Real World Evidence provides access to valuable information about how patients respond to treatment in everyday situations. Data collected this way may differ from the results in the controlled environment of a randomized clinical trial. This means that real world evidence can be valuable source of information that was previously unavailable.
Real World Evidence – the beginning
Real world evidence (RWE) is clinical evidence that provides information on the possible benefits or risks linked with a particular drug, derived from RWD analysis. Thus, these are patient’s health and healthcare experience data extracted from various sources. Real world data comes from four categories (but these may expand in the future):
- Clinical data – refers to patient data has been extracted from electronic medical records (EMRs), and patient records that represent their treatment in the real world. These include lab data and other information from visits to all healthcare providers.
- Claims data – are administrative databases in the form of an electronic record that stores information about medical visits, bills, insurance information, and other patient-physician interactions.
- Digital health data sources – digital technologies are becoming more prevalent in our lives, allowing for new sources of patient health information.
- Patient-generated data – this is personal data representing the patient experience that is both collected and shared by patients themselves.
Real World Evidence – why is it so important?
The purpose of the research is to prove the positive effects of a drug or therapy under certain conditions. However, the number of patients is usually restricted only to smaller samples which means that the results cannot be generalized to other patients with similar diseases. RWE can significantly supplement the data that comes from conducting randomized controlled trials (RCTs). Each data collection option has its limitations in interpretation and in predicting value. The potential to provide a more accurate and complete picture of how, a newly introduced therapy will perform in the “real world”, advocates for use of not only RCTs but also RWE studies. Although RCTs are still considered the gold standard by physicians, they cannot provide a complete picture in every situation.
Real Worl Evidence from the use of smart inhalers
Smart inhalers are devices that may bring particular benefits for clinical researchers. Their use provides the opportunity to obtain real world data about participant’s health, habits, treatment adherence, or overall quality of life. FindAir tools for collecting RWE data with smartphones or smart devices in the form of an inhaler add-on make for the most comprehensive data source. With FindAir, data is gathered with minimal user action to provide complete and accurate data.
Read more: IoT with the use of smart inhalers
Real World Evidence – summary
RWE has stron potential to become an ongoing companion piece of clinical research. Healthcare providers are increasingly beginning to recognize the benefits of using RWE to supplement randomized controlled trials. It is an excellent tool to complement RCTs an can significantly influence the perception of some aspects of healthcare. Although some barriers are already visible. These can hinder the permanent introduction of RWE into clinical trials. The main barriers are: the qualitative variation of real world data or the limitation of access to RWE.