What does this survey represent?
The survey reveals that an impressive 90 percent of life sciences companies are actively embedding rich, multi-source, real-world data (RWD), including EHR data, claims, and patient-reported outcomes, into their innovation life cycles to support faster, more efficient, and safer research and development.
More than two-thirds agree that recent RWD breakthroughs, prompted by greater investments, have reduced the time it takes to generate actionable insights. Expanded access to these high-value data assets is also critical for enabling the use of new data science methods, such as artificial intelligence, to understand disease progression, observe patient behavior, and fill clinical trials quickly and effectively.
As adoption increases across the clinical research ecosystem, RWE has now reached the point of being a “true end-to-end capability” for life sciences companies, the report declares, and the biopharma community appears to be in complete agreement. By the end of 2020, 90 percent of all new drug approvals in the United States had RWE as a component of their submission!
This includes a regulatory submission, the first cell-based gene therapy for patients with relapsed refractory multiple myeloma. Deloitte points out that during the phase 2 single-arm trial for the therapy, the pharma company worked closely with COTA to build an external control arm (ECA) using real-world data. The ECA was instrumental in expediting approval for the drug, which is designed for patients who have previously failed at least four lines of therapy.
Success stories like this are just the start of what RWD and RWE can do for the life sciences, and companies are now fully aware of how much potential awaits them. Over the next two to three years, more than half of survey respondents are planning to increase use of RWD and RWE for designing trials, supporting label revisions, creating ECAs, working more closely with clinical care providers, and enhancing patient follow-up capabilities.
To make the most of real-world data, life science stakeholders should develop an enterprise-wide strategy for investing in beneficial partnerships with RWD companies, integrating new data assets into the drug development lifecycle, and implementing a governance framework around the use of RWD and RWE for regulatory submissions, the report advises.
It’s important to be both bold and agile in this new data-driven world, Deloitte urges. Shrewd investments in a strong foundation across the enterprise will pay dividends in the near future as RWD helps companies launch more cost-effective, better designed clinical trials, monitor patient safety and outcomes more robustly, and seamlessly work with regulatory agencies to accelerate approvals.
At COTA, we’ve known since the beginning that RWD and RWE would change the game for the life sciences industry – and for the cancer patients and families who rely on cutting-edge therapies to extend their lives and improve their cancer journey experiences.
Our mission has always been to equip life science companies with deep, broad, reliable, expertly curated RWD, and we are thrilled to see regulatory agencies and pharmaceutical partners across the industry are fully embracing RWD and RWE as part of the investigational process.
There is so much more we can do with these valuable real-world datasets to support cancer patients and their families during an incredibly challenging time in their lives. The COTA team is beyond excited to be part of this building momentum, and we’re more than ready to keep exploring the untapped possibilities of RWD and RWE alongside our partners in clinical care and life sciences.