[1] In the USA the 21st Century Cures Act required the FDA to expand the role of real world evidence.
[2] Real-world evidence comes into play when clinical trials cannot really account for the entire patient population of a particular disease.
Patients with comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment in question as expected.
RWE provides answers to these problems and also analyzes the effects of drugs over a longer period of time.
In the primary healthcare setting, poor quality data can lead to poor patient care, negatively affect the validity and reproducibility of research results and limit the value that such data may have for public health surveillance.