Design of non-inferiority randomized trials using the difference in restricted mean survival times

Commentary

(2017) Charles Poole   EPIDEMIOLOGY

Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review

(2017) Turki A. Althunian et al.   Trials

Demonstrating Noninferiority of Accelerated Radiotherapy With Panitumumab vs Standard Radiotherapy With Cisplatin in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma

(2017) David Cheng et al.   JAMA Oncology

Restricted Mean Survival Time as a Measure to Interpret Clinical Trial Results

(2017) Dae Hyun Kim et al.   JAMA Cardiology

Noninferiority is almost certain with lenient noninferiority margins

(2016) Maria Elena Flacco et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Noninferiority is (too) common in noninferiority trials

(2016) Darius Soonawala et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Restricted Mean Survival Time: An Obligatory End Point for Time-to-Event Analysis in Cancer Trials?

(2016) Roger P. A’Hern   JOURNAL OF CLINICAL ONCOLOGY

Comparison of Treatment Effects Measured by the Hazard Ratio and by the Ratio of Restricted Mean Survival Times in Oncology Randomized Controlled Trials

(2016) Ludovic Trinquart et al.   JOURNAL OF CLINICAL ONCOLOGY

Non-inferiority trials: are they inferior? A systematic review of reporting in major medical journals

(2016) Sunita Rehal et al.   BMJ Open

Alternatives to Hazard Ratios for Comparing the Efficacy or Safety of Therapies in Noninferiority Studies

(2015) Hajime Uno et al.   ANNALS OF INTERNAL MEDICINE

Reporting of Noninferiority Trials in ClinicalTrials.gov and Corresponding Publications

(2015) Anand D. Gopal et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor

(2015) Maria Elena Flacco et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting

(2015) Olaf M. Dekkers et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

The choice of the noninferiority margin in clinical trials was driven by baseline risk, type of primary outcome, and benefits of new treatment

(2015) Angèle Gayet-Ageron et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Non-inferiority trials: why oncologists must remain wary

(2015) Mauricio Burotto et al.   LANCET ONCOLOGY

Moving Beyond the Hazard Ratio in Quantifying the Between-Group Difference in Survival Analysis

(2014) Hajime Uno et al.   JOURNAL OF CLINICAL ONCOLOGY

Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome

(2013) Patrick Royston et al.   BMC Medical Research Methodology

Reporting of Noninferiority and Equivalence Randomized Trials

(2013) Gilda Piaggio et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

(2013) A.-W. Chan et al.   BMJ-British Medical Journal

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

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

The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants

(2012) G. Wangge et al.   CANADIAN MEDICAL ASSOCIATION JOURNAL

How to Use a Noninferiority Trial

(2012) Sohail M. Mulla et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

(2012) Petra Schiller et al.   Trials

The ClinicalTrials.gov Results Database — Update and Key Issues

(2011) Deborah A. Zarin et al.   NEW ENGLAND JOURNAL OF MEDICINE

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

Through the looking glass: understanding non-inferiority

(2011) Jennifer Schumi et al.   Trials

Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers

(2010) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY

On the Origin of Risk Relativism

(2009) Charles Poole   EPIDEMIOLOGY

The Hazards of Hazard Ratios

(2009) Miguel A. Hernán   EPIDEMIOLOGY

Sample size estimation for non-inferiority trials of time-to-event data

(2007) Adam Crisp et al.   PHARMACEUTICAL STATISTICS