What is real world data?

Real world data is a term to describe data coming from patients directly. In medical research real world data helps to understand a patient’s wellbeing, both physically, socially and mentally. Real world data can be generated from questionnaires or from wearables.

The Food and Drug Authority (FDA) in the United States developed a program that focuses on Real World Data and Real World Evidence in 2018. They define Real World Data as follows: “Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.”

The bigger picture

Real world data is strongly related to bigger trends such as Real World Evidence (RWE) and Personalized Medicine. A trend that is already happening is that ‘one size fits all’ medicines and treatments are being replaced with personalized therapies and treatments. In 2018 42% of all new drug approvals in the United States were personalized medicine approvals (source). 

Personalized medicine will allow doctors to prescribe medicines and treatments based on a patient’s specific physical condition and history. In order to make an evidence based decision a significant amount of research data has to support the conclusions. Randomized Controled Trials (RCTs) are the golden standard for developing and testing new medicines and treatments. In most cases they use hundreds or thousands of participants to see if there are any adverse effects that occur due to the new medicine or treatment. Real World Evidence extends these tests in two ways: first, participants will be monitored after the approval of the medicine. So more data generated is a longer period. Secondly, more participants could join the research. This combination will create more data for a larger group over a longer period in real world scenarios. This generated data is called Real World Data. 

The benefits of Real World Data

1. Real world scenarios provide a more realistic simulation than randomized controlled trials as the diversity and combination of the participant’s physical, social and mental history will be more diverse.

2. Adverse effects might only be noticable over longer periods and therefore be missed in limited trials.

3. Manufacturers of medicines or treatments can provide doctors with more accurate, proven and up to date evidence about how to use the medicine or treatment. 

The history of real world data

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What is the difference between real world data and PROMs?

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