Biopharma organizations are working to incorporate real-world evidence (RWE) throughout the product lifecycle, including to support research and development (R&D) and clinical trial recruitment. But before being able to generate these insights, teams need access to high quality sources of real-world data (RWD), which are fit for the purpose of answering their research questions.
Ian Rentsch, who recently joined Aetion as Vice President of Growth and Strategic Partnerships, aims to identify and collaborate with RWD organizations from around the globe—with an initial focus on Europe and Asia—to support biopharma and research partners in generating RWE.
Ian’s nearly three decade long career has spanned biopharma, clinical R&D, and global applications for RWE. He most recently served as CEO of Clinerion, a Switzerland-based RWD solutions company.
Here, Ian draws on his experience to share how RWD can support R&D, how data practices vary in different global markets, and how RWE collaborations across health care stakeholders can help generate the insights needed to get interventions to patients faster.
Responses have been edited for clarity and length.
Q: How can RWE support R&D, and what value can it add for clinical development teams?
A: In the last decade, the use of RWD and RWE has hugely impacted the health care and biopharma industries. More recently, the COVID-19 pandemic has helped accelerate the use of data and technology among biopharma and regulators.
From an R&D perspective, RWD and RWE have been used to support clinical trial planning and design; for example, RWD can help identify the right patient populations to recruit into clinical trials. Late phase clinical research has benefited most from the use of RWE, especially with retrospective studies and chart reviews. Essentially, RWD and RWE can help us plan studies with the end goal in mind of improving patient access to treatments.
Q: What kind of return on investment (ROI) can RWE platforms generate for R&D teams?
A: Using RWE saves time and costs in the clinical development process—and ultimately improves patients’ lives. So the ROI is great, especially compared to the long timelines and high costs involved with traditional clinical research.
This, of course, depends on the quality of the RWE, therefore employing regulatory-grade analytics and principled database epidemiology are key to realizing this ROI. For example, scientifically valid RWE can accurately predict the outcomes of randomized controlled trials, which normally take between 24 and 36 months to complete. External control arms made from RWD can support this work as well, and can help researchers imagine how drug performance in a trial compares to performance in the real world.
Q: What challenges exist to working with global RWD, and how can we address them?
A: Many of the “recipes” for applying RWE are universal, and are applied similarly in the U.S. and in Europe. The huge difference comes in practice; the European Union (EU) is made up of 27 countries, with many different languages spoken, cultures practiced, and health systems followed. This means the data is not standardized from one country to the next, and GDPR regulations have made access to data more difficult. This is a challenge in Asia as well, where data is even more dispersed and there’s an even wider range of languages, geographies, and health systems to navigate when attempting to standardize data regionally.
In order to realize the positive impact of RWE, it’s important to work closely with all stakeholders in the health care ecosystem: HTAs, regulators, biopharma organizations, and data providers. Collaborations across these distinct areas allow us to focus and agree on data standards across regions—which applies to the EU as well as to Asia.
Q: Now working at Aetion, which challenges are you most eager to tackle?
A: I look forward to supporting Aetion’s expansion into Europe, and eventually into Asia and other emerging economies, by sourcing global RWD sets that we can connect to the Aetion Evidence Platform® to generate RWE in a standardized way.
Sourcing and accessing RWD is a bit like finding grapes, and turning these into RWE is like making wine. The magic of Aetion is making great “wine” by applying our technology and regulatory-grade analytics to the data. I look forward to matching Aetion with great “grapes” from around the world, and making the best wine.