Real-world evidence has been increasingly recognized as an important complement to clinical research. In clinical research, randomized controlled trials often have stringent inclusion criteria which may exclude certain patient groups, such as those with comorbidities. When clinical trial populations diverge from patient populations seen in a real-world care setting, insights gained might not be widely applicable to all people. Analyzing real-world data, such as clinical information recorded in electronic health records (EHR) as part of routine clinical care, can provide insights that are generalizable to real-world populations.
The Hol Picture
Our Insights on Real-World Evidence and Behavioral Health
As biopharmaceutical companies and regulatory bodies look toward adopting EHR-derived real-world data to complete studies more efficiently and affordably, one major concern that often arises is what has come to be known as “data missingness.”
Imagine that you are a therapist seeing a new patient for the first time. The patient says that while she has no history of clinical depression, she has been feeling really sad lately and has lost interest in the things she normally enjoys, such as cooking and creating new recipes.
When you start to ask questions, however, you begin to uncover the factors that may be impacting what your patient is currently experiencing. She tells you she has recently moved across the country and has had trouble finding a new community where she feels connected. Because she feels so sad most of the time, she has stopped calling anyone from her previous home, telling you that she “doesn’t want to bring them down.” You hypothesize that the recent drastic changes in her environment may be contributing to the symptoms of depression she describes.
What if we could better understand the effects of treatments on specific types of individuals, thereby allowing us to personalize drug treatments?
Clinical Trials Day: How we can leverage RWE for continued improvements to the behavioral health clinical research ecosystem
On Clinical Trials Day, we recognize an important part of the healthcare infrastructure: the studies that rigorously evaluate new treatments to determine which will be effective and safe for improving patient health. Through the conventional process of assessment, the treatments that succeed will go on to regulatory approval and will be marketed to patients and their providers.