Real-world data (RWD) is an overarching term for data on the effects of health interventions (such as benefits, risks or resource use) that are not collected in the context of conventional randomised controlled trials (RCTs).
While definitions vary, RWD tends to be structured, in that it has ‘data models’ with data residing in a fixed field, for example in databases and spreadsheets. RWD has more in common with epidemiological data than big data, which involves large or complex unstructured data sets, such as data from social media. However, the term big data is sometimes used more broadly, also referring to more structured RWD.
RWD can be collected both prospectively and retrospectively from observations of routine clinical practice. Data collected may include, but are not limited to, clinical and economic outcomes, patient-reported outcomes and health-related quality of life.
Overview of RWD sources
RWD can be obtained from experimental studies, such as pragmatic trials, or from observational studies. The different study designs that can provide RWD are described on Generating Real-World Evidence.
Additional sources of RWD that may provide data on the effects of medicines but are not necessarily part of structured studies are listed below.
Table. RWD from existing sources
| Patient registries | Patient registries are organised systems that are used to prospectively collect, analyse, and disseminate observational data on a group of patients with specific characteristics in common. See Patient Registries |
| Healthcare databases including electronic health records | Healthcare databases, which may be systematic collections of electronic health records (EHRs), are systems into which healthcare providers enter routine clinical and laboratory data during usual practice. Healthcare databases can be used in ‘real-world’ (observational) studies to assess the benefits and risks, as well as the relative effectiveness, of different medical treatments. See Healthcare Databases with a Focus on Electronic Health Records |
| Pharmacy and health insurance databases | Pharmacy and health insurance databases are types of healthcare database systems that are set up by pharmacists or health insurers for billing and other healthcare administration and management, such as monitoring of healthcare service use. Data collected in these systems can also be used in medical research to assess the effectiveness of healthcare interventions in ’real world’ observational studies. See Pharmacy and Health Insurance Databases |
| Social media | Social media are internet-based websites and applications that enable users to create and share content or to participant in social networking. They can provide patient perspectives on health topics such as adverse events, reasons for changing treatments and non-adherence, and quality of life. See Social Media |
| Patient-powered research networks | Patient-powered research networks (PPRNs) are online platforms run by patients to collect and organise health and clinical data. See Patient-Powered Research Networks |