The source and type of data used may also limit the ability to generalize the results and endpoints to the overall popul
REAL-WORLD DATA
LEARNING FROM ROUTINE CLINICAL SETTINGS.
WHAT ARE REAL-WORLD DATA (RWD)?
RWD CAN COME FROM A NUMBER OF SOURCES
RWD are information reported and collected from routine clinical settings. These data may be collected in one country or collected from all over the world. This type of data may include larger and more diverse patient groups that can complement clinical trial data, which come from well-controlled, randomized studies that evaluate pharmaceutical products in specific patient populations.
HOW ARE RWD USED? RWD can provide additional insight about a medicine’s effectiveness and safety profile. RWD studies can help explore additional research questions, complement clinical trial findings and fill gaps related to how a medicine is used in real medical settings.
RWD may help provide additional information about the effectiveness and potential side effects of a medicine for a particular approved indication.
WHAT ARE SOME OF THE LIMITATIONS OF RWD? Because patients evaluated through RWD are not randomized to treatment, this type of data is subject to potential patient-selection biases as well as additional limitations. The source and type of data used may also limit the ability to generalize the results and endpoints to the overall population. Therefore, RWD cannot be used as stand-alone evidence for treatment evaluation.
WHO MAY BENEFIT FROM RWD? RWD can provide additional information about a medicine that may not be available from clinical trials.
RWD MAY HELP KEY HEALTHCARE STAKEHOLDERS BETTER UNDERSTAND HOW A MEDICINE MAY WORK IN ROUTINE MEDICAL PRACTICE. THIS CAN BE ESPECIALLY USEFUL FOR:
PROVIDER AND PAYER ORGANIZATIONS – to increase their knowledge about the use of a medicine.
HEALTHCARE PRACTITIONERS – to inform their treatment decisions.
PATIENTS – to help discussions with their healthcare professional about their choices in care.
