Deloitte’s recent survey reflects the increasing role of real-world evidence

Deloitte’s real-world evidence (RWE) benchmarking survey studies how biopharma companies are using RWE, what they are investing in, areas of impact, and the hurdles to successful adoption.

Many biopharma companies are increasingly using real-world evidence (RWE) – clinical evidence about a product’s usage, potential benefits, and risks derived from real-world data (RWD) – not only to demonstrate the value of their products but increasingly to address regulatory requirements, drive drug development, support outcomes-based contracts, and reduce products’ time to market.

This year’s survey shows that biopharma companies are investing more in RWE capabilities, with a focus on end-to-end solutions that address the entire product life cycle. In the survey, 90 percent of respondents have either already established or are currently investing in building RWE capabilities for use across the entire product life cycle, though only 45 percent currently have capabilities mature enough to do so.

According to respondents, stakeholder pressure to demonstrate the value of treatments and a shift toward personalized care, as well as new business imperatives such as value-based contracting, novel clinical trial design and execution, and support for regulatory submission, are helping drive this effort.

Though biopharma companies have traditionally relied on external vendors for RWD collection and analysis, many are now opting to develop these RWE capabilities in-house: 70 percent of respondents are building or increasing capabilities to conduct more of their RWE studies internally, and 15 percent are building capabilities to exclusively resource studies internally.

The two biggest increases in investment over the next year are expected to be in people (30 percent) and technology platforms (25 percent) to support the organization’s RWE capability. Hiring experts to build and implement RWE-enabling systems, such as machine learning systems, may be the prime and immediate focus. But it is also important to make RWD and analytics accessible to a wide range of internal stakeholders, calling for investment in the right technology platforms and external partnerships to democratize the uses and insights that RWD promises.

Like other industries, some biopharma companies are overhauling their IT platforms and strategies to support the big data analytics that are central to RWD analysis and insight. The trend appears to be toward a centralized, largely cloud-based enterprise platform that is capable of data ingestion and integration, advanced analytics, visualization, and knowledge management.

And as the volume, variety, and velocity of structured and unstructured real-world data grow, artificial intelligence and machine learning will likely be required to adequately capitalize on the potential of health care data to generate life-saving insights such as identifying patients with undiagnosed or underdiagnosed diseases. In our survey, only 60 percent of respondents report currently using machine learning, but almost all—95 percent—expect to use it for RWE in coming years.

Another interesting trend is the increasing use of nontraditional RWD such as purpose-built linked data (such as clinical data linked to molecular data) and data generated from patients’ wearables or health apps to generate RWE. Evidence generated from these sources could provide quicker and deeper insights into disease progression, treatment pathways, and patient benefit. This trend can also create new opportunities for partnerships with health systems, patient advocacy groups, digital health start-ups, and even patients themselves over time. While less than 60 percent of companies are currently using these data sources, several expect to increase their use in the next 12–18 months.

Visible buy-in and support from executive-level leadership is necessary to change the company’s mindset and drive broader adoption of real-world data use across the enterprise, while lack of receptivity from external stakeholders can be overcome through transparent communication and new collaborative models for engagement. Strategic partnerships can also be important for the integrated adoption of RWE, especially when it comes to data access.

As the importance of RWE continues to rise, the answers for biopharma companies seem to lie in enterprisewide technology solutions, new operating models to support end-to-end evidence management, and external partnerships.

Deloitte is one of the “Big Four” accounting organizations and the largest professional services network in the world by revenue and number of professionals. Deloitte provides audit, tax, consulting, enterprise risk and financial advisory services with more than 263,900 professionals globally.