Schweitzer Fachinformationen
Wenn es um professionelles Wissen geht, ist Schweitzer Fachinformationen wegweisend. Kunden aus Recht und Beratung sowie Unternehmen, öffentliche Verwaltungen und Bibliotheken erhalten komplette Lösungen zum Beschaffen, Verwalten und Nutzen von digitalen und gedruckten Medien.
Biobanks ensuring the governance and management of biological resources have become essential entities. The development of biotechnologies, the increased prevalence of biological drugs and the identification of biomarkers associated with molecular classifications of tissue lesions make it essential to have organized access to human biological samples, which have become precious and rare. The digital era and the production of massive data that comes with it have rendered biobanks the guarantors of the reproducibility of experiments and of the overall quality of medical research.
Biobanks in Healthcare explores the upheaval linked to the massive deployment of digital health and precision medicine. The future of health biology lies in the deployment of biobanks in fields that have yet to be explored, putting them at the forefront of this extraordinary 21st-century research adventure.
Nicole Arrighi is an associate professor at Côte d'Azur University and teacher-researcher in the Biology and Pathologies of Melanocytes team (C3M, Nice), France. She is also the deputy director of the Biobanks and Complex Data Management master's program.
Paul Hofman is a professor and hospital practitioner in pathology at Côte d'Azur University, France. He is the director of the Laboratory of Clinical and Experimental Pathology and the biobank at the Nice University Hospital. He leads a research team at the Institute for Research on Cancer and Aging and the OncoAge University Hospital Federation.
Foreword ix
Acknowledgments xiii
Introduction xvii
Chapter 1 Biobanks, a Source of Human Samples and Health Data 1
1.1 From the collection of biological samples to the concept of a biobank 3
1.1.1 The biobank concept 6
1.1.2 The first biobank described in the Framingham study 7
1.1.3 Classification of human sample biobanks 8
1.2 Mapping of biobanks 13
1.2.1 The large catalog of European biobanks 15
1.2.2 International biobanks 17
1.2.3 The first results from the megacohorts 26
1.3 Process management in biobanks 34
1.3.1 Sample quality, the priority of biobanks 35
1.3.2 Protection of the human person and personal information 41
Chapter 2 Biobanks in the Digital Age and Precision Medicine 51
2.1 Medical imaging biobanks 52
2.1.1 The UK Biobank prospective medical imaging study 53
2.1.2 The Rotterdam prospective imaging study 56
2.1.3 The German National Cohort 59
2.1.4 The European medical imaging biobank project 63
2.2 Radiomics data powered by digital technology 65
2.2.1 A multitude of application areas for biomarkers 67
2.2.2 Biomarkers in quantitative imaging 69
2.2.3. Artificial intelligence for automatic reading of medical images .. 74
2.3 The infallible traceability of biobank data 83
2.3.1 Automated sample flow, essential for population biobanks 83
2.3.2 Computerized management of clinicobiological annotations 85
2.3.3 International Biobanks of Excellence or Expert Centers 90
2.3.4 The FAIR principles of health data management 98
Chapter 3 The Biobanking Lexicon 101
3.1 Accreditation 101
3.2 Anonymization (or de-identification) 104
3.3 ANSM, the French National Agency for the Safety of Medicines and Health Products 104
3.4 Artificial intelligence 104
3.5 BBMRI, the coordinating center for European biobanks 104
3.6 BBMRI-ERIC, the research infrastructure for biobanking 105
3.7 BBMRI-ERIC Biobank of Excellence or Expert Center 105
3.8 Biobank information management system (BIMS) 105
3.9 Biobank or biological resource center (BRC) 106
3.10 Biomarker 106
3.11 Biospecimen 106
3.12 Buffy coat 108
3.13 Certification 108
3.14 Clinical biobank 109
3.15 Clinical research or clinical trials 109
3.16 Clinical trial sponsor 109
3.17 CNIL, the French National Commission for Information Technology and Civil Liberties 110
3.18 Cohort and megacohort 110
3.19 Collection of biological samples 110
3.20 Companion test 111
3.21 Computed tomography (CT) 111
3.22 CPP, the French Committee for the Protection of Individuals 111
3.23 Data protection officer (DPO) 111
3.24 Diagnostic biomarker 112
3.25 Digital health or e-health 112
3.26 Electronic case report form (eCRF) 112
3.27 ESBB, the European, Middle Eastern and African Society for Biopreservation and Biobanking 113
3.28 FDA, the US Food and Drug Administration 113
3.29 Formalin-fixed, paraffin-embedded (FFPE) tissue 113
3.30 Free and informed consent 114
3.31 General Data Protection Regulation (GDPR) 114
3.32 Imaging biobank 115
3.33 Imaging biomarker 115
3.34 ISBER, the International Society for Biological and Environmental Repositories 115
3.35 ISO 20387:2018 Biotechnology - biobanking - general requirements for biobanking 115
3.36 Laboratory information management system (LIMS) 116
3.37 Liquid biopsy (in oncology) 116
3.38 Machine learning and deep learning 118
3.39 Medical imaging 118
3.40 Microbiota 118
3.41 Monitoring biomarker 122
3.42 MTA or biological material transfer contract 122
3.43 Nf S96-900 124
3.44 Omics 124
3.45 Peripheral blood mononuclear cells (PBMCs) 124
3.46 Personalized or individualized medicine 125
3.47 Pharmacodynamic/response biomarker 125
3.48 Population biobanking 125
3.49 Positron emission tomography (PET) 125
3.50 Pre-analytical phase 126
3.51 Precision medicine 126
3.52 Predictive biomarker 127
3.53 Prognostic biomarker 127
3.54 Prospective study/survey 127
3.55 Quality management system (QMS) 127
3.56 QR code 128
3.57 Radiomics 128
3.58 Region of interest or volume of interest (ROI/VOI) 128
3.59 Retrospective study/survey 128
3.60 Standard operating procedures (SOPs) 128
3.61 Stratified medicine 129
3.62 The process of fixation and paraffin embedding 129
3.63 Translational research 130
3.64 Tumor biobank 131
Conclusion 133
Glossary 137
References 145
Index 159
Research is based on several foundations: fundamental concepts, cellular and animal models, validation of discoveries obtained in laboratories through a "translational" approach and then, depending on the sector of interest, clinical or applied research or research carried out in silico using databases. Depending on the research topics, it is necessary to achieve a continuum between the discovery of new cellular mechanisms and an application in the living world, whether it is the plant, microbial or animal and human world.
One of the unavoidable links between basic research and its various applications is the use of different biological resources, whether they come from plants, microbes, animals or healthy or sick human beings [ALD 19, VAU 19]. From time immemorial, researchers have needed to analyze these different biological resources to validate their hypotheses or observations made with cellular models. Several purposes have progressively emerged, such as better understanding of developmental biology or of the mechanisms of cell death, growth or transformation. One of the most successful examples of the use of biological resources is the discovery of biomarkers of human diseases, which can be biomarkers for diagnostic, prognostic or predictive purposes in a therapeutic response [BAR 20, HEW 11]. While the these biological resources were initially used in a poorly controlled manner and without any real established rules, several reflection policies have gradually led to the establishment of a controlled and rigorous operation. Thus, the notion of a collection was born, associated with the need to control use and the necessary storage spaces. In recent decades, these different collections have been associated with the creation of biological resource centers (BRCs), still called "biobanks" today, the structuring of which has been progressive, and they have become essential "tools" in the world of research [WAT 19].
Biobanks have evolved in recent years and are now professionalized and complex structures whose operation is subject to national and international regulations. These biobanks can function as secure storage areas for biological collections (called "biorepositories"), making samples available for research projects. They can also be organized as Expert Centers, and thus both offer services to researchers (thanks to the existence of technical platforms) and enable scientific collaboration (thanks to unique knowledge). Biobanks can also develop their own research projects on specific topics, in particular on the control, management and use of biological samples, essentially with the aim of optimizing their operations and their service offer [WAS 18a].
Biobanks and collection policy have evolved over time. A typical example is the evolution of biobanks collecting patient samples. At first, many samples were accumulated and frozen, in particular tumor samples. The question of the quality of these thousands of stored samples then arose. Indeed, the discovery and/or validation of the different markers proved to be totally dependent on the reproducibility of the analyses on perfectly preserved samples. Finally, the need to acquire more and more associated or targeted data modified the functioning of biobanks by requiring the development of multiple and complex databases. Indeed, one of the key points associated with making biological samples available for research projects is now the need to associate very precise and relevant data with them. The world of biobanking has therefore evolved progressively over the last few decades, with this field becoming a medical specialty in its own right. Thus, schematically, the activity of biobanks has passed through several stages, from the "biobank 1.0" (massive collection activity often without any preconceived ideas and based on "quantitative" data) to the "biobank 2.0" (where the quality of samples is considered crucial along with the implementation of the control of the parameters of the pre-analytical phase), and finally the "biobank 3.0" (integrating several imperatives, in particular the controlled management of clinicobiological data, the anticipation of requests and the control of the business model) [DOU 17, ELL 15, LIN 20, SIM 14]. Thus, the creation and construction of a biobank-type structure must nowadays meet strict requirements, in particular associated with a collection strategy and planning of the use of stored samples [BAI 16, HOF 13].
The diversity of expertise required to generate the data associated with the samples, their integration and their analysis necessitate a rethinking of the organization and structuring of biobanks in order to address the services of specialists in different fields, notably medical, biological, imaging, statistics, bioinformatics and mathematics. This change must concern, at the national or international level, biobanks involved in the collection, integration and analysis of complex data. The concept of next generation biobanks (NGBs) is gradually emerging. An NGB must be able to combine huge databases hosting phenotypic, behavioral, familial, imaging, omics, radiomics and biological data from different centers. Operating an NGB requires overcoming several challenges, the first of which is that of computing infrastructures capable of processing tetrabits, pentabits and exabits. In addition, a suite of appropriate analysis methods and algorithms must be developed. Moreover, these NGBs are now accompanied by a paradigm shift from the analysis of data from a large number of patients to the analysis of a large volume of data from a single subject ("Big Data" vs. "Fat Data"). A crucial aspect for biobanks is their sustainability, taking into account the fact that the business model of these structures is often fragile [RAO 19, VAU 11]. Indeed, the operation of a biobank today requires a dedicated and qualified staff, a secure and expensive infrastructure and equipment that must be renewed regularly in order to maintain the quality of the collections.
There are more and more biobanks throughout the world and the number of collections that can be made available to researchers is increasing, which may lead to a gradual decrease in demand for certain biobanks due to competition. In this context, in order to be competitive, a biobank must make organizational and strategic choices. It is difficult to maintain a high level of expertise in several fields of activity, and focusing on a limited number of pathologies certainly makes it possible to concentrate on the completeness of the collections and to associate complete clinical and biological data, the latter becoming increasingly complex.
An essential point is to obtain the signed consent of patients to use their sample for research purposes. This key point must be associated with an internal process specific to each biobank, which must be perfectly mastered and conducted in consultation with the clinical services. The external visibility of a biobank and its recognition are increased when the partners of a biobank have access to different forms of expertise (e.g. histological diagnosis performed by senior pathologists in the field of pathology concerned; expertise in molecular biology and accessible genomic databases). Focusing on one or a few pathologies also makes it possible to associate, for the same patients, diversified collections of tissues (fixed and frozen) and biofluids (plasma, sera, buffy coat, whole blood, urine, other fluids, etc.). Clinical data and in particular the follow-up of patients according to the different successive treatments or the collection of events (progression, metastasis, death) can be more easily integrated into the biological databases [WAT 17]. In this context, it is often easier to join a national or international network of experts in the same field.
Certification or accreditation of the biobank according to national or international standards is also essential to the robustness of its operation and the quality of the service provided. A competitive biobank must also develop innovative projects, particularly in relation to the pharmaceutical and biotechnology industries. Different projects can allow for the transfer of the results of the innovation thus acquired to clinical practice, after a validation phase carried out with biological samples. Thus, the visibility of a biobank vis-à-vis different partners and/or applicants for biological samples can benefit from the implementation of performance indicators that must be adapted to the structure concerned and its ambitions [HOF 13].
Several challenges are emerging in the near future for biobanks, and these structures must meet a certain number of common objectives. For example, data from different databases or documents (pathological anatomy, molecular biology, imaging, clinical and therapeutic data) have to be gathered (or used) in a single accessible source. It will also be necessary to integrate, store and process complex and often very heterogeneous data volumes. One of the challenges is the sharing and access to information, which must be secure and based on perfectly de-identified data. This access could be envisaged for external partners wishing to know the available samples and the associated complex data. In view of these rapid developments and a change in the activities related to the biobanking profession, it is therefore crucial to continue or develop...
Dateiformat: ePUBKopierschutz: Adobe-DRM (Digital Rights Management)
Systemvoraussetzungen:
Das Dateiformat ePUB ist sehr gut für Romane und Sachbücher geeignet – also für „fließenden” Text ohne komplexes Layout. Bei E-Readern oder Smartphones passt sich der Zeilen- und Seitenumbruch automatisch den kleinen Displays an. Mit Adobe-DRM wird hier ein „harter” Kopierschutz verwendet. Wenn die notwendigen Voraussetzungen nicht vorliegen, können Sie das E-Book leider nicht öffnen. Daher müssen Sie bereits vor dem Download Ihre Lese-Hardware vorbereiten.Bitte beachten Sie: Wir empfehlen Ihnen unbedingt nach Installation der Lese-Software diese mit Ihrer persönlichen Adobe-ID zu autorisieren!
Weitere Informationen finden Sie in unserer E-Book Hilfe.