“RWE is meant to demonstrate the challenges and outcomes of treating and managing patients in the real world,” Matthew Gordon, Vice President of real-world evidence strategy at Parexel told us. According to him, the patient insight gathered in an RWE trial offers the clinical research organization (CRO) an opportunity to understand the patient’s perspective.
RWE data and patient centricity are two major components of Parexel's strategy. “Both pharmaceutical companies and CROs recognize that some of the traditional ways of conducting research are burdensome, costly, and time intensive,” explained Gordon.
“RWE studies can support identification of patient populations and outcomes of interest to optimize the development of a protocol or to identify outcomes of interest. In select cases, we are seeing RWE research used as an external control arm for trials that are difficult to identify or recruit patients, or for trials where there simply aren’t enough patients to conduct a randomized control trial,” said Gordon.
In clinical trials pertaining to treatments for orphan or rare diseases which typically have smaller patient populations, RWE can shorten the timeline to get treatments into patient’s hands by using RWE to identify patients.
Additionally, RWE can create external control arms. External control arms can enable patients to receive investigative treatment rather than placebo and decrease the number of participants needed to conduct the study.
Gordon stated, “while RWE has been used to understand the post-approval safety and effectiveness of a product it’s use has now been expanded to earlier in the development lifecycle.”
He explains that given that data from clinical trials cannot be generalized to the larger population but RWE studies can complement clinical trials by providing a understanding of the patient population.
As the CRO focuses on developing patient-centered design for RWE studies considerations have to be made particularly when it comes to patient data and privacy. “It is important to understand the context in which the data has been collected and to apply appropriate data analytics methodologies for the questions of interest,” explained Gordon.
He added, “Transparency is a critical component, from data acquisition to analysis and publication. In addition, data privacy is critically important to ensure patients are protected.” Parexel, Gordon told us, is using data linking strategies to help ensure data privacy while not compromising potential applications.