Results for 'clinically meaningful'
Avi Cherla, MSc; Huseyin Naci, MHS, PhD; Aaron S. Kesselheim, MD, JD, MPH; Bishal Gyawali, MD, PhD; Elias Mossialos, MD, PhD
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
Feb 22nd • 10 mins read
Vanessa Arciero, BS, Seanthel Delos Santos, Liza Koshy
Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review
Feb 11th • 4 mins read
Thakur, Sayanta & Lahiry, Sandeep
Accelerated drug approvals in oncology: Pros and cons
Sep 14th • 4 mins read
Stefanie Broes, Robbe Saesen, Denis Lacombe, Isabelle Huys
Past, Current, and Future Cancer Clinical Research Collaborations: The Case of the European Organisation for Research and Treatment of Cancer
Aug 16th • 8 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
Mateusz T. Wasylewski, Karolina Strzebonska, Magdalena Koperny, Maciej Polak, Jonathan Kimmelman, Marcin Waligora
Clinical development success rates and social value of pediatric Phase 1 trials in oncology
Jun 21st • 28 mins read
Nicole Grossmann, Martin Robausch, Eleen Rothschedl, Claudia Wild, Judit Simon
Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015
Feb 23rd • 12 mins read
Doreen A. Ezeife MD, Francois Dionne PhD, Aline Fusco Fares MD, Ellen Laura Rose Cusano MD, Rouhi Fazelzad BSc, MISt, Wenzie Ng BSc, MPharm, RPh, Don Husereau BSc Pharm, MSc, Farzad Ali BPharm, MSc, Christina Sit MSc, Barry Stein B.Com BCL, LLB, Jennifer
Value assessment of oncology drugs using a weighted criterion-based approach
Dec 20th • 15 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
Anushka Walia, Alyson Haslam, Vinay Prasad
FDA validation of surrogate endpoints in oncology: 2005–2022
Dec 1st • 20 mins read
S.F. Oosting, J. Barriuso, A. Bottomley, M. Galotti, B. Gyawali, B. Kiesewetter, N.J. Latino, F. Martinelli, M. Pe, G. Pentheroudakis, F. Roitberg, H. Vachon, E.G.E. de Vries, M. Piccart, N.I. Cherny
Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale
Apr 1st • 30 mins read
Envision Pharma Group
Patient involvement: A must-have in medicine development, but is it being overlooked in a cost-constrained environment?
May 9th • 5 mins read
Envision Pharma Group
Empowering people to drive medical affairs performance with AI
Aug 14th • 5 mins read
Neil Carleton and Priscilla F. McAuliffe
Are the chronological age cutoffs used in clinical oncology guidelines biologically meaningful?
Dec 1st • 4 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
Dominic H. Moon, Ronald C. Chen
Defining a Clinically Meaningful Benefit in Cancer Clinical Trials: From the Perspectives of the Clinical Trialist, Patient, and Society
Jun 27th • 2 mins read
Emerson Y. Chen, MD, Sunil K. Joshi, BA, Audrey Tran, BA
Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials
Apr 1st • 10 mins read
Envision Pharma Group
AI-powered real-world evidence: Strategically enhancing value and access
Aug 22nd • 5 mins read
