Today, there is a real opportunity to design clinical trials to be user-friendly for participants. Research shows that clinical trial participants in the U.S. on average need to travel 50 miles to access research sites, and fewer than 10% of Americans participate in clinical studies.
Verily launched Baseline in 2017 to develop methods to make research more accessible to participants and to provide new insight into health and disease via a platform designed to collect multiple types of biological, clinical and sensor based data in collaboration with engaged participants and making the data more accessible for analysis. Our first initiative, the Baseline Health Study, was a landmark longitudinal study with the goal of better understanding health and disease through broad and deep data collection. To ingest, structure and gain insight from many different types of multidimensional data, we built the Baseline evidence generation platform.
Working closely with our partners in biopharma, patient advocacy, qualified healthcare systems, and academic medical centers, we have scaled the Baseline Platform into a powerful evidence-generation engine for accelerating scientific discovery. As a unified platform for clinical research, Baseline now enables better trial execution, data aggregation and analysis, and flexible study options for fully decentralized and hybrid trials. This week Verily’s Chief Medical and Scientific Officer Dr. Jessica Mega and Head of Clinical Policy Dr. Robert Califf sat down to discuss the next frontier of research at the virtual Future Trials conference. Here are the highlights from the conversation:
RC: Tell us about the evolution of the Baseline Platform and why Verily decided early on to focus on improving evidence generation, inside and outside the clinic.
JM: The Baseline Platform is really an end-to-end evidence generation platform that is designed to do two key things. One is to accelerate scientific discovery and also importantly, lead to improved clinical outcomes. The only way that you get a new medicine, device, digital tool, or even a new care pathway into the hands of clinicians and patients is through evidence. Now, what was really important to us as we started on this journey in 2017 was to start with a patient-centric point of view. To really do right by our participants, we knew we needed to build a digital platform to capture data and partner with them throughout their entire journey.
So we integrated new and novel ways of interacting with people, not just during clinic visits, but throughout their entire research experience. All of these capabilities were intentionally designed around the needs of participants, leveraging user-centered design principles from consumer software.
At the same time, we needed to do three additional things. To improve efficiency and enable decentralized and hybrid trials, we needed to create a unified digital system to conduct trials and eliminate siloed processes. Secondly, to create greater participation and retention, we came up with the concept of the Baseline community and registry, which allows participants to be part of that research experience.
And finally, we were deeply focused on capturing and analyzing real-world data. We built a suite of proprietary wearable sensors to capture clinical-grade novel data, as well as the infrastructure to gain insight from that data. So, that is what we've been up to over the last few years that's led to this important moment today.
RC: You touched on this idea of siloed processes and fragmentation. Fragmented data can lead to difficult interpretations and contradictory data in the same data set. What are we doing to solve that and improve data integrity?
JM: Data accuracy and integrity are front and center. Baseline was designed from the ground up to be a fully interoperable, end-to-end system. Once you start to harmonize various tools and technologies that underpin different participant interactions, the data sets start to come together. For sponsors, standardizing on a single system that can enable different types of clinical trials can simplify making that transition to hybrid and fully decentralized studies.
The COVID-19 pandemic has greatly accelerated the need for a decentralized and hybrid approach, and we’re incredibly proud that the Baseline Platform has served as the technology foundation for some of these efforts. One example is HERO-TOGETHER, an 11,000+ member COVID-19 safety surveillance study we created in collaboration with the Duke Clinical Research Institute (DCRI).
With support from the Patient Centered Outcomes Research Institute (PCORI) and in collaboration with the DCRI, we created the HERO Registry to engage with healthcare workers — before there were even therapeutics or vaccines available — to understand the physical and the mental health of people at the front lines. Once vaccines were approved, we were able to quickly activate this registry and leverage many of the platform’s existing remote data capture capabilities to generate real-time evidence about vaccine safety.
JM: Rob, it's been so wonderful to be able to work with you and the whole Verily team on Baseline over the years, because I have learned so much from your dedication to thinking about research in a different way. So I wanted to ask you a question. What's the next big innovation that we should be looking towards?
RC: Three things have really fascinated me my whole career, but now is the time they’re within reach thanks to maturation of technology . The first is electronic health records. How can it be that we're capturing all this information for and about people to deliver their healthcare, and then when we go to do research, we start all over again and act like we never had any information? Now, the ability to aggregate electronic health record data, curate it, and get answers, is really an important element that's going to move along very quickly. And, I'm heartened by the ability of the digital infrastructure to help solve the data curation issue on a large scale.
The second piece, which we are very focused on at Verily, is the digitization of biomarkers. Our ability to measure deep biology at a lower cost, and apply techniques like artificial intelligence, to understand what we now call the “phenotype stack” to look from genes to proteins, to metabolites, tissues and organs, is going to unlock new avenues of research.
This also applies to medical images. Anything that is digitized now can be analyzed in a very different way. So whether it's a retina, the skin or pathology, we can now take advantage of digital technology to automate efforts and improve scale.
As we work toward clinical trial hybridization, we need to think about the integration of the complex healthcare ecosystem. What’s exciting is that technology is no longer the limitation. We need to optimize the direct interaction with research participants, take advantage of existing data in the healthcare system to advance knowledge that improves the outcomes and also improve the in-person activities of research sites, which will remain an essential cornerstone of the research system. In my view, this is what the Baseline Platform is designed to do. So I couldn't be more excited about this next phase as we work with people across the ecosystem to accelerate discovery.
To learn more about the Baseline Platform and Verily’s vision for transforming research, visit our website.