Innovation in behavioral health has long been limited by a lack of available data to support evidence-based decision-making. This lack of data can be attributed to many factors. Some of these factors are impossible to change, such as the heterogeneity of how the same diagnosis presents differently from patient to patient. Others could be changed but not without cooperation across behavioral health stakeholders; for example, a lack of consensus regarding how to define patient improvement, in addition to which tools to use to measure improvement, has resulted in a lack of standardization unseen in other areas of health.
The Hol Picture
Our Insights on Real-World Evidence and Behavioral Health
Alex Vance is Holmusk's Senior Vice President of Data Strategy and Operations. He's worked at the intersection of clinical research, clinical practice, and tech-enabled solutions for the past 15 years. Prior to that, he worked as a mental health counselor and researcher.
This is an excerpt from a longer post that originally appeared on Going Digital: Behavioral Health Tech.
Real-world data (RWD) are becoming increasingly critical to clinical research. The FDA has put forth definitions surrounding RWD, as well as issued guidance around its use in research emphasizing the principle of data being “fit-for-purpose”—selecting the data needed to answer the question at hand. Meanwhile, stakeholders engaged in clinical development have increasingly recognized that RWD will enable them to conduct studies faster, at a lower cost, and often, with a more representative and diverse population.
However, not all RWD is fit-for-purpose—that is, captured and stored in such a way that the data is ready to address the question at hand. In order to move forward with using RWD in a way that is efficient and effective, we need to build a shared understanding of the different types of data within the broad umbrella that is RWD and make clear which type of RWD is fit-for-purpose for a specific question.
As a mental health clinician and researcher, I have seen firsthand how our understanding of the role that biological and socioenvironmental factors play in mental health has evolved over time. For many years, the debate over nature vs. nurture dominated discussions in the field, but more recent models have focused on the interaction between genes and the environment, such as the diathesis stress model.
I recently had the pleasure of joining Real-World Wednesday, a conversation hosted weekly on Clubhouse covering various topics about real-world data. First off, I’d like to thank the hosts of the RWD-RWE Club, Matt Veatch and Aaron Kamauu, for the invitation and the engaging discussion.
At Holmusk, our vision is to provide fit-for-purpose real-world data that fuel research and innovation in behavioral health. With tons of data captured each day as patients move through healthcare systems—much of it in unstructured data fields—a lot goes on behind the scenes, as we ensure that this information is available and usable for research. Below, you’ll find a quick overview on the types of data that are included in the NeuroBlu Database—as well as the process data go through to ensure they are fit-for-purpose.
Earlier this month, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its annual National Survey on Drug Use and Health (NSDUH), which examined substance use and mental health data from 2021. Although the survey has been administered since 1971, SAMHSA called this year’s “the most comprehensive report on substance use and mental health indicators” that the organization has released to date.