Results for 'external controls'
Robbe Saesen, Georgios Kantidakis, Ann Marinus, Denis Lacombe, Isabelle Huys
How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer
Aug 1st • 45 mins read
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
Dec 1st • 20 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
Apr 6th • 2 mins read
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
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
Jan 1st • 12 mins read
Aviv Ladanie, PhD, Andreas M. Schmitt, MD, Benjamin Speich, PhD, Florian Naudet, PhD, Arnav Agarwal, MD, Tiago V. Pereira, PhD, Francesco Sclafani, PhD, Amanda K. Herbrand, MD, Matthias Briel, MD, MSc, Juan Martin-Liberal, PhD, Thomas Schmid, MD, Hannah E
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016
Nov 10th • 6 mins read
