Focus on Use of RWE Shifting to R&D, Companies With Mature Capabilities Realizing Enterprise Value, Deloitte Survey Finds

• Deloitte third Real-World Evidence (RWE) benchmarking survey shows, a stratification of results from companies that have invested in more mature RWE capabilities from those that have less mature organizational and technical capabilities.
• Ninety-four percent of survey respondents believe using RWE in R&D will become important or very important to their organizations by 2022.
• Survey respondents expect a shift in the application of RWE in the next two to three years with the highest impact being in R&D, including supporting regulatory filings and augmenting clinical trials, in contrast to the more traditional applications where they realize value today.
• Organizations reporting to have mature RWE capabilities were more likely to have reduced clinical trial costs and trial failure rates through the use of RWE in R&D.
• Seventy percent say that a lack of research-grade data is hindering RWE efforts in R&D. This emphasizes the importance of establishing strategic partnerships: More than 80% of surveyed companies are entering into strategic partnerships to access new sources of RWD.

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Why this matters

The pressure to leverage RWE to accelerate drug development and enable market access has not dissipated since Deloitte previous RWE survey in 2018. It is likely more critical in wake of COVID-19, as it presents several opportunities to inform recovery strategies to mitigate the impact of the pandemic on planned or ongoing studies. Mounting pricing pressures, coupled with declining returns on R&D, are pushing companies to find new ways to leverage RWE across the product life cycle. With regulators continuing to signal openness to RWE, and payers demanding more evidence to support the value of products, developing enterprise-wide RWE capabilities has become mission critical to the pharmaceutical industry.

What companies with mature RWE capabilities are doing

Deloitte survey data shows that companies with mature RWE capabilities — defined as those companies with robust capabilities already in place to leverage RWE across the entire product lifecycle — are more likely to realize the value in the use of RWE in R&D; enter into strategic partnerships to access RWD; and have already implemented centralized knowledge management and analytics platforms.

Most survey respondents (70%) regardless of maturity — believe RWE will become very important to their C-suite by 2022. Interestingly, companies that reported that they have a mature RWE capability in place (almost half of survey participants) said RWE had already reached the highest level of importance to their C-suite today.

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The importance of RWE continues to grow in R&D

There are several areas where RWE can be applied in R&D. Using RWE can inform better protocol design, thereby reducing the number of costly protocol amendments, and can enable the creation of synthetic control arms to accelerate trial execution and decrease overall cost. Similarly, RWE can accelerate label expansion and decreases the overall cost of the evidence needed for filing. This year’s survey assessed the level of importance of RWE in R&D, biggest areas of opportunity, early successes, and challenges to seeing impact.

• Survey respondents expect the importance and use of RWE in R&D to increase significantly in the next two years.
• More than 40% of this year’s respondents say recent FDA guidance and statements encouraging RWE use in R&D are driving an increased strategic focus. Others pointed to mounting pricing and market access pressures, the rising cost of development, or a combination of these factors
• Almost all survey respondents (96%) expect RWE to have a greater impact on R&D in oncology as compared to other therapy areas.

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