Results for 'external controls'
P.S. Mishra-Kalyani, L. Amiri Kordestani, D.R. Rivera, H. Singh, A. Ibrahim, R.A. DeClaro, Y. Shen, S. Tang, R. Sridhara, P.G. Kluetz, J. Concato, R. Pazdur, J.A. Beaver
External control arms in oncology: current use and future directions
external controls, real-word data, Food and Drug Administration, FDA, external control arm
Considerations for using external controls in oncology clinical trials are complex and depend on their intended use. There is a review of recent research and marketing applications that describe the current usage of external control data in oncology. Incorporating external controls for prima…
Jan 9th • 9 mins read
Bhakti Arondekar, Mei Sheng Duh, Rachel H. Bhak, Maral DerSarkissian, Lynn Huynh, Kelsey Wang, John Wojciehowski, Melody Wu, Bryon Wornson, Alexander Niyazov, George D. Demetri
Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application
RWE, Biologics License, FDA, BLA, suplements
The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…
Jan 1st • 12 mins read