VP, Global Evidence, BioPharmaceuticals Medical, AstraZeneca; Editorial Board Member at Pharmaceutical Medicine Journal
Exactly! "...although real-world evidence has often been thought of as inferior, it has the potential to greatly inform gold-standard clinical trial evidence in ways that make clinical trials more thorough and representative of the patients they intend to serve. Furthermore, real-world evidence can often accelerate the clinical trial process, potentially bringing new therapies to patients earlier. Finally, the large datasets commonly associated with real-world data investigations render more likely the possibility of unanticipated novel observations and analyses that may not be possible with information from clinical trials alone..." https://lnkd.in/e7WCpU7X #realworlddata #realworldevidence #rwe #rwd #data #healthcare #biopharma #medicalaffairs
I totally agree with you. RWE definitely complement RCT evidence. It is even more useful for rare diseases. However, one should understand the analytical models as well to better understand and account for biases in the evidence base. 3- level Hierarchical models are useful in incorporating both RCT and RWE by individual modelling of study designs and incorporating the variance either as common variance or randmly from a larger sample.
Love this. And the novel sources of real world data to inform the evidence is advancing all the time.
JIHEN TOUMI
2w
Definitely, we should be embracing innovation in data generation. The new healthcare landscape is starting to shape the types of evidence generation required both from a regulatory perspective and in response to increasing stakeholder sophistication with evidence. Some experts, even, anticipate, over the medium term (next three to five years) an increased FDA receptiveness to RWE and acceptance of this data beyond label expansion and safety purposes
Agree! To me, real-world evidence is the clinical trial confirmation, mostly because the clinical outcomes obtained with the strict patient selection in the latest, needs to be confirmated with “real” patients. Thanks for sharing!
Great research turns into great practice!
I couldn’t agree more !
Jennifer L.
2w
Reading this couldn’t have come at a better time. Thank you!
Thank you for bringing up this topic!
100% ✅
Vice President, Marketing at Verantos
2wAnd not just for ophthalmology or oncology! With sufficiently high-quality RWD, and proper study design, it should be possible to extend the successes seen mostly in oncology to other TAs. The challenge is that the typical claims or even “claims plus EHR” dataset used outside onc doesn’t really cut it.