Good Enough: A Primer on the Analysis and Interpretation of Noninferiority Trials

No abstract is available for this paper.

• Publication year

  2006

• Venue

  Annals of Internal Medicine

• Publication date

  2006-07-04

• Fields of study

  Medicine

• Identifiers
  DOI 10.7326/0003-4819-145-1-200607040-00011PMID 16818930
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Lessons from and cautions about noninferiority and equivalence randomized trials.

  2006cited by this paper
• Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.

  2006cited by this paper
• Quality of reporting of noninferiority and equivalence randomized trials.

  2006cited by this paper
• Trials and tribulations of noninferiority: the ximelagatran experience.

  2006cited by this paper
• Trials and tribulations of non-inferiority: the ximelagatran experience.

  2005influential reference
• Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial.

  2005influential reference
• A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non‐inferiority Trials

  2005cited by this paper
• Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.

  2004cited by this paper
• Design and analysis of non‐inferiority mortality trials in oncology

  2004cited by this paper
• Prior convictions: Bayesian approaches to the analysis and interpretation of clinical megatrials.

  2004cited by this paper
• Safety and efficacy of enoxaparin vs unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes who receive tirofiban and aspirin: a randomized controlled trial.

  2004cited by this paper
• Enoxaparin vs. unfractionated heparin in high-risk patients with non-ST-Segment elevation acute coronary syndromes managed with an intended early invasive strategy—primary results of the SYNERGY randomized trial☆

  2004cited by this paper
• Alternatives for Discounting in the Analysis of Noninferiority Trials

  2004cited by this paper
• Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both.

  2003influential reference
• Comparative efficacy of thrombolytics in acute myocardial infarction: a systematic review.

  2003cited by this paper
• Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial.

  2003influential reference
• Policy developments in regulatory approval

  2002cited by this paper
• Design and analysis of non‐inferiority mortality trials in oncology

  2002cited by this paper
• Some fundamental issues with non‐inferiority testing in active controlled trials

  2002cited by this paper
• Non‐inferiority trials: design concepts and issues – the encounters of academic consultants in statistics

  2002cited by this paper
• Statistical Methods for Comparison to Placebo in Active-Control Trials

  2001cited by this paper
• Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization.

  2001cited by this paper
• Equivalence and noninferiority trials.

  2000cited by this paper
• Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues

  2000cited by this paper
• Claims of Equivalence in Medical Research: Are They Supported by the Evidence?

  2000cited by this paper
• Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases

  2000cited by this paper
• Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained.

  1999cited by this paper
• Bayesian Design and Analysis of Active Control Clinical Trials

  1999cited by this paper
• A Comparison of Continuous Infusion of Alteplase with Double-Bolus Administration for Acute Myocardial Infarction

  1998cited by this paper
• A comparison of reteplase with alteplase for acute myocardial infarction.

  1998cited by this paper
• Equivalence trials.

  1997cited by this paper
• A comparison of continuous infusion of alteplase with double bolus administration for acute myocardial infarction: the continuous infusion versus double double bolus administration of alteplase

  1997cited by this paper
• A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction.

  1997cited by this paper
• Proving the Null Hypothesis

  1992cited by this paper
• Annals of Internal Medicine

  1992cited by this paper
• Proving the null hypothesis.

  1991cited by this paper
• Common Sense, The Rights of Man, and Other Essential Writings of Thomas Paine

  1984cited by this paper
• "Proving the null hypothesis" in clinical trials.

  1981cited by this paper

• Is There Benefit in Using an Adductor Canal Catheter in Knee Arthroplasty? A Randomized Clinical Trial.

  2025cites this paper
• Extended Treatment with Reduced-Dose Direct Oral Anticoagulants for Venous Thromboembolism: Systematic Review and Bayesian Non-Inferiority Reanalysis.

  2025cites this paper
• Intrathecal bupivacaine versus bupivacaine plus fentanyl for anaesthesia for Caesarean delivery: a randomised double-blind noninferiority trial.

  2025cites this paper
• Effect of a single prostaglandin F2α presynchrony 3 to 4 days prior to treatment of anestrous dairy cows with a novel intravaginal progesterone-releasing device and Ovsynch.

  2025cites this paper
• Consensus position statement on advancing the classification of patients and tests of cure in studies of antibiotic treatment of complicated urinary tract infections.

  2025cites this paper
• Automated Modes to Improve Mechanical Ventilation Outcomes-The Ghost in the Machine.

  2025cites this paper
• Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial

  2024cites this paper
• The impact of a medically directed student registered nurse anesthesia staffing model on Postprocedural patient outcomes.

  2024cites this paper
• Propofol sedation does not improve measures of colonoscopy quality but increase cost – findings from a large population-based cohort study

  2024cites this paper
• Non-inferiority Study Design: Application to Clinical Trials.

  2024cites this paper
• Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-Student Emerging Adults: Study Protocol for Project BLUE, a Randomized Controlled Trial

  2024cites this paper
• The null need not be nil: Clarifying the parallel arbitrariness of difference testing and equivalence testing.

  2024cites this paper
• Effectiveness of a nonweight‐based daily dosage of ready‐to‐use therapeutic food in children suffering from uncomplicated severe acute malnutrition: A nonrandomized, noninferiority analysis of programme data in Afghanistan

  2024cites this paper
• A Comparison of Telehealth and In-Person Therapy for Youth Anxiety Disorders

  2024cites this paper
• Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression.

  2023cites this paper
• Ensuring Superior Reporting of Radiation Therapy Noninferiority Trials: A Systematic Review

  2023cites this paper
• Islamic trauma healing (ITH): A scalable, community-based program for trauma: Cluster randomized control trial design and method

  2023cites this paper
• TNF-? inhibitors and post-operative surgical site infections in rheumatoid arthritis

  2023cites this paper
• Protocol for a Randomized Control Trial for Tungiasis Treatment in Homa Bay County, Kenya: Dimeticone versus Sodium Carbonate

  2023cites this paper
• Lecture critique d’articles

  2023cites this paper
• Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance

  2023cites this paper
• Design of a clinical trial using generalized pairwise comparisons to test a less intensive treatment regimen

  2023cites this paper
• Real-World Evidence for Causal Inference-Are We Ready?

  2023cites this paper
• Perceived acceptable uncertainty regarding comparability of endovascular treatment alone versus intravenous thrombolysis plus endovascular treatment

  2022cites this paper
• A quantitative risk metric to support individual sanitary measure reviews in international trade.

  2022cites this paper
• Multistakeholder social media peer review and fixing slips

  2022cites this paper
• Risk difference, relative risk, and odds ratio for non-inferiority clinical trials with risk rate endpoint

  2022cites this paper
• Selective treatment of nonsevere clinical mastitis does not adversely affect cure, somatic cell count, milk yield, recurrence, or culling: A systematic review and meta-analysis.

  2022cites this paper
• A pilot study for a smartphone app for the prevention of depression in non-professional caregivers

  2022cites this paper
• The Non-Inferiority Complex: What Do Non-Inferiority Trials Tell Us?

  2022cites this paper
• A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia

  2021cites this paper
• Efficacy of endoxifen, a protein kinase C inhibitor for acute and mixed mania: Some concerns worth considering

  2021cites this paper
• Choosing and changing the analysis scale in non-inferiority trials with a binary outcome

  2021cites this paper
• Applying the Noninferiority Paradigm to Assess Exposure‐Response Similarity and Dose Between Pediatric and Adult Patients

  2021cites this paper
• Study Designs in Clinical Research

  2021cites this paper
• Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm Neonates: A Randomized Noninferiority Trial.

  2021cites this paper
• Preliminary results of simultaneous integrated boost intensity-modulated radiation therapy based neoadjuvant chemoradiotherapy on locally advanced rectal cancer with clinically suspected positive lateral pelvic lymph nodes

  2021cites this paper
• Evidence-Based Respiratory Care

  2021cites this paper
• Improving the reporting of non-inferiority trials by incorporating non-efficacy benefits: not all non-inferiority trials are created equal

  2021cites this paper
• Understanding the merits and drawbacks of noninferiority designs in cardiovascular medicine.

  2021cites this paper
• Insulin resistance, lipid profile and low-grade inflammation in Hashimoto thyroiditis

  2020cites this paper
• Meta-analysis of Non-Inferiority and Equivalence Trials: Ignoring trial design leads to differing and possibly misleading conclusions.

  2020cites this paper
• Oral Paracetamol vs Oral Ibuprofen in Patent Ductus Arteriosus: A Randomized, Controlled, Noninferiority Trial.

  2020cites this paper
• Psychosocial Intervention With or Without Antipsychotic Medication for First-Episode Psychosis: A Randomized Noninferiority Clinical Trial

  2020cites this paper
• Race and cultural factors in an RCT of prolonged exposure and sertraline for PTSD.

  2020cites this paper
• Non-inferiority trials and non-inferiority margin: an overview

  2020cites this paper
• Abdominal aortic aneurysm: a review on the role of oral antidiabetic drugs.

  2020cites this paper
• Including Non-inferiority Trials in Contemporary Meta-analyses of Chronic Medical Conditions: a Meta-epidemiological Study

  2020cites this paper
• Assessment of non-inferiority with meta-analysis: example of hypofractionated radiation therapy in breast and prostate cancer

  2020cites this paper
• Antimicrobial Treatment Duration in Sepsis and Serious Infections.

  2020cites this paper
• baymedr: an R package and web application for the calculation of Bayes factors for superiority, equivalence, and non-inferiority designs

  2019cites this paper
• Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

  2019cites this paper
• ELEctroconvulsive therapy (ECT) vs. Ketamine in patients with Treatment-resistant Depression: The ELEKT-D study protocol.

  2019cites this paper
• The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study

  2019cites this paper
• Bibliographie

  2019cites this paper
• Non-inferiority Trial Design in Drug Development: A Primer for Cardiovascular Healthcare Professionals

  2019cites this paper
• Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation

  2019cites this paper
• Non-Inferiority Designed Cardiovascular Trials in Highest-Impact Journals: Main Findings, Methodological Quality and Time Trends.

  2019cites this paper
• How Is Rectal Cancer Managed: a Survey Exploring Current Practice Patterns in Canada

  2019cites this paper
• Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial

  2019cites this paper
• Frequency of Misinterpretation of Inconclusive Noninferiority Trials: The Case of the Laparoscopic vs Open Resection for Rectal Cancer Trials

  2019cites this paper
• Most noninferiority trials were not designed to preserve active comparator treatment effects.

  2019cites this paper
• Running head: BAYESIAN TESTS FOR BIOMEDICAL DESIGNS 1 A Comparison of the Bayesian and Frequentist Approaches to Equivalence, Non-Inferiority, and Superiority Designs

  2019cites this paper
• Designing development programs for non-traditional antibacterial agents

  2019cites this paper
• Endovascular treatment of iliofemoral deep venous thrombosis, is there enough evidence to support it? A systematic review with meta-analysis.

  2019cites this paper
• Trial design for ineffectiveness research: a mixed-methods survey

  2019cites this paper
• Restrictive Transfusion Strategy and Clinical Decision Support Practices for Reducing RBC Transfusion Overuse.

  2019cites this paper
• The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction

  2019cites this paper
• The connecting adolescents to reduce relapse (CARR) trial: study protocol for a randomized controlled trial comparing the efficacy of Groups 4 Health and cognitive behaviour therapy in young people

  2019cites this paper
• If journals embraced conditional equivalence testing, would research be better?

  2019cites this paper
• Hypothesis Testing in Superiority, Noninferiority, and Equivalence Clinical Trials: Implications in Physical Medicine and Rehabilitation

  2019cites this paper
• Quantifying Effect Sizes in Clinical Trials

  2018cites this paper
• JPEN Journal Club 33. The Type II Error.

  2018cites this paper
• Four Months of Rifampin or Nine Months of Isoniazid for Latent Tuberculosis in Adults

  2018cites this paper
• Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

  2018cites this paper
• Pilot study for supervised target detection applied to spatially registered multiparametric MRI in order to non-invasively score prostate cancer

  2018cites this paper
• Who protects participants in non-inferiority trials when the outcome is death?

  2018cites this paper
• Topical Lidocaine 2% Gel for Analgesia and Patient Comfort during Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial

  2018cites this paper
• Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2–T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME)

  2018cites this paper
• Multireader sample size program for diagnostic studies: demonstration and methodology

  2018cites this paper
• Are noninferiority studies ethically inferior?

  2018cites this paper
• The Impact of the Underlying Risk in Control Group and Effect Measures in Non-Inferiority Trials With Time-to-Event Data: A Simulation Study

  2018cites this paper
• Treatment of opioid use disorder with ibogaine: detoxification and drug use outcomes

  2018cites this paper
• Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

  2017cites this paper
• Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial

  2017cites this paper
• Effects of 2- vs 4-Week Attending Physician Inpatient Rotations on Unplanned Patient Revisits, Evaluations by Trainees, and Attending Physician Burnout

  2017cites this paper
• Conditional equivalence testing: An alternative remedy for publication bias

  2017cites this paper
• Limited-Stage Hodgkin Lymphoma: Clarifying Uncertainty.

  2017cites this paper
• Percutaneous coronary intervention versus coronary artery bypass grafting: where are we after NOBLE and EXCEL?

  2017cites this paper
• Defining the noninferiority margin and analysing noninferiority: An overview

  2017cites this paper
• Pragmatic trials : defining questions , choosing comparators , allocating treatments 1 2

  2017cites this paper
• The CONSORT guidelines for noninferiority trials should be updated to go beyond the absolute risk difference.

  2017cites this paper
• Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

  2017cites this paper
• Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators.

  2017cites this paper
• A novel method to replace classical spinal manometry: a non-inferiority study

  2017cites this paper
• Noninferiority Trials in Interventional Cardiology.

  2017cites this paper
• The Divergent Cardiovascular Effects of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Type 1 Receptor Blockers in Adult Patients With Type 2 Diabetes Mellitus.

  2017cites this paper
• Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review

  2017cites this paper
• What Do Noninferiority Trials Say About Coronary Stents?

  2017cites this paper
• ow to Compare Biologic Drugs

  2017cites this paper