Dr C.K. Wang on How Real-World Data Provide a More Comprehensive Picture of Drug Efficacy
Real-world data offers a glimpse into what happens to patients treated by real-world doctors under real-world circumstances, explained C.K. Wang, MD, senior medical director, COTA.
Transcript With limited patient populations involved in clinical trials, how can real-world data provide a more comprehensive picture of a drug’s efficacy?
There are many fundamental differences between clinical trial data and real-world data, or RWD. Clinical trial data essentially is the result of well-controlled scientific studies, and the patient that typically enrolls on a clinical trial is generally younger, more fit, and whiter than the general population. The real-world data, on the other hand, is essentially a glimpse into the information that currently exists in every provider’s office, and it constitutes patients from all ethnic backgrounds, socioeconomic status, and it gives us a very comprehensive view of what happens and essentially is a glimpse into what happens to patients treated by real-world doctors under real-world circumstances.
This insight that real-world data can give is very valuable or can be very valuable to life sciences companies in their attempts to help accelerate drug discovery and approval, as well as to monitor real-world treatment outcomes and treatment-related side effects. I think the best example of this is the most recent FDA approval, actually from yesterday, of a drug to treat a specific subtype of male breast cancer, which is a very rare cancer, and the study that led to this drug’s expanded approval essentially used real-world data in its study design. I think going forward, real-world data will be used more frequently to help life sciences companies to help accelerate their attempts to drug discovery and drug approval.