Informative censoring of surrogate end-point data in phase 3 oncology trials

Informative censoring — a neglected cause of bias in oncology trials

(2020) Arnoud J. Templeton et al.   Nature Reviews Clinical Oncology

Immunotherapy With Programmed Cell Death 1 vs Programmed Cell Death Ligand 1 Inhibitors in Patients With Cancer

(2020) David Bomze et al.   JAMA Oncology

Survival-Inferred Fragility Index of Phase 3 Clinical Trials Evaluating Immune Checkpoint Inhibitors

(2020) David Bomze et al.   JAMA Network Open

Evaluation of 1-Year vs Shorter Durations of Adjuvant Trastuzumab Among Patients With Early Breast Cancer

(2020) Seema Gulia et al.   JAMA Network Open

Censored patients in Kaplan–Meier plots of cancer drugs: An empirical analysis of data sharing

(2020) Kate Rosen et al.   EUROPEAN JOURNAL OF CANCER

Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer

(2020) Thierry André et al.   NEW ENGLAND JOURNAL OF MEDICINE

Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration

(2019) Talal Hilal et al.   JAMA Oncology

Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer

(2019) Talia Golan et al.   NEW ENGLAND JOURNAL OF MEDICINE

A critique of the fragility index

(2019) David Bomze et al.   LANCET ONCOLOGY

Impact of informative censoring on the treatment effect estimate of disability worsening in multiple sclerosis clinical trials

(2019) Katherine Riester et al.   Multiple Sclerosis and Related Disorders

Hazards of Hazard Ratios — Deviations from Model Assumptions in Immunotherapy

(2018) Brian M. Alexander et al.   NEW ENGLAND JOURNAL OF MEDICINE

Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma

(2018) Joseph M. Connors et al.   NEW ENGLAND JOURNAL OF MEDICINE

OUP accepted manuscript

(2018)   JNCI-Journal of the National Cancer Institute

Brentuximab vedotin for frontline Hodgkin lymphoma: How much will a successful trial cost patients and payers?

(2018) Satish Shanbhag et al.   EUROPEAN JOURNAL OF CANCER

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

(2017) Nicholas D. James et al.   NEW ENGLAND JOURNAL OF MEDICINE

Interpretability of Cancer Clinical Trial Results Using Restricted Mean Survival Time as an Alternative to the Hazard Ratio

(2017) Kyongsun Pak et al.   JAMA Oncology

Parameterization of a disease progression simulation model for sequentially treated metastatic human epidermal growth factor receptor 2 positive breast cancer patients

(2016) Vakaramoko Diaby et al.   CURRENT MEDICAL RESEARCH AND OPINION

Influence of glioblastoma contact with the lateral ventricle on survival: a meta-analysis

(2016) Akshitkumar M. Mistry et al.   JOURNAL OF NEURO-ONCOLOGY

Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study

(2016) James C Yao et al.   LANCET

Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

(2016) Arlene Chan et al.   LANCET ONCOLOGY

Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma

(2016) Philippe Moreau et al.   NEW ENGLAND JOURNAL OF MEDICINE

Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival

(2015) Chul Kim et al.   JAMA Internal Medicine

TheRPackagesurvsimfor the Simulation of Simple and Complex Survival Data

(2015) David Moriña et al.   Journal of Statistical Software

Impact of Informative Censoring on the Kaplan-Meier Estimate of Progression-Free Survival in Phase II Clinical Trials

(2014) Federico Campigotto et al.   JOURNAL OF CLINICAL ONCOLOGY

Oral Anticancer Drugs: How Limited Dosing Options and Dose Reductions May Affect Outcomes in Comparative Trials and Efficacy in Patients

(2014) Vinay Prasad et al.   JOURNAL OF CLINICAL ONCOLOGY

The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for reporting observational studies

(2014) Erik von Elm et al.   International Journal of Surgery

Missing Data and Censoring in the Analysis of Progression-Free Survival in Oncology Clinical Trials

(2013) J. S. Denne et al.   Journal of Biopharmaceutical Statistics

Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves

(2012) Patricia Guyot et al.   BMC Medical Research Methodology

Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group

(2011) A.M. Stone et al.   EUROPEAN JOURNAL OF CANCER

Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial

(2011) Brian I Rini et al.   LANCET

The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt

(2011) Patrick Royston et al.   STATISTICS IN MEDICINE

Issues in Using Progression-Free Survival When Evaluating Oncology Products

(2009) Thomas R. Fleming et al.   JOURNAL OF CLINICAL ONCOLOGY

Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?

(2008) Lori E. Dodd et al.   JOURNAL OF CLINICAL ONCOLOGY