Real-world evidence (RWE) is evidence about the usage and potential benefits or risks of a medical product or technology, derived from the analysis and/or synthesis of real-world data (RWD).
RWE is created by addressing specific research questions through the scientific analysis of real-world data (RWD), rather than through randomised controlled trials (RCTs).
RWE complements RCTs to support the healthcare decision-making process. And while RCTs help to answer the question ‘Can this drug/technology work?’, RWE helps address the question ‘Does this drug/technology actually work in routine clinical practice?’
How is real-world evidence generated?
RWE is the result of analysing and/or synthesising RWD. Evaluating RWE for decision-making depends not only on the evaluation of the methodologies used to generate the evidence, but also on the reliability and relevance of the underlying RWD.
Analytics & methods
RWD is collected from a variety of sources, such as (electronic) medical records, health surveys, administrative claims, disease and/or patient registries, apps, wearables etc.
RWD from these sources is able to provide important information about patient experience and treatment implementation. However, in order to be used as evidence, relevant data must be analysed using the appropriate methods to address a specific research question.
Janssen and RWE
At Janssen, we use RWE in a transparent way and in collaboration with the scientific research community to complement the information we get from randomised controlled trials (RCTs). This allows us to make better-informed healthcare decisions and to improve disease understanding, thereby improving clinical practice and health outcomes for patients.
RWE helps us to:
Measure and better understand short- and long-term health outcomes
Capture, analyse and improve management of potential side effects
Understand healthcare practice and reduce costs to healthcare systems
Understand patient journeys in the real world, including key pain points
Shape our clinical development and early drug discovery plans
EHDEN is a federated network that aims to speed up the health research process. The idea is to revolutionise healthcare by harmonising data from 100 million records to the OMOP common data model.Learn more