Non-inferiority trials in cardiology: what clinicians need to know
PPT
Understanding the null hypothesis (H0) in non-inferiority trials
Non-Inferiority Trials: Understanding the Concepts
Non-Inferiority Trials: Understanding the Concepts
COMMENTS
Non-inferiority statistics and equivalence studies
Non-inferiority can be shown if the difference between two treatments does not cross a predefined inferiority margin. •. Non-inferiority studies need to be carefully planned; failings in the design of the study may make accepting an inferior treatment more likely.
Non-Inferiority Clinical Trials to Establish Effectiveness
The null and alternative hypotheses correspond to a null hypothesis of inferiority and an alternative hypothesis of non-inferiority, as follows:
Non-Inferiority Trials: Understanding the Concepts
Non-Inferiority Trial concepts and understanding the considerations in implementing a non-inferiority trial results into clinical practice.
Comparisons of Superiority, Non-inferiority, and Equivalence Trials
Superiority, non-inferiority, and equivalence trials are three types of widely used clinical trials. By a close examination of these hypotheses we can see that there are some similarities between trials. For example, superiority is a special case of non-inferiority.
Understanding noninferiority trials
Noninferiority trials are more complex to design, conduct, and interpret than conventional superiority trials. When planning a noninferiority trial, one should adequately understand its concept and the possible drawbacks. Choice of the noninferiority margin is critical in designing noninferiority trials.
Challenges in the Design and Interpretation of Noninferiority Trials
In this review, the authors consider the characteristics and challenges of noninferiority trial designs, including seven essential features of noninferiority trials.
Challenges in the Design and Interpretation of Noninferiority Trials
The null hypothesis in a noninferiority study states that the primary end point for the experimental treatment is worse than that for the positive control treatment by a prespecified margin, and ...
Interpreting the results of noninferiority trials—a review
Abstract Noninferiority trials are becoming increasing common, but are often poorly reported and misunderstood. A better understanding of the new components of a noninferiority trial and their ...
Non-inferiority trials in cardiology: what clinicians need to know
Clinical trials traditionally aim to show a new treatment is superior to placebo or standard treatment, that is, superiority trials. There is an increasing number of trials demonstrating a new treatment is non-inferior to standard treatment. The hypotheses, design and interpretation of non-inferiority trials are different to superiority trials. Non-inferiority trials are designed with the ...
Defining the noninferiority margin and analysing noninferiority: An
Three methods are commonly used to analyse noninferiority trials: the fixed‐margin method; the point‐estimate method; and the synthesis method. This article provides an overview of analysing noninferiority and choosing the noninferiority margin. Keywords: biostatistics, clinical trials, drug regulation, methodology, randomized controlled ...
The Non-Inferiority Complex: What Do Non-Inferiority Trials
The "null hypothesis" of a noninferiority trial is that the new treatment is worse than the standard treatment by more than the noninferiority margin. Rejecting this null hypothesis supports the claim that the new treatment is noninferior to the standard treatment.
Is Noninferior Not Inferior?
What is a non-inferiority trial margin? To answer this, ask whether you have ever weighed a tradeoff between the best version of something and an acceptable alternative. Restated, in a choice between two decisions, is one option not inferior to the other? Watch an animated video that explores the basis for non-inferiority trials, the meaning of non-inferiority margins, and the interpretation ...
Noninferiority Trials: Is a New Treatment Almost as Effective as
This Guide to Statistics and Methods describes the reasons for conducting a noninferiority trial and how to analyze and interpret the results from a trial that did.
Through the looking glass: understanding non-inferiority
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.
Superiority and non-inferiority: two sides of the same coin?
Background The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysis and interpretation.
Non-Inferiority Clinical Trials
Non-Inferiority Clinical Trials. This document provides guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing ...
Non-adherence in non-inferiority trials: pitfalls and ...
Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome ...
Through the looking glass: understanding non-inferiority
Figure 1. The role of Δ in superiority, equivalence and non-inferiority trials. Reversing the null and alternative hypotheses may be the first looking-glass problem of non-inferiority, but as we peer deeper, the backwardness seems to multiply! Trials to show superiority generally penalize the sloppy investigator (although not always; improper ...
Non-inferiority cancer clinical trials: scope and purposes underlying
Non-inferiority clinical trials (NIFCTs) aim to demonstrate that the experimental therapy has advantages over the standard of care, with acceptable loss of efficacy. We evaluated the purposes underlying the selection of a non-inferiority design in oncology and the size of their non-inferiority margins (NIFm's).
Treating severe paediatric asthma with mepolizumab or omalizumab: a
This non-inferiority (NI) trial will determine whether mepolizumab is as efficacious as omalizumab in reducing asthma attacks in children with severe therapy resistant asthma (STRA) and refractory difficult asthma (DA). ... focus will be on estimation of the treatment effect rather than testing NI hypothesis as the NI margins have not been ...
Understanding Superiority, Noninferiority, and Equivalence for Clinical
The classical approaches of the null hypothesis, sample size, statistical analysis using the P value are not justifiable for non-inferiority and equivalence trials.
WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic
To test our hypothesis, we have planned a multicentre randomised controlled trial (RCT) to examine the non-inferiority of plastic stents to a LAMS as the initial stent for EUS-guided drainage of pancreatic pseudocysts in terms of the achievement of clinical treatment success (the resolution of a pseudocyst).
Artificial intelligence and radiologists in prostate cancer detection
Our primary hypothesis was the non-inferiority of stand-alone AI diagnosis with respect to PI-RADS (2.1) and the standard of care. When confirmed, we tested a secondary hypothesis for the superiority of the AI system. We evaluated the diagnostic performance of the AI system and radiologists, according to their case-level predictions of ...
Understanding the null hypothesis (H0) in non-inferiority trials
Different possible scenarios of the results of a non-inferiority clinical trial. ∆ is the non-inferiority margin In this study, the authors claimed the superiority of the lactate strategy over the ScvO 2 strategy because the lactate group had a significantly lower mortality compared with the ScvO 2 group (18.3 versus 27.9%, P = 0.033).
Understanding Equivalence and Noninferiority Testing
In hypotheses testing, the research or alternative hypothesis represents what the study aims to show. The null hypothesis is the opposite of the research hypothesis and is what the investigator hopes to disprove.
Non-inferiority clinical trials: Practical issues and current
Non-inferiority clinical trials aim to demonstrate that the test product is no worse than the comparator by more than a pre-specified small amount. There are several fundamental differences between non-inferiority and superiority trials. Some practical issues concerning the non-inferiority trials are assay sensitivity, choice of the non ...
IMAGES
COMMENTS
Non-inferiority can be shown if the difference between two treatments does not cross a predefined inferiority margin. •. Non-inferiority studies need to be carefully planned; failings in the design of the study may make accepting an inferior treatment more likely.
The null and alternative hypotheses correspond to a null hypothesis of inferiority and an alternative hypothesis of non-inferiority, as follows:
Non-Inferiority Trial concepts and understanding the considerations in implementing a non-inferiority trial results into clinical practice.
Superiority, non-inferiority, and equivalence trials are three types of widely used clinical trials. By a close examination of these hypotheses we can see that there are some similarities between trials. For example, superiority is a special case of non-inferiority.
Noninferiority trials are more complex to design, conduct, and interpret than conventional superiority trials. When planning a noninferiority trial, one should adequately understand its concept and the possible drawbacks. Choice of the noninferiority margin is critical in designing noninferiority trials.
In this review, the authors consider the characteristics and challenges of noninferiority trial designs, including seven essential features of noninferiority trials.
The null hypothesis in a noninferiority study states that the primary end point for the experimental treatment is worse than that for the positive control treatment by a prespecified margin, and ...
Abstract Noninferiority trials are becoming increasing common, but are often poorly reported and misunderstood. A better understanding of the new components of a noninferiority trial and their ...
Clinical trials traditionally aim to show a new treatment is superior to placebo or standard treatment, that is, superiority trials. There is an increasing number of trials demonstrating a new treatment is non-inferior to standard treatment. The hypotheses, design and interpretation of non-inferiority trials are different to superiority trials. Non-inferiority trials are designed with the ...
Three methods are commonly used to analyse noninferiority trials: the fixed‐margin method; the point‐estimate method; and the synthesis method. This article provides an overview of analysing noninferiority and choosing the noninferiority margin. Keywords: biostatistics, clinical trials, drug regulation, methodology, randomized controlled ...
The "null hypothesis" of a noninferiority trial is that the new treatment is worse than the standard treatment by more than the noninferiority margin. Rejecting this null hypothesis supports the claim that the new treatment is noninferior to the standard treatment.
What is a non-inferiority trial margin? To answer this, ask whether you have ever weighed a tradeoff between the best version of something and an acceptable alternative. Restated, in a choice between two decisions, is one option not inferior to the other? Watch an animated video that explores the basis for non-inferiority trials, the meaning of non-inferiority margins, and the interpretation ...
This Guide to Statistics and Methods describes the reasons for conducting a noninferiority trial and how to analyze and interpret the results from a trial that did.
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.
Background The classification of phase 3 trials as superiority or non-inferiority has become routine, and it is widely accepted that there are important differences between the two types of trial in their design, analysis and interpretation.
Non-Inferiority Clinical Trials. This document provides guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing ...
Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome ...
Figure 1. The role of Δ in superiority, equivalence and non-inferiority trials. Reversing the null and alternative hypotheses may be the first looking-glass problem of non-inferiority, but as we peer deeper, the backwardness seems to multiply! Trials to show superiority generally penalize the sloppy investigator (although not always; improper ...
Non-inferiority clinical trials (NIFCTs) aim to demonstrate that the experimental therapy has advantages over the standard of care, with acceptable loss of efficacy. We evaluated the purposes underlying the selection of a non-inferiority design in oncology and the size of their non-inferiority margins (NIFm's).
This non-inferiority (NI) trial will determine whether mepolizumab is as efficacious as omalizumab in reducing asthma attacks in children with severe therapy resistant asthma (STRA) and refractory difficult asthma (DA). ... focus will be on estimation of the treatment effect rather than testing NI hypothesis as the NI margins have not been ...
The classical approaches of the null hypothesis, sample size, statistical analysis using the P value are not justifiable for non-inferiority and equivalence trials.
To test our hypothesis, we have planned a multicentre randomised controlled trial (RCT) to examine the non-inferiority of plastic stents to a LAMS as the initial stent for EUS-guided drainage of pancreatic pseudocysts in terms of the achievement of clinical treatment success (the resolution of a pseudocyst).
Our primary hypothesis was the non-inferiority of stand-alone AI diagnosis with respect to PI-RADS (2.1) and the standard of care. When confirmed, we tested a secondary hypothesis for the superiority of the AI system. We evaluated the diagnostic performance of the AI system and radiologists, according to their case-level predictions of ...
Different possible scenarios of the results of a non-inferiority clinical trial. ∆ is the non-inferiority margin In this study, the authors claimed the superiority of the lactate strategy over the ScvO 2 strategy because the lactate group had a significantly lower mortality compared with the ScvO 2 group (18.3 versus 27.9%, P = 0.033).
In hypotheses testing, the research or alternative hypothesis represents what the study aims to show. The null hypothesis is the opposite of the research hypothesis and is what the investigator hopes to disprove.
Non-inferiority clinical trials aim to demonstrate that the test product is no worse than the comparator by more than a pre-specified small amount. There are several fundamental differences between non-inferiority and superiority trials. Some practical issues concerning the non-inferiority trials are assay sensitivity, choice of the non ...