As a relatively new means of conducting research in the life sciences, RWE, or real-world evidence, is data that comes from “real world settings” such as a clinical practice. Studies driven by real world evidence, or real-world data (RWD), can utilize data from medical records or claims databases, be conducted prospectively in observational studies or adhere to a mixed, hybrid-design approach.
Thus, RWE does not originate from the tightly controlled environment of clinical trials; instead, RWE replicates the same behaviors one would see in a real-world setting or typical clinical practice. In fact, one could say RWE provides essential insights on a range of outcomes that are representative of an everyday clinical setting, while randomized clinical trials provide efficacy and safety and are crucial for product registration.
In the context of drug development, the Phase 1-3 clinical trial phase is where researchers study whether or not a drug is safe, effective and does what it is intended to do–make people better. As the clinical trials progress, more patients are added in each phase, more evidence is collected to prove the drug is safe and effective, then the clinical trial data is presented to a regulatory agency and hopefully receives a stamp of approval to be placed on the market. Once this occurs, doctors start prescribing the drug to their patients, which is where the bulk of RWE is produced, as the data on the new drug is recorded in medical and claims records as well as through patient experience surveys.
RWE studies are then conducted to answer a variety of questions that were not answered in the clinical trial setting: How do patients actually adhere to the drug regimen? Is the drug prescribed in other indications? What is the real cost of the product to the patient and healthcare system? RWD can also be used to improve future clinical trials by informing researchers of the populations most likely to benefit from product regimen or to identify additional outcomes to assess.