is likely to be prescribed to a wide population of patients with the disease and may well be taken for an extended period of time. RWE studies evaluate treatment in the usual care setting and can provide information about how well a drug works and how safe it is in both the short and long term, for the diverse group of patients for whom it is actually prescribed. This information can confirm RCT conclusions or alert physicians to situations where additional consideration is warranted.