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Real World Evidence

What is real-world evidence?

What is real-world evidence?

What Is Real-World Evidence?
  • 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).[1]

  • RWE is created by addressing specific research questions through the scientific analysis of real-world data (RWD), rather than through randomised controlled trials (RCTs).[1]

  • 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.[1]


Research questions






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.[1]

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:[1]

  • 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

RWE partnerships 

We see a huge opportunity for RWE to bring about crucial changes in healthcare, if we can find ways of working together on a larger scale. We think RWE has the ability to help create efficient, personalised and learning healthcare systems that are focused on patients.

One of the biggest challenges in RWE is finding high-quality data sources. Health systems are often fragmented due to differing levels of investment in data platforms.[1] That’s why we have invested in a range of initiatives, including HONEUR (Haematology Outcomes Network in Europe) and EHDEN (European Health Data & Evidence Network), both of which are dedicated to optimising Europe’s health data collection landscape.

Partner with us


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