What is Real World Evidence

This relatively new practice has proven to greatly enhance the quality and effectiveness of clinical studies. 

What is Real World Evidence?

According to the FDA, Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of Real World Data. Our take, and as the name suggests, Real World Evidence refers to data collected from the real world instead of the randomized controlled trials. Real World Evidence services study real patients and the outcome of their treatment. This Real World Data is collected and analyzed from from a variety of sources, such as patient registries, electronic health records, insurance claims databases, patient research networks, medical billings, etc. This data provides a complete view of the actual use of a product, its effectiveness, and related adverse events in a real medical setting. RWE takes this data and provides clinically-rich insights into what actually happens in everyday practice and why. This knowledge is used to support decision-making and improve safety and effectiveness, and ultimately, patient outcomes.

 

What is Real World Data?

So what, then, is considered Real-World Data (RWD)?  RWD is data that is routinely collected from ongoing patient care or health status. This data can be collected from a variety of sources, such as patient registries, electronic health records, insurance claims databases, patient research networks, medical billings, etc. As mentioned above, this data provides a complete view of the actual use of a product, its effectiveness, and related adverse events in a real medical setting.

 

What is the difference between Real World Evidence & Real World Data?

In essence, Real World Data is the data that is captured, so WHAT happened. Real World Evidence are the conclusions provided based on analyzing the data captured.

 

What is the value of Real World Evidence?

Real World Evidence studies represent the collective experience treating millions of patients. As mentioned, RWE provides a complete view of the actual use of a product, its effectiveness, and related adverse events in a real medical setting. RWE provides clinically-rich insights into what actually happens in everyday practice and why. This knowledge is used to support decision-making and improve safety and effectiveness, and ultimately, patient outcomes. This relatively new practice has proven to greatly enhance the quality and effectiveness of clinical studies.

Examples of Value:

  • Real World Evidence becomes even more vital in cases where the usual clinical trial procedures don’t cover the entire patient populace of the specific disease. In other words, patients from remote geographic locations or age groups respond differently to the treatment as there was no representative in the trial group with a similar background to the patient. Real World Evidence helps tackle this type of problem.
  • Real World Evidence also studies the effects of drugs over a longer period of time than is possible through standard clinical trials.
  • Health Insurance companies and pharmaceutical companies greatly reduce their own financial risk with the help of real world evidence as it helps them understand their patients better and provide a better quality of drugs and treatment according to an individual’s specific needs.

Today, Real World Evidence is a driving force in the field of healthcare and research. Current trends and requirements indicate that this dynamic type of research is only going to grow. As a result, legislators and policy makers around the world like the FDA or Health Canada are getting more involved in its development and growth and use RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions.

 

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