Real-world data (RWD) is data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.
RWD can be collected from a number of sources that are associated with health outcomes in a heterogeneous patient population in real-world settings or non-randomized controlled trial settings rather than data collected in randomized controlled trials.
Sources for RWD can be categorized as:
- Clinical data, such as from observational studies, electronic health records (EHRs) and patient registries
- Administrative/claims data such as claims and billing activities
- Patient-generated data, e.g. in home-use settings, wearables and online communities
- Emerging/non-traditional, e.g. social media
The term real-world evidence is closely related to real-world data. RWE is developed from RWD by analyzing the accumulated data.
Value of real-world evidence
RWE supplements data generated in randomized clinical trials and provides value in a number of different ways:
- RWE provides information about how a treatment impacts patients’ life outside the narrow confines of clinical trials.
- RWE can accelerate the drug approval process by supporting decision making. Especially in oncology RWE can shorten development times and get drugs to patients more quickly.
- RWD/RWE generally stem from a more diverse population than the one selected for clinical trials and therefore can provide information about effectiveness and safety that cannot be gauged from randomized controlled trials. This information also provides valuable information for payers that gain a better understanding of the effectiveness of the drug and/or whether it improves health outcomes of specific patient groups.
The collection of real-world data, its analysis and transformation into real-world evidence is still in the early stages but its importance is increasing.