Lung x-ray on iPad
Now Enrolling: This lung cancer patient registry study by PrECOG aims to better understand an FDA-approved treatment
January 16, 2025
Lung x-ray on iPad
Now Enrolling: This lung cancer patient registry study by PrECOG aims to better understand an FDA-approved treatment
January 16, 2025

Real-world data 101: an overview

Most people today are familiar with—and have access to—their electronic health record (EHR), a digital collection of their medical information that is stored on computers at the hospitals and doctors’ offices where they receive care. EHRs contain information about a person’s health history, such as routine check-ups, diagnoses, tests, and treatment plans. They can be easily shared between physicians and across multiple healthcare settings. EHRs came into use several decades ago, and today, they are instrumental in improving the quality of patient care.

EHRs are also one of the most significant sources of real-world data, which is information (data) relating to patient health status and/or the delivery of health care. It is routinely collected from a variety of sources. Besides the EHR, other examples of sources include:

  • Health insurance claims and billing records
  • Surveys that involve large numbers of people
  • Disease and patient registries (databases that collect and store information about individuals diagnosed with a specific disease or condition)
  • Mobile health apps
  • Wearable technology such as pedometers and smart watches

Notably, data collected about patients as part of a randomized clinical trial are not real-world data. This is because clinical trials differ in significant ways from the real world.

Randomized clinical trials provide initial evidence for the safety and efficacy of treatments. Real-world data studies offer additional insights into the impact of these treatments in everyday practice.

When a new treatment is approved by the US Food and Drug Administration after a successful phase 3 clinical trial, it should then be studied in a larger, phase 4 trial that tracks its effectiveness and side effects over a long period of time. Often, this does not happen. This means doctors have an incomplete picture of the effectiveness of commonly used therapies in the real world.

One solution to help “complete the picture” is the use of real-world data to develop real-world evidence. This is clinical evidence about the usage and potential benefits or risks of a medicine or medical product that researchers discover by analyzing real-world data. Real-world evidence has the potential to show the same important information that a phase 4 trial would typically show, such as how well a new treatment works over time or if any new or long-term side effects emerge.

Common examples of real-world data studies include registry studies and observational studies. Registry studies collect information on individuals with specific diseases or conditions into a database. These studies can reveal disease patterns, treatment outcomes, and long-term safety and effectiveness of interventions. In observational studies, researchers simply observe participants and collect information or look at data that was previously collected.  


Learn about a new lung cancer patient registry study, PrE1702, which offers patients not enrolled in clinical trials an opportunity to join and help researchers better understand an FDA-approved treatment.

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