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Human tissue biobanking encompasses a wide range of activities and study designs and is critical for application of a wide range of new technologies (-“omics”) to the discovery of molecular patterns of disease and for implementation of novel biomarkers into clinical trials. Pathology is the cornerstone of hospital-based tissue biobanking. Pathologists not only provide essential information identifying the specimen but also make decisions on what should be biobanked, making sure that the timing of all operations is consistent with both the requirements of clinical diagnosis and the optimal preservation of biological products. This document summarizes the conclusions of a Pathology Expert Group Meeting within the European Biological and Biomolecular Research Infrastructure (BBMRI) Program. These recommendations are aimed at providing guidance for pathologists as well as for institutions hosting biobanks on how to better integrate and support pathological activities within the framework of biobanks that fulfill international standards.
Over the past 20 years, biobanking of human specimens has become a central activity underpinning all aspects of biomedical research as well as the development of personalized medicine [1–4]. Biobanking encompasses a wide range of specimen types and sample collection designs, ranging from population-based biobanking of specimens from healthy subjects in large, epidemiological cohorts to specific biobanking of diseased tissues obtained in the course of clinical interventions [2, 5–7]. Human tissue biobanking is of particular importance for implementation of novel biomarkers into clinical trials, as well as for the application of a wide range of new technologies (-“omics”) to the discovery and validation of new, molecular patterns of disease [8–12].
Heterogeneity and variability of pre-analytical practices is a major source of error in analyzing biobanked specimens. In recent years, large international efforts have converged towards the harmonization of standard operating procedures for biobanking, providing a basis for improving reproducibility and comparability of molecular data as well as for designing large, multicentric studies involving specimen exchanges among different centers [4, 13–17].
The most critical steps in the workflow of biospecimen acquisition and annotation for biobanking involve hospital pathologists. Pathology is the cornerstone of tissue biobanking. The most basic minimal standard for any biobanking operation is to identify and define the nature and origin of the tissues to be kept in the biobank. This requires specialized pathology expertise. Furthermore, pathologists also make decisions on what should be biobanked, making sure that the timing of all operations is consistent with both the requirements of clinical diagnosis and the optimal preservation of biological products. Pathologists also play a central role in the design of studies involving banked biospecimens and in the dialogue between clinicians and researchers. The rapid development of biobanking as an essential process in translational research and personalized medicine places strong demands on the work of the pathologist.
This document summarizes the conclusions of a Pathology Expert Group Meeting that took place in Munich in December 2008 within the European Biological and Biomolecular Research Infrastructure (BBMRI) Program [4, 18]. The experts have considered all aspects of the involvement of the pathologist in the biobanking process. They also discussed the impact of biobanking on pathology practice. The recommendations developed in the document are aimed at providing guidance for pathologists as well as for institutions hosting biobanks on how to better integrate and support pathological activities within the framework of biobanks that fulfill international standards.
Today, tissue banks have a key role in the process of biomarker and drug target discovery through the procurement of annotated specimens to innovative research programs. In addition to this research role, the use of cellular and molecular biomarkers is rapidly becoming a standard part of hospital pathology practice and of therapeutic decision schemes. Tissue banking is the key mechanism for pathologists to get involved in translating newly discovered biomarkers into clinical practice . Furthermore, tissue banking will rapidly become an intrinsic part of pathology requirements in the context of standard clinical care.
Given its strong linkage with clinical activities, tissue banking is best performed at the local level, and its sustainability requires investment in infrastructure at the local and/or regional and national levels, to avoid duplication of effort and achieve critical mass necessary to address major academic research programs, as well as to secure a strong position in addressing the needs of industry. Therefore, tissue banks must be organized in operational networks .
Implementation of biomarkers will require large networks interconnecting tissue banks, analysis and distribution platforms and several other data resources such as databases of clinical information and population-based disease registries. Biobank networks should have fully documented standard operating procedures, share tissue bank catalogues, and clear rules for access [19–21]. They should also be able to run research projects based on collections developed in several tissue banks. Such projects may be retrospective (using previously banked specimens) or prospective. Running the same, hypothesis-driven collection protocol through a large network of tissue banks that adhere to the same standards will allow assembling large case series addressing a wide range of clinical conditions. In developing such protocols, the diversity of European populations and ecological contexts is an asset for the design of sophisticated case–case comparison studies .
To achieve this vision, it is essential to perform innovative research on improving all aspects of specimen processing, including the development of quality controls applicable to retrospective collections. This requires a dedicated effort from funding agencies and from the scientific and medical publication community. Training of highly qualified tissue-banking professionals will increase the standards of tissue banking as well as the recognition of tissue banking as an integral part of biomedicine. This will also facilitate the development and dissemination of a corpus of harmonized, evidence-based tissue-banking procedures.
Conflict of interest statement We declare that we have no conflict of interest.
Open Access This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
This paper reflects the consensus of an expert working group of the Biobank and Biomolecular Research Infrastructure program that met in Munich on 17–18 December 2008. Authors are listed in alphabetical order and participated equally to this working group. The last two authors, EC and PH (IARC) convened the meeting and organized the manuscript.
Generoso Bevilacqua, Email: firstname.lastname@example.org.
Fred Bosman, Email: hc.vuhc@namsoB.derF.
Thibaut Dassesse, Email: email@example.com.
Heinz Höfler, Email: ed.nehcneum-ztlohmleh@relfeoh.
Anne Janin, Email: moc.oohay@ninaj_enna.
Rupert Langer, Email: ed.nehcneum-ut.zrl@regnaL.trepuR.
Denis Larsimont, Email: firstname.lastname@example.org.
Manuel M. Morente, Email: se.oinc@etneromm.
Peter Riegman, Email: email@example.com.
Peter Schirmacher, Email: ed.grebledieh-inu.dem@rehcamrihcS.reteP.
Giorgio Stanta, Email: gro.begci@atnats.
Kurt Zatloukal, Email: firstname.lastname@example.org.
Pierre Hainaut, Phone: +33-47-2738532, Fax: +33-47-2738322, Email: rf.crai@tuaniah.