The assessment of replicability using the sum of p-values

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Hauptverfasser: Held, Leonhard, Pawel, Samuel, Micheloud, Charlotte
Format: Preprint
Veröffentlicht: 2024
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author Held, Leonhard
Pawel, Samuel
Micheloud, Charlotte
author_facet Held, Leonhard
Pawel, Samuel
Micheloud, Charlotte
contents 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 although the original study is non-significant, in which case Type-I error rate control across both studies is no longer guaranteed. We propose an alternative method to assess replicability using the sum of p-values from the two studies. The approach provides a combined p-value and can be calibrated to control the overall Type-I error rate at the same level as the two-trials rule but allows for replication success even if the original study is non-significant. The unweighted version requires a less restrictive level of significance at replication if the original study is already convincing which facilitates sample size reductions of up to 10%. Downweighting the original study accounts for possible bias and requires a more stringent significance level and larger samples sizes at replication. Data from four large-scale replication projects are used to illustrate and compare the proposed method with the two-trials rule, meta-analysis and Fisher's combination method.
format Preprint
id arxiv_https___arxiv_org_abs_2401_13615
institution arXiv
publishDate 2024
record_format arxiv
spellingShingle The assessment of replicability using the sum of p-values
Held, Leonhard
Pawel, Samuel
Micheloud, Charlotte
Applications
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 although the original study is non-significant, in which case Type-I error rate control across both studies is no longer guaranteed. We propose an alternative method to assess replicability using the sum of p-values from the two studies. The approach provides a combined p-value and can be calibrated to control the overall Type-I error rate at the same level as the two-trials rule but allows for replication success even if the original study is non-significant. The unweighted version requires a less restrictive level of significance at replication if the original study is already convincing which facilitates sample size reductions of up to 10%. Downweighting the original study accounts for possible bias and requires a more stringent significance level and larger samples sizes at replication. Data from four large-scale replication projects are used to illustrate and compare the proposed method with the two-trials rule, meta-analysis and Fisher's combination method.
title The assessment of replicability using the sum of p-values
topic Applications
url https://arxiv.org/abs/2401.13615