Real World Data
Real-world data (Real-world data) is data related to human health obtained in daily life. For example, data from medical records (medical charts), prescriptions, and wearable devices are called real-world data, and are used in a wide range of fields, including research and development of drugs, public health, and health economics.
Real-world data includes the following
On the other hand, randomized clinical trials are not real-world data. Randomized clinical trials is a useful way to compare, for example, a new drug with a standard drug to determine which is more effective or safer, without bias. However, clinical trials can only be evaluated under certain limited conditions. For example, the safety of participants is paramount in clinical trials, so elderly patients or patients with complications may be excluded, or only patients with severe illnesses may be included in order to evaluate the effectiveness of a drug with a high degree of accuracy.
Real-world treatments are given to patients with different characteristics in a variety of healthcare settings. For example, even if there are no patients over 90 years old in a clinical trial, there are in fact many patients over 90 years old. In such cases, real-world data from patients using the drug in daily practice can be analyzed to provide a more realistic evaluation. However, real-world data can only be used for Randomized Clinical Trials like randomized clinical trials, in which drugs are randomly assigned and their effects cannot be fairly compared without bias. Therefore, we compare drugs using methods of trial design and data analysis known as epidemiology and statistics to remove bias as much as possible.
In addition, we compare a breakthrough new drug with a placebo (a drug that looks and tastes like the drug but does not contain the active ingredient) in patients suffering from rare or intractable diseases for which there is no cure Randomized Clinical Trials is conducted, it may not be ethically acceptable for patients to be assigned to a placebo, as many patients prefer the new drug. In such cases, real-world data can be used in place of placebo information, creating the possibility of evaluating new drugs without giving patients a placebo.
Furthermore, real-world data are used for purposes other than comparing the effects and side effects of drugs. For example, collecting and analyzing data on daily life from wearable devices has been useful for various purposes, such as examining whether the quality of patients' activities has improved, or examining the actual status of treatment and the burden of medical costs.