Reporting of Pre-Analytical Processes in Biobanked Biomaterials: A Missed Opportunity to Address the Replicability Crisis in Clinical Biomarker Research.

Objectives: Biobanks are crucial for clinical biomarker research, but pre-analytical processing can impact sample suitability. Insufficient reporting of pre-analytical methods can lead to invalid conclusions. Methods: This study evaluated the pre-analytical reporting quality in 294 clinical biomarker studies using biobank plasma and serum samples published from 2018 to 2023, based on the Sample PREanalytical Code and the Biospecimen Reporting for Improved Study Quality guidelines. Results: The analysis revealed frequent incomplete reporting. Key underreported elements included fasting time (reported in 31% of articles), freeze-thaw cycles (22.8%), internal transport (8.5%), and centrifugation settings (20%-35%). Demographic data (96.9%), storage temperatures (81%), and blood tube additives (82.7%) were more consistently reported. No significant correlation was found between reporting quality and journal impact factor. Conclusions: Our findings highlight the need for standardized pre-analytical reporting to improve research replicability and biomarker study quality.