Developments in biospecimen research.

INTRODUCTION: Biobanking refers to the infrastructure, policies and practices involved in collecting, processing, storing and disseminating biological samples. Biospecimen methods research to support biobanking through evidence-based practices is now recognized as critical to the success of biobanking and translational research. SOURCES OF DATA: Data concerning biospecimen research have appeared in the literature for many years, primarily in journals and textbooks focused on clinical chemistry, epidemiology and pathology. Recently, new efforts have been initiated to support the development of evidence-based biobanking practices. AREAS OF AGREEMENT: Generally, researchers who are engaged in studies involving biospecimen collection are aware of the effects of pre-analytical variables on their downstream analyses, and they normally take steps to control those variables to publish reproducible results. Knowledge of such biospecimen research data is often unknown in the clinical setting unless the researchers are engaged in a project requiring strict protocols. AREAS OF CONTROVERSY: There is broad agreement of the need to develop evidence-based practices to achieve consistent quality for biospecimens and data. However, due to inconsistencies in the literature, there is some disagreement on whether biospecimens need to be collected according to a 'platinum' standard or local biobank standards for collecting samples as 'fit-for-purpose' will be sufficient. GROWING POINTS: New and expanded efforts, on an international basis where possible, need to be developed to better harmonize biospecimen management practices. AREAS TIMELY FOR DEVELOPING RESEARCH: Additional biospecimen methods research leading to the development of evidence-based practices is critical to translational research and personalized medicine.