In clinical research, a tension has always existed between methods.
Traditional methods often are interventional, reliant on in-person patient evaluations, and geared toward the provider. In contrast, newer decentralized study methods are participant-centric by design and tend to focus on observational research, rich patient-reported outcomes, and feedback loops. The combination of these new digitally driven methods and the increased availability and interoperability of health data has created a burgeoning market for real-world evidence solutions for life science research.
With these new tools and technologies in play, our recently released white paper addresses how decentralized, real-world research can give pharmaceutical and life sciences companies a fuller picture of an individual’s health. Rather than the figurative “teaser trailer” that traditional research provides, virtually captured real-world data gives researchers a front-row seat for the entire movie – complete with days of objective, patient-generated vital signs data; rich patient-reported outcomes such as video or voice diaries; telehealth visit notes; and much more.
The facilitated collection of this data through solutions like Sharecare’s Smart Omix both responds to some of the pressing challenges facing pharma companies today – which include evolving regulatory expectations – and presents new opportunities for growth and asset development. The length of time and investment required to bring new pharmaceutical products to market is staggering, regardless of whether companies are developing new drugs, medical devices, or app-based digital therapeutics. Yet, gathering real-world evidence through a tool like Smart Omix is fast, enabled in part by the ubiquity of connected devices like wearables and smartphones.
With real-world evidence, pharma and life sciences companies also can streamline the development process and save costs by giving clinical researchers early, yet valuable insight into how the intervention will perform in reality, versus in theory.
The opportunities to acquire this data digitally can have a clear bottom-line impact for pharma companies, but also get to the heart of the mission of so many players in the ecosystem: developing products that truly meet the needs of entire patient populations – and that’s inclusive of individuals with high and low incomes, employed and unemployed, young and aging, and across ethnicities and gender identities. Digital reach – the ability to find and reach participants where they already are (i.e., their smartphones) – can bring all players in this ecosystem closer to that goal.
What we’ve created in Smart Omix is an all-in-one platform to enable this. As suitable as it is for small-scale feasibility and pilot studies, it’s just as ideal for rapidly designing and launching observational non-registrational trials and post-marketing surveillance. Built for researchers, by researchers, Smart Omix is empowering our partnership-driven efforts to optimize outcomes – from working with healthcare and pharma leaders to develop digital biomarkers to identifying optimal treatments for epilepsy patients with academic researchers.
Next week at the 2021 CNS Summit, we’re joining UCB to share one example of how this futuristic approach to studies is coming to life today; yet as this work continues, we look forward to sharing the promising results of these efforts powered by Smart Omix to improve healthcare for people everywhere.