Maximizing the value of real-world evidence across the healthcare industry

For healthcare businesses, understanding real-world product and service performance is crucial for accelerating innovation, enhancing patient care and improving efficiency throughout development, authorization, commercialization, and implementation.

Real world evidence (RWE) adds value at every stage of this cycle. RWE helps companies gain deeper insights into patient experiences and health outcomes.

What is RWE?

RWE is clinical evidence derived from real-world data (RWD). This data is collected from a variety of healthcare settings, such as observational studies, randomized controlled trials, insurance claims, patient registries, wearables and electronic health records (EHRs), digital therapeutics (DTx), and billing data. 

This data is essential for health technology assessment (HTA), and regulatory and reimbursement bodies, providing a comprehensive understanding of patient care and digital health. 

RWE helps companies understand how therapies perform in diverse real-world contexts, which makes them indispensable for understanding treatment effectiveness in everyday settings.

Value of RWE in the product life cycle

RWE adds value in every stage of the product life cycle. As companies adapt to evolving market demands, seeking to enhance patient experiences and improve treatment and market access, RWE offers a clear strategic pathway. RWE complements data generated by clinical trial teams and outside of it and adds value to different stages of the asset lifecycle, from launch to adoption. It helps companies make smarter decisions, maintain market and patient access, reduce risk, and deliver more meaningful outcomes. 

Value of RWE from stakeholders' perspective

Patients, regulators, payers, and providers all use RWE to inform decisions, shape strategies and enhance outcomes. RWE can help with strategic decision-making by uncovering unmet clinical needs, price response, how treatments perform outside trial conditions, economic models and identifying existing therapies and treatments that benefit patients. Furthermore, RWE plays a critical role in informing pricing strategy consulting services, enabling healthcare organizations to develop data-backed pricing models that reflect real-world value and market dynamics. RWE can also reveal gaps in currently established pathways when it comes to care delivery and how they can be optimized. 

Tips to design RWE to support research, regulatory approval or reimbursement objective

Developing an effective RWE strategy requires more than just accessing large datasets; it involves aligning data with specific research, regulatory or reimbursement objectives. The approach requires leaders to identify the unmet needs of the stakeholders and map clear objectives that help build economic models of interest. Whether it’s for supporting regulatory submissions, improving patient outcomes or shaping market access strategies, healthcare professionals should identify new indicators and work backwards from there to determine challenges and deliver appropriate outcomes. 

For instance, if a professional is developing a connected medical device, RWE can be used to modulate the effects of the technology as experienced by patients, during clinical workflow and treatment.

Once these parameters are defined, professionals can develop a data-supported business case that allows them to redefine their models. 

An effective RWE also demands collaboration. Leaders should create an ecosystem that brings together various domains and allows professionals to invest in the right infrastructure, people, and partnerships.