Results for 'time-to-event endpoints'
Shubham Sharma, J Connor Wells, Wilma M Hopman, Joseph C Del Paggio, Bishal Gyawali, Nazik Hammad, Annette E Hay, Christopher M Booth
Cancer, Clinical Trials, and Canada: Our Contribution to Worldwide Randomized Controlled Trials
Apr 13th • 10 mins read
Consolación Molto MD, Thomas J. Hwang AB, Maria Borrell MD, Marta Andres MD, Ignasi Gich MD, PhD, Agustí Barnadas MD, PhD, Eitan Amir MD, PhD, Aaron S. Kesselheim MD, JD, MPH, Ariadna Tibau MD, PhD
Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration
Jul 22nd • 12 mins read
Barbara Kiesewetter , Nathan I Cherny, Nicolas Boissel, Francesco Cerisoli, Urania Dafni, Elisabeth G E de Vries, Paolo Ghia, Nicola Gökbuget, Verónica González-Calle, Brian Huntly, Ulrich Jäger, Nicola Jane Latino, Jean-Yves Douillard, Luca Malcovati, Ma
EHA evaluation of the ESMO-Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for hematological malignancies
Jan 20th • 20 mins read
Idine Mousavi, BA; Timothée Olivier, MD; Vinay Prasad, MD, MPH
Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022
Jun 10th • 30 mins read
Roman Adam, Ariadna Tibau, Consolación Molto Valiente, Boštjan Šeruga, Alberto Ocaña, Eitan Amir, Arnoud J. Templeton
Clinical benefit of cancer drugs approved in Switzerland 2010–2019
Jun 10th • 35 mins read
Christopher A. Busch, MSC; Johannes Krisam, PhD; Meinhard Kieser, PhD
A Comprehensive Comparison of Additional Benefit Assessment Methods Applied by Institute for Quality and Efficiency in Health Care and European Society for Medical Oncology for Time-to-Event Endpoints After Significant Phase III Trials—A Simulation Study
Jun 28th • 30 mins read
Yichen Zhang, MSc; Huseyin Naci, PhD; Anita K. Wagner, PharmD, DrPH
Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020
Aug 10th • 30 mins read
Rachel E. Sachs, JD, MPH, Kyle A. Gavulic, BA, Julie M. Donohue, PhD
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
Oct 8th • 25 mins read
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
Dec 1st • 20 mins read
Consolacion Molto, Ariadna Tibau, Aida Bujosa, Jose Carlos Tapia, Abhenil Mittal, Faris Tamimi & Eitan Amir
Association between control group therapy and magnitude of clinical benefit of cancer drugs
Dec 9th • 20 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Report from American Society of Clinical Oncology Symposium 2020 and American Society of Clinical Oncology Gastrointestinal Cancer Symposium 2021
Aug 4th • 13 mins read
Bishal Gyawali, Benjamin N Rome, Aaron S Kesselheim
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study
Aug 4th • 12 mins read
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
Apr 30th • 12 mins read
MAXIMILIAN SALCHER-KONRAD, HUSEYIN NACI, COURTNEY DAVIS
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
Oct 6th • 48 mins read
Jiaxi Zhou, Jonathon Vallejo, Paul Kluetz, Richard Pazdur, Tamy Kim, Patricia Keegan, Ann Farrell, Julia A Beaver, Rajeshwari Sridhara
Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016
Aug 4th • 15 mins read
Ariadna Tibau, Consolación Molto, Alberto Ocana, Arnoud J Templeton, Luis P Del Carpio, Joseph C Del Paggio, Agustí Barnadas, Christopher M Booth, Eitan Amir
Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
Dec 13th • 7 mins read