Duration of and time to response in oncology clinical trials from the perspective of the estimand framework

Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development

(2023) Stefan Englert et al.   PHARMACEUTICAL STATISTICS

KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study

(2021) Bijal D Shah et al.   LANCET

Sotorasib for Lung Cancers with KRAS p.G12C Mutation

(2021) Ferdinandos Skoulidis et al.   NEW ENGLAND JOURNAL OF MEDICINE

Comparison of Duration of Response vs Conventional Response Rates and Progression-Free Survival as Efficacy End Points in Simulated Immuno-oncology Clinical Trials

(2021) Chen Hu et al.   JAMA Network Open

What matters most? Different stakeholder perspectives on estimands for an invented case study in COPD

(2020) Oliver N. Keene et al.   PHARMACEUTICAL STATISTICS

Analysis of Response Data for Assessing Treatment Effects in Comparative Clinical Studies

(2020) Bo Huang et al.   ANNALS OF INTERNAL MEDICINE

Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC

(2020) Roy S. Herbst et al.   NEW ENGLAND JOURNAL OF MEDICINE

Appropriate Analysis of Duration of Response Data in Cancer Trials

(2020) Zachary R. McCaw et al.   JAMA Oncology

Local Investigators Significantly Overestimate Overall Response Rates Compared to Blinded Independent Central Reviews in Phase 2 Oncology Trials

(2020) Cinzia Dello Russo et al.   JOURNAL OF CLINICAL PHARMACOLOGY

A multistate model for early decision‐making in oncology

(2019) Ulrich Beyer et al.   BIOMETRICAL JOURNAL

Impact of Time Between Induction Chemotherapy and Complete Remission on Survival Outcomes in Patients With Acute Myeloid Leukemia

(2019) Rafiye Ciftciler et al.   Clinical Lymphoma Myeloma & Leukemia

Treatment effect quantification for time-to-event endpoints-Estimands, analysis strategies, and beyond

(2018) Kaspar Rufibach   PHARMACEUTICAL STATISTICS

iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

(2017) Lesley Seymour et al.   LANCET ONCOLOGY

Patient Versus Physician Valuation of Durable Survival Gains: Implications for Value Framework Assessments

(2017) Jason Shafrin et al.   VALUE IN HEALTH

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

(2016) John F R Robertson et al.   LANCET

Estimands in clinical trials - broadening the perspective

(2016) Mouna Akacha et al.   STATISTICS IN MEDICINE

Pseudoprogression and Immune-Related Response in Solid Tumors

(2015) Victoria L. Chiou et al.   JOURNAL OF CLINICAL ONCOLOGY

New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)

(2008) E.A. Eisenhauer et al.   EUROPEAN JOURNAL OF CANCER