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Related papers: The replication of equivalence studies

200 papers

We study a statistical framework for replicability based on a recently proposed quantitative measure of replication success, the sceptical $p$-value. A recalibration is proposed to obtain exact overall Type-I error control if the effect is…

Methodology · Statistics 2023-11-10 Charlotte Micheloud , Fadoua Balabdaoui , Leonhard Held

Background: The standard regulatory approach to assess replication success is the two-trials rule, requiring both the original and the replication study to be significant with effect estimates in the same direction. The sceptical p-value…

Methodology · Statistics 2025-05-01 Jeanette Köppe , Charlotte Micheloud , Stella Erdmann , Rachel Heyard , Leonhard Held

Statistical significance of both the original and the replication study is a commonly used criterion to assess replication attempts, also known as the two-trials rule in drug development. However, replication studies are sometimes conducted…

Applications · Statistics 2024-05-31 Leonhard Held , Samuel Pawel , Charlotte Micheloud

In several large-scale replication projects, statistically non-significant results in both the original and the replication study have been interpreted as a "replication success". Here we discuss the logical problems with this approach:…

Methodology · Statistics 2023-12-19 Samuel Pawel , Rachel Heyard , Charlotte Micheloud , Leonhard Held

A new standard is proposed for the evidential assessment of replication studies. The approach combines a specific reverse-Bayes technique with prior-predictive tail probabilities to define replication success. The method gives rise to a…

Methodology · Statistics 2022-11-08 Leonhard Held

Large-scale replication studies like the Reproducibility Project: Psychology (RP:P) provide invaluable systematic data on scientific replicability, but most analyses and interpretations of the data fail to agree on the definition of…

Methodology · Statistics 2022-03-08 Kenneth Hung , William Fithian

High dimensional case control studies are ubiquitous in the biological sciences, particularly genomics. To maximise power while constraining cost and to minimise type-1 error rates, researchers typically seek to replicate findings in a…

Methodology · Statistics 2017-07-11 James Liley

Assessment of replicability is critical to ensure the quality and rigor of scientific research. In this paper, we discuss inference and modeling principles for replicability assessment. Targeting distinct application scenarios, we propose…

Methodology · Statistics 2021-05-11 Yi Zhao , Xiaoquan Wen

The two-trials rule for drug approval requires "at least two adequate and well-controlled studies, each convincing on its own, to establish effectiveness". This is usually implemented by requiring two significant pivotal trials and is the…

Methodology · Statistics 2023-11-10 Leonhard Held

Replication studies are increasingly conducted but there is no established statistical criterion for replication success. We propose a novel approach combining reverse-Bayes analysis with Bayesian hypothesis testing: a sceptical prior is…

Methodology · Statistics 2022-12-15 Samuel Pawel , Leonhard Held

Replication studies for scientific research are an important part of ensuring the reliability and integrity of experimental findings. In the context of clinical trials, the concept of replication has been formalised by the 'two-trials'…

Methodology · Statistics 2025-10-27 David S. Robertson , Thomas Jaki

Replication studies are increasingly conducted in order to confirm original findings. However, there is no established standard how to assess replication success and in practice many different approaches are used. The purpose of this paper…

Methodology · Statistics 2022-11-08 Leonhard Held , Charlotte Micheloud , Samuel Pawel

Objective: In this study, we aim to replicate an artefact-based study on software testing to address the gap. We focus on (a) providing a step by step guide of the replication, reflecting on challenges when replicating artefact-based…

Software Engineering · Computer Science 2022-04-14 Nasir Mehmood Minhas , Mohsin Irshad , Kai Petersen , Jürgen Börstler

In clinical studies upon which decisions are based there are two types of errors that can be made: a type I error arises when the decision is taken to declare a positive outcome when the truth is in fact negative, and a type II error arises…

Methodology · Statistics 2024-09-19 Andrew P Grieve

Imitation learning has enabled robots to perform complex, long-horizon tasks in challenging dexterous manipulation settings. As new methods are developed, they must be rigorously evaluated and compared against corresponding baselines…

Results of simulation studies evaluating the performance of statistical methods are often considered actionable and thus can have a major impact on the way empirical research is implemented. However, so far there is limited evidence about…

In cancer research, clustering techniques are widely used for exploratory analyses and dimensionality reduction, playing a critical role in the identification of novel cancer subtypes, often with direct implications for patient management.…

A bioequivalence study is a type of clinical trial designed to compare the biological equivalence of two different formulations of a drug. Such studies are typically conducted in controlled clinical settings with human subjects, who are…

Methodology · Statistics 2023-06-13 Kexuan Li , Susie Sinks , Peng Sun , Lingli Yang

Following an extensive simulation study comparing the operating characteristics of three different procedures used for establishing equivalence (the frequentist "TOST", the Bayesian "HDI-ROPE", and the Bayes factor interval null procedure),…

Methodology · Statistics 2022-03-15 Harlan Campbell , Paul Gustafson

The paper concerns a new statistical method for assessing dissimilarity of two random sets based on one realisation of each of them. The method focuses on shapes of the components of the random sets, namely on the curvature of their…

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