“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.”
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September 22, 2022 at 08:26PM
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