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The reproducibility of biomarker research and clinical development is facing mounting pressure. In simple terms, this means that scientific results are not always easy to repeat or verify, which can slow down progress in healthcare. With the significant risks associated with false-positive and false-negative findings, understanding the factors that compromise data quality is more important than ever. One of the most critical, and often underestimated, contributors is insufficient reporting of pre-analytical procedures, the steps that take place before a sample is analyzed in the lab.
Radboudumc researchers from the Radboud Biobank and the IQ Health Science Department (research program: Biomarkers for health(care) – Discovery and implementation) examined this issue by analyzing 294 scientific publications from 2018–2023. Biomarkers are measurable indicators in blood or tissue that can help diagnose disease, predict outcomes, or guide treatment. Their analysis revealed substantial and persistent gaps in how researchers report the handling of samples: fasting status was included in only 31% of studies, the number of freeze–thaw cycles in 23%, internal sample transport in 8.5%, and centrifugation settings in just 20–35%. Although demographic and storage information were more commonly reported, these omissions occurred across journals of all prestige levels.
Why does this matter? Pre-analytical handling, such as how blood is collected, stored, transported and processed, can strongly influence measurement results. If these steps are poorly documented, other researchers cannot reliably reproduce findings, even when using the same analytical techniques. The study therefore highlights the urgent need for clearer and more standardized reporting practices to improve the reliability and reproducibility of biomarker research.
Building on these findings, the Radboudumc authors call on researchers, biobank organizations, academic institutions, policymakers, funders, and journal editors to strengthen their commitment to fit-for-purpose pre-analytical protocols. They also emphasize the importance of collaborating on reporting guidelines tailored to different analytical needs. Standardizing the recording of pre-analytical biomaterial data within biobank information management systems will be essential to support these efforts and reduce variation between studies.
Pre-analytical handling of human biomaterials ultimately determines whether samples are truly “fit for future purpose”—that is, suitable for producing robust and meaningful results, not just today but also in future research. The Dutch biobank community (BBMRI-The European Infrastructure for Biobanking | Health-RI) of Biobanks & Collections (Biobanks & Collections | Health-RI) including the Radboud Biobank, has extensive experience in developing pre-analytical protocols tailored to diverse analytical goals, thereby supporting researchers in designing rigorous studies and reporting them accurately.
Radboudumc researchers are therefore encouraged to make use of the expertise offered by the Radboud Biobank when conducting biobank-related studies. Engaging with this support not only reduces the workload for individual researchers, but also significantly improves data quality and reproducibility—ultimately accelerating scientific progress and supporting better prevention, diagnosis and treatment for patients.
About the publication
Jansen JAW, van den Brand MA, de Vegt F, Swinkels DW. Reporting of Pre-Analytical Processes in Biobanked Biomaterials: A Missed Opportunity to Address the Replicability Crisis in Clinical Biomarker Research. Biopreserv Biobank. 2025 Sep 29. Online ahead of print. PMID: 41017129
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