Explanipedia

The Experimental Unit Information Index: Balancing Evidentiary Value and Sample Size of Adaptive Designs Open

Leonhard Held, Fadoua Balabdaoui, Samuel Pawel · 2025

Reducing the number of experimental units is one of the three pillars of the 3R principles (Replace, Reduce, Refine) in animal research. At the same time, statistical error rates need to be controlled to enable reliable inferences and deci…

Supporting Reanalysis and Reuse of Clinical Trial Data: A Case Study Open

Cora Burgwinkel, Han Chang Chiam, K. Tai, Jifan Wang, Mian Haider Ali , et al. · 2025

Background: Reproducing published findings from clinical trials is a critical component of scientific transparency, yet it remains a challenging and under-practiced task. Despite increasing emphasis on reproducibility and data reuse in res…

Edgington's Method for Random-Effects Meta-Analysis Part II: Prediction Open

David Kronthaler, Leonhard Held · 2025

Statistical inference about the average effect in random-effects meta-analysis has been considered insufficient in the presence of substantial between-study heterogeneity. Predictive distributions are well-suited for quantifying heterogene…

Edgington's Method for Random-Effects Meta-Analysis Part I: Estimation Open

David Kronthaler, Leonhard Held · 2025

Meta-analysis can be formulated as combining $p$-values across studies into a joint $p$-value function, from which point estimates and confidence intervals can be derived. We extend the meta-analytic estimation framework based on combined …

Stabilizing Thompson Sampling with Point Null Bayesian Response-Adaptive Randomization Open

Samuel Pawel, Leonhard Held · 2025

Response-adaptive randomization (RAR) methods use accumulated data to adapt randomization probabilities, aiming to increase the probability of allocating patients to effective treatments. A popular RAR method is Thompson sampling, which ra…

Combined <i>P</i> ‐Value Functions for Compatible Effect Estimation and Hypothesis Testing in Drug Regulation Open

Samuel Pawel, Małgorzata Roos, Leonhard Held · 2025

The two‐trials rule in drug regulation requires statistically significant results from two pivotal trials to demonstrate efficacy. However, it is unclear how the effect estimates from both trials should be combined to quantify the drug eff…

Knowledge, attitudes, and behaviours towards smoking among people with migration experience: a global scoping review Open

Kris Schürch, Sophie Meyer, Michele Kohli, Beatrice Minder, Doris Kopp‐Heim , et al. · 2025

Meta-regression to explain shrinkage and heterogeneity in large-scale replication projects Open

Rachel Heyard, Leonhard Held · 2025

Recent large-scale replication projects (RPs) have estimated concerningly low reproducibility rates. Further, they reported substantial degrees of shrinkage of effect size, where the replication effect size was found to be, on average, muc…

Leonhard Held and Maria Bekker-Nielsen Dunbar’s contribution to the Discussion of 'Some statistical aspects of the Covid-19 response' by Wood et al Open

Leonhard Held, Maria Bekker‐Nielsen Dunbar · 2025

A scoping review on metrics to quantify reproducibility: a multitude of questions leads to a multitude of metrics Open

Rachel Heyard, Samuel Pawel, Joris Frese, Bernhard Voelkl, Hanno Wuerbel , et al. · 2025

Reproducibility is recognized as essential to scientific progress and integrity. Replication studies and large-scale replication projects, aiming to quantify different aspects of reproducibility, have become more common. Since no standardi…

A comparison of combined <i>p</i>-value functions for meta-analysis Open

Leonhard Held, Felix Hofmann, Samuel Pawel · 2025

P -value functions are modern statistical tools that unify effect estimation and hypothesis testing and can provide alternative point and interval estimates compared to standard meta-analysis methods, using any of the many p -value combina…

Outcomes Truncated by Death in RCTs: A Simulation Study on the Survivor Average Causal Effect Open

Stefanie von Felten, Chiara Vanetta, Christoph M. Rüegger, Sven Wellmann, Leonhard Held · 2025

Continuous outcome measurements truncated by death present a challenge for the estimation of unbiased treatment effects in randomized controlled trials (RCTs). One way to deal with such situations is to estimate the survivor average causal…

Meta-regression to explain shrinkage and heterogeneity in large-scale replication projects Open

Rachel Heyard, Leonhard Held · 2025

Recent large-scale replication projects (RPs) have estimated concerningly low reproducibility rates. Further, they reported substantial degrees of shrinkage of effect size, where the replication effect size was found to be, on average, muc…

Assessing the replicability of RCTs in RWE emulations Open

Jeanette Köppe, Charlotte Micheloud, Stella Erdmann, Rachel Heyard, Leonhard Held · 2025

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 w…

A scoping review on metrics to quantify reproducibility: a multitude of questions leads to a multitude of metrics Open

Rachel Heyard, Samuel Pawel, Joris Frese, Bernhard Voelkl, Hanno Wuerbel , et al. · 2025

*Background:* Reproducibility is recognized as essential to scientific progress and integrity. Replication studies and large-scale replication projects, aiming to quantify different aspects of reproducibility, have become more common. Sinc…

Combined P-value Functions for Compatible Effect Estimation and Hypothesis Testing in Drug Regulation Open

Samuel Pawel, Małgorzata Roos, Leonhard Held · 2025

The two-trials rule in drug regulation requires statistically significant results from two pivotal trials to demonstrate efficacy. However, it is unclear how the effect estimates from both trials should be combined to quantify the drug eff…

Meta-regression to explain shrinkage and heterogeneity in large-scale replication projects Open

Rachel Heyard, Leonhard Held · 2025

Recent large-scale replication projects (RPs) have estimated concerningly low reproducibility rates. Further, they all reported substantial degrees of shrinkage of effect size, where the replica tion effect size was found to be, on average…

Closed-Form Power and Sample Size Calculations for Bayes Factors Open

Samuel Pawel, Leonhard Held · 2025

Affording reusable data: recommendations for researchers from a data-intensive project Open

Gorka Fraga González, Hester van de Wiel, Francesco Garassino, Willy Kuo, Diane de Zélicourt , et al. · 2025

Redefine statistical significance Open

Daniel J. Benjamin, James O. Berger, Magnus Johannesson, Brian A. Nosek, Eric‐Jan Wagenmakers , et al. · 2025

Stakeholder Engagement for Sustainable Open Research Data Support Services: Insights from Interviews and Surveys in Switzerland Open

Hester vd Wiel, Francesco Garassino, Zhixuan Li, Gorka Fraga González, Eva Furrer , et al. · 2024

Over the past years, the concept of Open Research Data (ORD) has gained traction as part of broader Open Science initiatives. The benefits of ORD, such as increased cost-effectiveness, transparency, and visibility, are well documented. How…

Assessing the replicability of RCTs in RWE emulations Open

Jeanette Köppe, Charlotte Micheloud, Stella Erdmann, Rachel Heyard, Leonhard Held · 2024

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 w…

Where are my data? The AFFORD workflow to create your own data index with Git, R and Quarto Open

Gorka Fraga González, Francesco Garassino, Hester vd Wiel, Willy Kuo, Diane de Zélicourt , et al. · 2024

For many researchers it may not be affordable to produce data that is Findable, Accessible, Interoperable and Reusable (FAIR). We propose a workflow to create a data index that will help data stewards and researchers curating the necessary…

Where are my data? The AFFORD workflow to create your own data index with Git, R and Quarto Open

Gorka Fraga González, Francesco Garassino, Hester vd Wiel, Willy Kuo, Diane de Zélicourt , et al. · 2024

For many researchers it may not be affordable to produce data that is Findable, Accessible, Interoperable and Reusable (FAIR). We propose a workflow to create a data index that will help data stewards and researchers curating the necessary…

Endemic-epidemic modelling of school closure to prevent spread of COVID-19 in Switzerland Open

Maria Bekker‐Nielsen Dunbar, Felix Hofmann, Sebastian Meyer, Leonhard Held · 2024

A scoping review on metrics to quantify reproducibility: a multitude of questions leads to a multitude of metrics Open

Rachel Heyard, Samuel Pawel, Joris Frese, Bernhard Voelkl, Hanno Wuerbel , et al. · 2024

*Background:* Reproducibility is recognized as essential to scientific progress and integrity. Replication studies and large-scale replication projects, aiming to quantify different aspects of reproducibility, have become more common. Sinc…

The Replication of Equivalence Studies Open

Charlotte Micheloud, Leonhard Held · 2024

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 repl…

Data analysis planning and reporting for confirmatory multi-lab preclinical trials Open

María Arroyo-Araujo, Clarissa F. D. Carneiro, Sophie K. Piper, Juliane C. Wilcke, Nicole Ellenbach , et al. · 2024

Confirmatory multi-lab preclinical trials are a powerful experimental strategy to enable decisions to transition from preclinical to clinical settings. With their complexity, such study designs pose several challenges in analysing and repo…

Data analysis planning and reporting for confirmatory multi-lab preclinical trials Open

María Arroyo-Araujo, Clarissa F. D. Carneiro, Sophie K. Piper, Juliane C. Wilcke, Nicole Ellenbach , et al. · 2024

Confirmatory multi-lab preclinical trials are a powerful experimental strategy to enable decisions to transition from preclinical to clinical settings. With their complexity, such study designs pose several challenges in analysing and repo…

A comparison of combined p-value functions for meta-analysis Open

Leonhard Held, Felix Hofmann, Samuel Pawel · 2024

P-value functions are modern statistical tools that unify effect estimation and hypothesis testing and can provide alternative point and interval estimates compared to standard meta-analysis methods, using any of the many $p$-value combina…

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