May 16, 2019
How Medical Imaging Data Can Accelerate Drug Development
Last December, the FDA released a preliminary framework as guidance for conducting real-world evidence (RWE) programs. According to the framework, RWE is clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD). In contrast to historical data collection methods from clinical trial settings, RWE leverages clinical, administrative, social, operational, and patient-reported outcome data captured at the time of the “patient care transaction” and not generated in a controlled setting.
With the release of this framework, many biopharmaceutical companies have started placing greater emphasis on RWE to prepare for coming regulations while driving the development of new therapies and supporting value-based contracts. The role of RWE will continue to grow in importance as organizations will be held to RWE requirements and need to demonstrate the real-world efficacy of the drugs and devices they are bringing to market.
The First Challenge of RWE
One initial hurdle with RWE is a general lack of understanding on how to best use it. Common learning curves associated with RWE include: identifying different ways to leverage RWD across the organization, determining potential biases in datasets, and optimally interpreting and utilizing the insights generated from RWD sources to support the development cycle in a reproducible way. Traditional RWD sources, such as claims and electronic medical record (EMR) data, have primarily been the foundation of RWE studies but are increasingly being challenged as being inaccurate with no linkability across other data sets of material clinical value in precision medicine trials. Though these traditional RWD sources are likely to remain important, they are insufficient to meet the specificity and sensitivity for understanding patient journeys, disease progression and treatment pathways in a way that matures the quality of evidence.