Last time we discussed Patient-Reported Outcomes (PROs), and now it’s time for another very important concept for PolNor: Real-World Evidence (RWE).
First, some context. Evidence-based medicine generates valuable data through systematic controlled clinical trials. For example, a new drug or an upgraded medical device can benefit from randomized controlled trials to generate data about their efficacy.
High-quality trials manage to cover a representative portion of a population and undoubtedly have contributed to the advancement of numerous forms of treatment.
However, there are limitations. For example, the overall population can be too large and diverse, making it impossible to select a representative sample. Alternatively, the observed effects may be too long-lasting, making it infeasible to follow the complete disease journey.
This is where the RWE comes in. Real-World Evidence involves the data generated outside of the controlled environment of trials. This information is used by pharmaceutical companies, researchers, and others to advance healthcare in many ways.
Extending our example: a patient that takes the new drug develops a cold, and so goes to the hospital for treatment. He is cured and the doctor orders tests to investigate if there is any relation between the new drug and the cold.
Is this data RWE? To be precise, it can be RWE - if the hypothetical hospital has the right tools and procedures. Imagine if the facility uses paper records and doctors don’t take notes. As soon as the patient leaves the premises, the potential data is lost.
While this example is extreme, unfortunately, the result of “potential data being lost” is still very common. In order to be useful, the patient and treatment data must be created properly and stored in a standardized way so it can be transferred to the relevant database.
From the medical facility's point of view, this requires good tools and training. From a broader point of view, a centralized database is necessary.
In our next text, we’ll show how PolNor makes use of the best tools available to help Rheumatological treatment in Poland generate first-class Real-World Evidence while building a pioneer registry.
