REAL-WORLD DATA VS. REAL-WORLD EVIDENCE
In 2016, the Food and Drug Administration (FDA) passed the 21st Century Cures Act in effort to incorporate more patient perspectives and expand the approved types of data that can be used to support regulatory drug development decisions. The Cures Act is a step towards improving the FDA’s capability to streamline clinical trial designs and clinical outcome assessments, which includes the use of real-world data and evidence.
The FDA defines real-world data* as “the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” This can include data from the following sources:
- Electronic health records
- Insurance billing and claims
- Product and disease registries
- Patient-generated data (e.g. patient-reported outcome measures or surveys)
- Biometric monitoring devices (e.g. mobile phones or watches)
The Cures Act additionally provides guidance on the use of real-world evidence*, which states it is “the clinical evidence regarding the usage and potential benefits/risks of a medical product derived from the analysis of RWD.” RWE is essentially the analytical data which details the use, potential benefits, or risks of a drug obtained from non-traditional clinical trials such as:
- Randomized controlled trials, or RCTs (including large simple trials and pragmatic trials)
- Observational studies (prospective and/or retrospective)
With the use of RWE, the FDA has better understandings on how to best design and operate clinical trials/studies in healthcare settings to resolve unanswered questions and improve treatments.