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Data Analysis Planning and Reporting for Confirmatory Multi-Lab Preclinical Trials: A Tutorial
María Arroyo-Araujo1, Clarissa F D Carneiro1, Sophie K Piper2,3
1Berlin Institute of Health, Charité - Universitätsmedizin Berlin, QUEST Center for Responsible Research, Berlin, Germany.
Biometrical Journal. Biometrische Zeitschrift
|July 27, 2026
Summary
This tutorial addresses statistical challenges in confirmatory multi-lab preclinical trials. It offers guidance on planning, analysis, and reporting to improve the transition from preclinical to clinical research.
Area of Science:
- Biostatistics
- Preclinical Research
- Translational Science
Background:
- Confirmatory multi-lab preclinical trials are crucial for advancing research from preclinical to clinical stages.
- These complex trials present significant challenges in statistical planning, analysis, and reporting.
Purpose of the Study:
- To provide a tutorial summarizing common statistical challenges in confirmatory multi-lab preclinical trials.
- To offer general guidance and adapt existing clinical trial statistical recommendations for preclinical settings.
Main Methods:
- Convening an expert group of biostatisticians and biomedical scientists.
- Incorporating statistical advice from clinical trial guidelines.
- Developing strategies for sample size calculation, handling center differences, and covariate selection.
Main Results:
- Guidance on statistical methods to account for laboratory effects.
- Recommendations for the proper reporting of preclinical trial analyses.
- Discussion of open questions to advance the statistical analysis of these studies.
Conclusions:
- The tutorial provides non-case-specific guidance to facilitate collaboration between scientists and statisticians.
- Implementing robust statistical strategies is essential for the successful analysis of confirmatory multi-lab preclinical trials.
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