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Related papers: Assessing replicability with the sceptical p-value…

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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

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

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

Replication studies are increasingly conducted to assess the credibility of scientific findings. Most of these replication attempts target studies with a superiority design, but there is a lack of methodology regarding the analysis of…

Methodology · Statistics 2024-12-13 Charlotte Micheloud , Leonhard Held

Verifying that a statistically significant result is scientifically meaningful is not only good scientific practice, it is a natural way to control the Type I error rate. Here we introduce a novel extension of the p-value - a…

Methodology · Statistics 2018-07-04 Jeffrey D. Blume , Lucy DAgostino McGowan , William D. Dupont , Robert A. Greevy

We are concerned with testing replicability hypotheses for many endpoints simultaneously. This constitutes a multiple test problem with composite null hypotheses. Traditional $p$-values, which are computed under least favourable parameter…

Methodology · Statistics 2020-02-26 Anh-Tuan Hoang , Thorsten Dickhaus

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

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 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

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

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

Adapting the final sample size of a trial to the evidence accruing during the trial is a natural way to address planning uncertainty. Designs with adaptive sample size need to account for their optional stopping to guarantee strict type-I…

In a recent simulation study, Goodman et al. (2019) compare several methods with regard to their type I and type II error rates in case of a thick null hypothesis that includes all values that are practically equivalent to the point null…

Methodology · Statistics 2022-06-07 Robin Tim Dreher , Leona Hoffmann , Arne Kramer-Sunderbrink , Peter Pütz , Robin Werner

One class of statistical hypothesis testing procedures is the indisputable equivalence tests, whose main objective is to establish practical equivalence rather than the usual statistical significant difference. These hypothesis tests are…

Methodology · Statistics 2024-01-04 Daniel Ochieng

In multiple testing several criteria to control for type I errors exist. The false discovery rate, which evaluates the expected proportion of false discoveries among the rejected null hypotheses, has become the standard approach in this…

Methodology · Statistics 2023-11-03 Jacobo de Uña-Álvarez

There is a well-known problem in Null Hypothesis Significance Testing: many statistically significant results fail to replicate in subsequent experiments. We show that this problem arises because standard `point-form null' significance…

Methodology · Statistics 2025-02-06 Fintan Costello , Paul Watts

Increased availability of data and accessibility of computational tools in recent years have created unprecedented opportunities for scientific research driven by statistical analysis. Inherent limitations of statistics impose constrains on…

Genomics · Quantitative Biology 2016-09-13 Olga A. Vsevolozhskaya , Gabriel Ruiz , Dmitri V. Zaykin

Much of science is (rightly or wrongly) driven by hypothesis testing. Even in situations where the hypothesis testing paradigm is correct, the common practice of basing inferences solely on p-values has been under intense criticism for over…

Methodology · Statistics 2015-12-31 M. J. Bayarri , Daniel J. Benjamin , James O. Berger , Thomas M. Sellke

Replicability issues -- referring to the difficulty or failure of independent researchers to corroborate the results of published studies -- have hindered the meaningful progression of science and eroded public trust in scientific findings.…

As a convention, p-value is often computed in frequentist hypothesis testing and compared with the nominal significance level of 0.05 to determine whether or not to reject the null hypothesis. The smaller the p-value, the more significant…

Methodology · Statistics 2020-02-25 Haolun Shi , Guosheng Yin
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