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Real-world evidence: Four shifts ushering in a new era of evidence in life sciences and health care

How serious are life sciences companies about real-world evidence (RWE)? Very, according to our new benchmark survey focused solely on the life sciences industry’s investments in RWE. More than half (54 percent) of the organizations who participated in the interviews said they are investing significantly in their RWE programs to increase their capabilities. That probably doesn’t come as news to you. With the continued shift toward value based, personalized health care — combined with the recently enacted 21st Century Cures Act, RWE is commonly becoming a strategic imperative for life sciences companies.

Real-world evidence (RWE)For many life sciences companies, real-world data (RWD), along with its downstream derivative RWE, is nothing new. What has changed is the quantity and diversity. The use of RWE has expanded beyond claims and EMR data into streaming, self-reported patient information, as well as social, genomic, and other new types of data. The use of such data across the health care ecosystem by many payers, providers, regulators, and even patients — along with external factors such as pricing pressures, safety concerns, and regulatory shifts — has helped boost volume and diversity of RWE.

In my view, based on conversations with the clients we work with every day, it seems clear that we are transitioning to the next phase of RWE applications — from RWE 1.0 to RWE 2.0. That this is happening in the midst of a broader shift to value-based care is likely no coincidence. The results of our RWE benchmarking survey indicate this transition is already underway and is accelerating.

Emerging trends in application of real-world evidence (RWE)

There are four important and consequential trends that characterize this shift that can have significant implications for life sciences innovators and manufacturers. They are:

  1. Shaping and influencing vs observing and understanding

One of the broadest trends is the shift from using RWD to a more proactive model that uses RWE insights to engage with the health care ecosystem in new ways, and to shape and influence the world in which their innovations are used. Until now, RWE was primarily used to observe and understand trends and outcomes that had already played out. RWE essentially was the electronic exhaust of the health care system. In that paradigm, for example, an epidemiologist or health economist would likely have been perfectly suited to analyze and make sense of the data procured from a vendor. A growing number of life sciences companies are now looking to use RWE not just to understand what happened, but to anticipate and shape what is likely to happen. That will likely require new operating models, external partnerships, informatics platforms, and a different type of talent altogether. Our survey findings suggest that life sciences companies are pursuing new approaches to get the talent they need. While they are recruiting heavily from other life sciences companies, they are also looking at payers, providers, and other industries.

  1. Widely available data vs insight from experts only

For most organizations, access to RWE data was previously limited to a handful of technical experts, for a number of reasons — ranging from cultural to technical. When data are licensed from vendors in highly-proprietary platforms, an expert might be needed to extract the full value. But as more modular, standards-driven, cloud-based architectures become available, access to those data (and the resulting insights) can be democratized. A wider range of life sciences users can generate value from a broader range of data, including RWE, using new analytics tools and visualization capabilities that are deployed in scalable, high-performance cloud platforms. This can enable mere mortals (as opposed to informaticians) to interact with the data to generate insights. Our survey confirms this trend toward modern platforms with 60 percent of respondents saying they use the cloud for RWE — noting benefits such as speed, stability, flexibility, and security.

  1. Data partners vs data providers

The RWE 1.0 world was commonly characterized by data vendors who sold access to data sets that were aggregated, dated, and often locked in closed platforms or proprietary formats. In the RWE 2.0 world, sources likely need to come from a network of strategic partners that enable closer connectivity with the health care system. Companies will likely need partners who are willing to collaborate with them. Data providers can then start to look more like a scientific collaborator. For an industry often accustomed to treating data providers as little more than vendors or suppliers, that’s a big shift.

As this shift occurs, the diversity and number of data partners may grow, likely requiring new systems to support enterprise use of this critical information. Centralized knowledge management and collaboration systems are likely to play a major role for stakeholders. Such systems can provide greater visibility into data sources, capture relevant metadata on each source, tap previous studies and analyses, and connect various stakeholders for better knowledge sharing. Survey respondents overwhelmingly (by more than 90 percent) say a centralized knowledge management system is a critical component of their RWE strategy.

  1. End-to-end evidence management vs product commercialization

The last big shift to RWE 2.0 can be characterized by the use of evidence from primarily market access and commercial uses, to the application of evidence across the entire value chain — from research and development (R&D) to commercial inclusive of safety, clinical operations, business development, and medical affairs. Our survey results indicate the next significant application for RWE is in R&D, particularly in the design and execution of a more targeted, personalized paradigm. From our perspective, a new end-to-end evidence management approach is essential in the RWE 2.0 world where companies think about evidence generation as a continuum rather than something that fits into siloes.

New paradigm of real-world evidence management

This transformation to the second phase of RWE couldn’t happen at a better time for the life sciences industry, or for health care in general. The life sciences world is trying to move from volume to value, and care will likely become more personalized. Life sciences companies should consider making use of the proliferation of health information (in all its forms) to contribute to better patient outcomes. Even if you already have RWE programs or capabilities in place, it is probably time to reassess where you are today — and determine where you need to be tomorrow to compete.

 

Author bio

Brett Davis is the General Manager (GM) for ConvergeHEALTH by Deloitte, part of Deloitte Consulting LLP’s innovation group (DCI). As the GM, he leads ConvergeHEALTH on its mission to support the information-based transformation of health care. In addition, Brett serves on the board of directors of the tranSMART Foundation, and the external advisory boards of both the University of Pennsylvania’s Center for Medical Ethics and Health Policy, and the Jefferson School of Population Health.