Institutions and their investors appear to be banking on continued growth in clinical research—in particular, in terms of decentralized clinical trials (DCTs)—being a healthy trend, if recent announcements of significant new funding for development of a DCT software platform by one company and of a major expansion into trial services by another are any indication.
Series A funding of $15 million was announced today for Curebase’s ongoing work on its DCT platform and virtual research site capabilities, led by GGV Capital with participation from Xfund, Bold Capital, and several other institutional funds, bringing the total raised by the firm to $19 million.
Meanwhile, CVS Health last week announced the creation of a “new Clinical Trial Services business that brings together innovation and experience to help solve” challenges in recruiting and retaining patients for studies, “driving greater access to clinical trials across the communities it serves and creating a more efficient, convenient experience to improve participant retention and research effectiveness.”
According to Curebase’s announcement of the new funding, current DCT companies “have focused on narrow pieces of the problem, like incorporating wearables,” whereas it seeks to enable “complex studies that can be done completely around the patient’s lifestyle”—both at home and in real-world settings.
The company notes that, after the COVID-19 pandemic struck in early 2020, a large swath of clinical trials had to be halted, costing some of the largest pharmaceutical companies hundreds of millions in operational and commercial losses due to the inability to bring drugs to market as planned. However, the U.S. Food and Drug Administration issued guidance in March 2020 that set the groundwork for the broader adoption of more patient-centric studies, in order to ensure trial continuity. In this environment, Curebase and others aim to “make trials not only more patient centric, but faster and more cost effective,” the company explains.
Curebase says it has a dozen clinical studies using DCT research methodologies currently under way, and “research where any patient can sign up at home and collect data whenever they go to their own doctor.” During the pandemic, it “operated six different COVID-19 studies using community-based pop-up drive-through testing sites across the country, turning them into clinical data collection machines at scale with incredible patient diversity,” the company notes.
Also beating the drum for expanded access to trials, CVS Health says its Clinical Trial Services is “working with key stakeholders in the biopharmaceutical industry and across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation.” The new business will initially focus on:
- Precision patient recruitment—Leveraging analytics, national reach, and local community connections to engage individuals by helping them learn about clinical trial opportunities that may be appropriate for them.
- Clinical trial delivery—Innovative, decentralized options for the delivery of Phase III/IV clinical trials and real-world evidence studies at CVS locations, at home, or virtually.
- Real-world evidence generation and studies—Retrospective and prospective studies that measure the impact of novel devices and therapeutics in real-world settings.
Having also helped the pharmaceutical industry facilitate studies of investigational COVID-19 treatments and vaccines, CVS says it has already built expertise in clinical research through “more than 200 in-home clinical trials, real-world evidence studies, and support for publication of peer-reviewed articles.”
Edited by Gary Cramer