By Ed Miseta, Chief Editor, Clinical Leader
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For years the life sciences industry has heard about the benefits of investing in real-world evidence (RWE) and real-world data (RWD). According to a recent report from Deloitte, that investment may finally be paying off for companies that climbed onboard and have been building those capabilities.
Deloitte has been conducting benchmarking surveys on the use of RWE since 2017 and notes it has remained a C-suite strategic priority for companies. However, the realization of a return-on-investment has varied across companies. This year’s survey was the first to show a stratification of results from companies that invested in more mature capabilities from those that have far less mature organizational and technical capabilities. Across all companies, the survey shows a clear focus on using RWE to enhance the R&D process.
Heavy Adoption in Next Few Years
For those companies not using RWE, the time to act is now. Ninety-four percent of respondents believe RWE in R&D will become important or very important to their organizations by 2022. The biggest impact of RWE over that time will be in R&D, including regulatory filings, the design of value-based contracts, comparative effectiveness research, and augmenting clinical trial design. That represents a migration from how RWE is used today, which is primarily for understanding the burden of disease and unmet medical needs, and pricing and forecasting assumptions.
The use of RWE has not come without challenges. Seventy percent of respondents noted a lack of research-grade data is hindering their efforts to incorporate RWE into R&D. According to Deloitte, that finding emphasizes the importance of companies establishing strategic partnerships. The survey found that 80 percent of companies are entering into strategic partnerships to access new sources of RWD.
Investing in RWE will also require additional resources. The survey found almost all companies expect to increase their investments in talent, technology, and external partnerships to strengthen their RWE capabilities.
The Companies Reaping Benefits
Although the future is here when it comes to the use of RWE, the adoption of this technology varies widely across companies. While some companies have yet to see any returns, the companies with mature capabilities in place are realizing the value of their investments.
In looking at these “mature” companies, Deloitte noted several similar characteristics. First, the C-suite executives in those companies view RWE as a very important strategic priority, and their companies realized the impact of this technology in the newer application areas noted earlier. Those companies are seeing reduced clinical trial costs and trial failure rates as a result of using RWE. Those companies also entered into strategic partnerships to access new sources of RWD and built more robust centralized cloud-based platforms with comprehensive capabilities. Those capabilities include knowledge management and self-service analytics applications.
Deloitte notes that although some companies are further ahead than others, the entire industry has yet to realize the full potential of RWE in transforming drug development, commercialization, and reimbursement. Although the more mature companies have demonstrated that a strong foundation with centralized technology platforms is the first step, companies must also define a clear, enterprise-wide strategy for their RWE investments. The strategy should be inclusive of innovation pilots, a framework to measure ROI, and engagement with the health care ecosystem in new ways to elevate the impact of RWE.
A Thumbs-Up From Regulators
The FDA has not been silent on the use of RWE. In the past year senior FDA officials have made numerous statements regarding how RWD and RWE can be incorporated into regulatory decision-making. The agency also issued draft guidance on the use of RWE and RWD in May 2019. The EMA has also released a paper promoting the use of high-quality RWD in decision-making. The support of RWE by other organizations shows momentum continues to build for the expanded use of RWE.
Dr. Janet Woodcock, director of the U.S. FDA Center for Drug Evaluation and Research is one of the officials promoting the use of RWE. She has stated the FDA will work with stakeholders to better understand how RWE can be used to increase the efficiency of clinical research and answer questions that may not have been answered in the trials that led to the approval of a drug. RWE can also help determine how a drug works in populations that may not have been studied prior to approval.
Still, the report notes market pressures have not gone away. Almost 25 percent of respondents noted mounting pricing pressures and the need to continuously demonstrate the value of products is driving the increased focus on RWE in their organizations. Another 25 percent believe a confluence of factors is driving the heightened importance of RWE.
To gather the data for its report, Deloitte surveyed leaders from 17 pharmaceutical companies on their RWE capabilities. The surveys were conducted between January and February 2020. The entire repost can be viewed here.