Mission critical. Biopharma companies are accelerating real-world evidence adoption, investment, and application

Print 02 July 2018
Deloitte Insight

What is real-world data (RWD) and real-world evidence (RWE)? Real-world data refers to health care data gathered from a variety of sources, outside of randomized controlled clinical trials. These data sources can include electronic medical records (EMRs), health insurance claims, genomic data, and data from health apps, wearables, and other biometric devices. Real-world evidence refers to the insights that are generated from these data.

The Food and Drug Administration (FDA) refers to RWE as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD.”1 For a detailed discussion about what RWE is, what it does, and how it helps biopharma companies develop products safely and effectively, refer to our inaugural RWE benchmark survey from 2017, Getting real with real-world evidence.

Since the publication of our first survey in Spring 2017, regulators have advanced RWE initiatives (see sidebar, “The advancing regulatory science of RWE”), and some companies have been aggressive in their strategy to access RWD and generate RWE. For instance, in February 2018, Roche announced the acquisition of Flatiron Health, a health care technology company with a large oncology-EMR system, for US$2 billion. Roche cited the possibility of harnessing the EMR data for research purposes— potentially speeding up and improving drug development—as a key driver of the decision.

For this year’s survey, we sought to understand more about what’s inspiring companies to take such bold steps to access and use RWD and what investments they are making in this area (for more detail on this year’s survey see the sidebar, “Survey methodology”). Our survey results reveal that:

• RWE is being used to achieve key strategic priorities across the product life cycle.

• Companies are investing in people, data, and technology (including machine learning) to build internal capabilities.

• Increasing use of nontraditional data sources will likely require external strategic partnerships.

• Internal and external barriers threaten the success of RWE initiatives.

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