According to a story from BioSpace, there are times when new information is learned about a medication or therapy outside of the precisely controlled environment of a clinical trial. Such information is typically referred to as real-world evidence or real-world data. Often new data would appear as a surprise and this left the US Food and Drug Administration (FDA) in a position where it would need to respond to data as it appeared. However, at the recent Bipartisan Policy Center conference, FDA commissioner Scott Gottlieb presented a new framework that will allow the agency to address real-world data more effectively.
Collecting Real-World Data
Due to its diffuse nature, real-world evidence is often collected from a variety of different sources, such as health records, medical devices, insurance claims, lab tests, and more. During his address, the commissioner made it clear that the more conventional clinical trial environment was still valuable, but real-world evidence needs to be taken seriously and incorporated effectively into decisions regarding the regulation of medications.
Commissioner Gottlieb mentioned the possibility of decentralized trials that could utilize data from care facilities. Such an approach would allow patients to receive the treatment that they need from trusted community health providers without sacrificing the scientific integrity of the information being collected. Many studies of drugs after they have hit the market are lengthy and costly affairs and it may take several years before data from such a study is collected and ready for interpretation. The more effective use of real-world data could allow meaningful conclusions to be made at a more efficient pace.
Real-World vs Clinical Trials: Striking a Balance
The highly structured environment of the typical clinical trial is important for establishing controls and allowing researchers to be confident about the integrity of the information that they are collecting. With that being said, there are times when this environment can be so strictly controlled that it becomes unrealistic. This fact makes the data that is collected less useful. After all, when the drug enters the market there will be no constraints that will make a certain outcome more likely. Sometimes unexpected findings can appear once a drug enters the market.
Ultimately it is useful for both real-world evidence and data from clinical trials to be taken seriously. Looking at data from both settings can allow researchers to have greater confidence in their conclusions about the safety and effectiveness of a drug or therapy.
