In a recent discussion, Syapse’s Thomas Brown and Alissa Winzeler-Cotton, along with Pfizer’s Manuela Di Fusco and Orazio Caffo of Santa Chiara Hospital in Trento, Italy, shared their insights regarding real world data (RWD) and real world evidence (RWE). They note that RWD offers immense insight into a drug’s efficacy, can impact the FDA’s decision-making, and overcome the constraints of traditional clinical trials. However, useful results require high quality data sources, which can constitute a significant challenge.
Dr. Orazio Caffo remarks, “The different approaches to collection and analysis can generate real-world data and evidence that are rarely fully comparable and combinable. To help address this, the native real-world data should be made available for further elaborations and analyses, to overcome limitations due to differences in collection modalities etc. Clearly, the available infrastructure at the level of a single center is not sufficient to guarantee data sharing of isolated sets. Big data analysis could overcome this limitation.” Read more here.
(Source: The Evidence Base, 5/19/21)