What is Real-world evidence?

Real-world evidence (RWE) is observational evidence that is generated in routine clinical practice. 

RWE is generated by analyzing real-world data (RWD), which can come from a variety of sources (collected retrospectively or prospectively). It can be generated from several types of trial and study design, including observational studies, surveys, and pragmatic trials, and from a variety of sources, such as: 

• electronic health records 
• patient-generated data (including data gathered in home and community settings) 
• insurance claims 
• disease and product registries 
• surveys 
• data gathered from mobile devices that can indicate the health status of patients. 

How is real-world evidence used by biopharma manufactures? 

In modern clinical research, data are key to the successful development and access of new pharmaceutical and biotechnology products and can help expedite the availability of effective treatments. Manufacturers that develop novel targeted therapies, especially in the rare disease space, can face challenges with funding and approval where data are perceived to be lacking. 

Manufacturers can use RWE strategies to better leverage data on the effectiveness and safety of novel therapies over time, and develop iterative evidence generation strategies to meet payer requirements. 

Maximize the value of your asset by leveraging real-world evidence 

Global regulatory authorities, including the US Food and Drug Administration, are increasingly taking note of the importance of RWD and RWE. 

In this free article, we explore this important trend and explain: 

• how manufacturers can leverage RWE to highlight the value of high-cost and low-volume therapies and highly targeted novel therapeutic approaches such as CAR-Ts 
• why engagement with healthcare professionals is crucial for generating RWE and some recommendations for effective partnerships. 

Helping you gather and leverage real-world evidence 

PRMA Consulting is a member of Fishawack Health, and together we are uniquely placed to help you leverage RWE for your products, bringing them to market, and highlighting the importance of RWE for stakeholders.  

Please get in touch for confidential conversation about your RWE needs.