The terms Real World Evidence (RWE) and Real World Data (RWD) appear more and more in industry discussions and within FDA reports. The pharma industry is embracing RWE and it is quickly becoming the next big thing in industry intelligence. FDA guidelines have been published for using RWE in clinical studies and the FDA is moving towards how it can best use RWE to improve regulatory decision making. Without a doubt, stakeholders in the healthcare landscape – healthcare providers, payers, regulators, pharmaceutical companies, and most of all patients – can all benefit from the use of RWE, which continues to drive interest.

By definition, RWE is any insights generated by Real World Data. RWD uses massive patient level datasets to determine interventions’ effectiveness in real-world circumstances.

Understanding how one drives the other and how to best use and interpret these valuable tools form the basis of these two KMK’s white paper. Hypothetical case studies and challenges and solutions are explored demonstrating the proper usage of these important tools in the life sciences.

Developed by the KMK HEOR team, these white papers demonstrate the team’s expertise in real-world evidence studies, which enables us to choose optimal data sources and to conduct sophisticated analysis to overcome data limitations. We show the need for meticulous methodologies in balancing selection bias and data quality issues in the design of a study, as well as how to best conduct the analytical process.

Turning Real World Data Into Real World Evidence
The Pitfalls to Avoid to Best Aid Decision Making

Real World Evidence
Where and How It is Best Used