Real world evidence (RWE) is a cornerstone for informed decision-making, and leaders who can efficiently leverage this data to achieve desired outcomes can create value and long-term success in the industry.
Real world evidence and its insights into efficacy, patient outcomes and market potential of a product are major determiners for pharma to create value. But long-term success comes with understanding RWE and how to manage it strategically.
Decision-makers have always relied on data insights derived from controlled settings of clinical trials. However, most time, these insights fail to demonstrate the potential outcome and risk of the products and therapy in real-world or routine care settings. Additionally, these insights may not always offer guidance about patients with rare diseases and different genetic structures.
RWE has the potential to enhance product development. RWE is the evidence or health insights collected outside of traditional Randomized Controlled Trials (RCT). This may include information from electronic medical records, billing, patient- and clinician-reported outcomes measures, patient surveys, wearables, medical devices and other healthtech solutions.
Data extracted from RWE enable leaders to observe product effectiveness and treatment impact across diverse patient populations. This data can be qualitative and unstructured but helps provide significant insights to regulatory and Health Technology Assessment (HTA) personnel as it provides an overall view of patient care.
Role in the product life cycle
RWE complements data generated by clinical trial teams and added value to various stages of the asset lifecycle, from launch to adoption. From the get-go, RWE can identify unmet patient needs and disease progression and optimize study designs that provide practical solutions. Later, RWE can help predict market demand, how drugs may behave in different settings, on different genetic structures and identify patients who may benefit from the product. These insights can be extremely beneficial in identifying patterns that may have not been apparent in RCT.
To date, RWE has been most effective in designing post-marketing strategies and monitoring success.
Value from the stakeholder’s perspective
RWE can help with strategic decision-making by uncovering unmet clinical needs, price response and identifying existing therapies and treatments that are benefiting patient outcomes. At the same time, it can reveal gaps in currently established pathways when it comes to care delivery and how they can be optimized for better patient outcomes. Payers and stakeholders can use RWE to understand marginal clinical value and make informed decisions based on the available data.
How can leaders design and leverage RWE?
As the industry moves towards data-driven decisions, leaders must identify how they can design RWE studies to support research and regulatory approval.
Start by assessing the landscape
Before diving right into study design, leaders should define objectives and identify where the needs are unmet. This may involve understanding the effectiveness of treatment, identifying new indicators for a drug, and working backwards from there to determine challenges and deliver appropriate outcomes.
Refine economic models and pricing strategies
RWE insights can help redefine price structure and identify how the targeted customer will perceive them. Through a granular pricing analysis, leaders can build a data-supported business case and justify the product cost to payers and stakeholders.
The long-term success of a product is highly dependent on how leaders use RWE to their advantage. They can position the product for success through the right resources and collaborate with vendors and industry experts to derive services through RWE.
