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What is Real World Evidence?

Real world evidence (RWE), is clinical evidence generated from medical and patient data collected during routine clinical care. These Real World Data (RWD) help to determine the effectiveness of interventions as they apply to all patients. RWD enable collection in all patients with a diversity of disease, co-morbidities and demographics that are often excluded in the context of randomised controlled trials (RCTs). RCTs in general help to determine the efficacy of an intervention, in a carefully selected cohort, rather than RWD which determines effectiveness in a normal population.

As such RWD and RWE are playing an increasing role in health care decisions:

  • Major regulators, like the FDA and EMA are developing guidance for the use of RWE pharmacovigilance for safety and adverse events, and to help make better informed regulatory decisions.
  • Health care providers are using the data to determine cost-effectiveness and more importantly to develop guidelines and decision support tools for use in clinical practice.
  • Medical product developers are using RWD and RWE to support clinical trial designs (e.g., large simple trials, pragmatic clinical trials) and observational studies to generate innovative, new treatment approaches.

Emerald's Care Model and Emerald's Data Platform have been developed to optimise the generation of real-world evidence to help inform the most appropriate use of the treatments to best care for our patients.

Listen to Dr Amy Abernathy, Principal Deputy Commission of the FDA, explain the importance of Real World Evidence.