Investing in tangible capabilities such as data, technology and talent, in itself is not sufficient to capture the full potential RWE offers; pharmaceutical companies must address organizational barriers.

Much has already been written about the need for pharmaceutical companies to approach their adoption of real-world evidence (RWE) strategically and to invest in the right data, technology and talent. What is less obvious, though, is that there are less tangible factors (such as the right governance model, processes and mindset) that can determine the degree to which RWE delivers on its potential. This somewhat “softer” side of organizing around an RWE strategy is critical to creating sustained value across the product lifecycle and realizing the long-promised contribution of RWE in shaping healthcare. Here we discuss the organizational pitfalls that prevent many companies from scaling the application of RWE across the enterprise and present best practices for overcoming them.

The rise of real-world evidence (RWE) continues unabated, fueled by both supply and demand. The volume of electronic patient data has exploded, underpinned by innovation in data sources, technology and analytical methodologies. Meanwhile, healthcare stakeholders – regulators, payers, providers and patients – increasingly seek RWE to address their needs.

• Generating formal evidence to support differentiated value propositions, throughout the product lifecycle;
• Providing deeper insight to inform smarter strategies and operational decisions; and
• Enabling novel engagement models with healthcare stakeholders.

RWE can unlock substantial value for the business, for example, through accelerated market access, early regulatory approval, successful price negotiation or faster clinical trials. Indeed, our analysis has shown that by applying RWE systematically and strategically across its business, a top 10 pharmaceutical company can realize $1 billion in value.

Many pharmaceutical companies have recognized the growing importance of RWE and its potential and have been making substantial investments in building requisite capabilities, including real-world data (RWD) assets, technology infrastructure and expert talent.

However, to date, few companies have realized the full value of their RWE investments.

Investing in tangible capabilities, such as data, technology and talent, in itself is not sufficient to capture the full potential that RWE offers; it is equally important to have the critical, somewhat less tangible, organizational enablers in place. These include the right governance model, processes and mind-set. Together, these factors responsibly empower the organization, ensuring strategic alignment. They also support different ways of working, delivering enterprise-wide value and efficiencies.

Without these organizational enablers, companies struggle to effectively perform even the foundational activities necessary to create value through RWE. In our experience, pharmaceutical companies typically face the following organizational barriers:

• Unclear governance: The need for RWE spans the entire organization – cutting horizontally across functions; vertically down through the corporate headquarters, regions and affiliates; and comprehensively across franchises. A lack of clarity on responsibilities and decision rights results in duplication, increasing costs and fragmenting the RWE value chain. Evidence planning, generation and use are approached in a disjointed, ad hoc fashion by each constituency. Often these operations are not explicitly anchored in business priorities, fail to anticipate future needs and don’t take lead times into consideration in planning.
• Ownership & control mind-set: Traditionally, the pharmaceutical evidence model has been based on clinical trials and observational studies, the outputs of which drug sponsors tend to fully own and control. By contrast, RWE and the RWD it is derived from do not fit such a narrow definition of ownership. A partnership model better reflects the reality of working with RWE, as it involves securing access to third-party, real-world data sets, including from noncommercial data source owners, such as healthcare providers. The terms under which the pharmaceutical company may use the RWE must be jointly agreed upon. All too often, such a partnership mind-set is not addressed in a company’s Standard Operating Procedures (SOPs), which presents a major roadblock. At best, this causes long delays in third party negotiations and in the worst case, increases costs and damages the company’s reputation.
• Pockets of capabilities: Pharmaceutical companies that invest in RWE capabilities typically concentrate their RWE expertise; for example, in a Center of Excellence (CoE) or by having a limited number of specialists in the HEOR, Market Access or Medical functions. Conversely, the broader organization often tends to lack a fundamental understanding of RWE, including a common language for data, use cases, relevant limitations and legitimate restrictions. This prevents teams from collaborating effectively across functions and fully embracing the potential of RWE. In this environment, the value of RWE to the business is not fully delivered.
• Undue conservatism: Many companies lack an in-depth understanding of the risks associated with RWE, including data privacy, pharmacovigilance requirements and intellectual property (IP) protection. In response, they adopt a disproportionately conservative position that tightly restricts access to RWE to a few scientific users and only for very limited applications. Such a blanket position fails to consider the broader business context. Nor does it distinguish between access to real-world data vs. access to evidence and insight, or differentiate between use case-specific risks and compliance requirements. As a result, a lot of time and energy is wasted worrying about risks and over-engineering how RWE is handled. Ironically, this focus creates blind spots for managing genuine risks (e.g., the impact of the EU General Data Protection Regulation (GDPR)).
• Legacy processes: Often, companies approach RWE using SOPs that are based on the traditional requirements for formal evidence generation for scientific purposes, via Randomized Controlled Trials (RCTs). This highly restrictive approach is driven by protocols and does not reflect different functional needs or use cases, some of which may have a lower burden of proof but require greater flexibility and speed to insight. Hence they slow access and defeat the purpose of the original investment. It is not uncommon for teams to even find themselves in a situation governed by different, conflicting legacy SOPs, leading to paralysis and causing, for example, years of delays in contracting with third-party data owners. Likewise, in the absence of effective data governance and formal certification (e.g., ISO information security), companies find themselves unable to exchange RWD with third parties, making it impossible to embrace critical external partnerships or to share RWE with those healthcare stakeholders demanding it, such as regulators.

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