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Rise of Biobanking in the EU: Evidence from the Framework Programmes
Abstract
he topic of biobanking has been anchoring in the world and Europe as well. The biobanking field today is characterised by heterogeneous entities that could be classified according to many different categories. This article aims to outline the process of the gradual embedding of the field of biobanking in the European Union (EU) from the point of view of the number of high-quality international research projects related to biobanking or biobanks as such. To identify these research projects, data from the European Commission's (EC's) database on research and innovation projects financed from Framework Programmes (FPs) of the European Union and the Horizon programme were used. It was found that the number of research and innovation projects in which biobanks played an important role more than doubled between 1994 and 2021. The highest increase in the number of biobank-related research and innovation projects occurred between 2002 – 2006 and 2007 – 2013. Several leading countries, in terms of the number of biobank related research projects, emerged during the whole period. The main actors were all countries of western Europe, characterised mostly by above-average performance in indicators such as GDP per capita, Human Development Index (HDI) or Euro Health Consumer Index (EHCI).
... Among the countries most active in participation of top-notch research projects financed by the European Commission (from Framework programs and Horizon 2020) that were related to biobank or biobanking in the period 1994-2021 were Great Britain, Germany, Italy, France, the Netherlands, and Spain, as well as Sweden, Finland, Norway, and Denmark. And after the population size adjustment, the top countries also included Iceland, Luxembourg, and Finland (Kotorova Slušná et al., 2021). ...
Background
Despite the rapid global growth of biobanking over the last few decades, and their potential for the advancement of health research, considerations specific to the sharing of benefits that accrue from biobanks have received little attention. Questions such as the types and range of benefits that can arise in biobanking, who should be entitled to those benefits, when they should be provided, by whom and in what form remain mostly unanswered. We conducted a scoping review to describe benefit sharing considerations and practices in biobanking in order to inform current and future policy and practice.
Methods
Drawing on the Arksey and O’Malley framework, we conducted a scoping review of the literature in three online databases (PubMed, Cochrane library, and Google Scholar). We extracted and charted data to capture general characteristics, definitions and examples of benefits and benefit sharing, justification for benefit sharing, challenges in benefit sharing, governance mechanisms as well as proposed benefit sharing mechanisms.
Results
29 articles published between 1999 and 2020 met the inclusion criteria for the study. The articles included 5 empirical and 24 non-empirical studies. Only 12 articles discussed benefit sharing as a stand-alone subject, while the remaining 17 integrated a discussion of benefits as one issue amongst others. Major benefit sharing challenges in biobanking were found to be those associated with uncertainties around the future use of samples and in resultant benefits.
Conclusion
Most of the benefit sharing definitions and approaches currently in use for biobanking are similar to those used in health research. These approaches may not recognise the distinct features of biobanking, specifically relating to uncertainties associated with the sharing and re-use of samples. We therefore support approaches that allow decisions about benefit sharing to be made progressively once it is apparent who samples are to be shared with, the intended purpose and expected benefits. We also highlight gaps in key areas informing benefit sharing in biobanking and draw attention to the need for further empirical research.
Human health biobanks are forms of research infrastructure that supply biospecimens and associated data to researchers, and therefore juxtapose the activities of clinical care and biomedical research. The discipline of biobanking has existed for over 20 years and is supported by several international professional societies and dedicated academic journals. However, despite both rising research demand for human biospecimens, and the growth of biobanking as an academic discipline, many individual biobanks continue to experience sustainability challenges. This commentary will summarize how the COVID-19 pandemic is creating new challenges and opportunities for both the health biobanking sector and the supporting discipline of biobanking. While the challenges for biobanks may be numerous and acute, there are opportunities for both individual biobanks and the discipline of biobanking to embrace change such that biobanks can continue to support and drive biomedical research. We will therefore describe numerous practical steps that individual biobanks and/or the discipline of biobanking can take to survive and possibly thrive in response to the COVID-19 pandemic.
Biobanking as a quickly growing branch of personalised medicine has undergone enormous progress during last two decades. Nowadays it is a well developed and structured multidisciplinary field that reflects developments and advances of biomedical research based on principles of predictive, preventive and personalised medicine (PPPM/3PM). All these trends in PPPM progress have to be translated into practice and education of new generation of scientists and healthcare givers. The importance of biobanks for multitasking research, personalised treatment, and health care systems was emphasised by many scientists and health care experts. As biobanking carries multidisciplinary character currently including more professionals than ten—twenty years ago, new generation of professional biobankers is urgently needed. To create new generation of biobankers who are fully competent to answer more and more scientific and practical questions, new study programmes, novel university curricula, and topic-dedicated courses are essential. The aim of the review is to present basic forms, trends of biobanking education offered by various biobanking related bodies and to highlight future needs. The first step is to cover all activities and duties of biobanks: acquiring, collecting, storageing and sharing biological samples and associated data, using adequate assessment for both - materials and data, taking into consideration ethical, legal, and societal issues (ELSI), responding to all stakeholder needs including pharmaceutical and other related industries, patient organisations and many other interested groups, emerging technologies and innovations as well as current and future requirements of health care systems. To compile educational programmes is a comprehensive task for all actors involved in the field of biobanking who contribute to the harmonised process of creating high educational level for future generation of biobankers. The exchange of experience involving extensive international collaboration is the way how to facilitate the process of creating optimal biobanking education.
Background:
Cohort studies with biobanks that use strict quality standards are essential requirements, not only for the development of new diagnostic and prognostic markers, but also for improving the understanding of pathophysiology of disease development, which have drawn an increasing amount of attention over the past decades. However, a bibliometric analysis of the global research on cohort biobanks is rare. The objective of this study was to evaluate the origin, current trend, and research hotspots of cohort biobanks.
Materials and Methods:
We searched the Web of Science Core Collection (WoSCC) with "biobank" and "cohort" as the topic words to retrieve English language articles published from 2009 to 2018. The CiteSpace 5.5.R2 was used to perform the cooperation network analysis, key words co-occurrence and burst detection analysis, and reference co-citation analysis.
Results:
The number of publications on cohort biobanks has increased over the past decade. Tai Hing Lam from the Department of Community Medicine, University of Hong Kong, was found to be the most productive researcher in this field. The percentage of publications in England (38.30%) was the highest all over the world. Risk, biobank, meta-analysis, cohort, disease, and so on were the most frequent keywords. Metabolic syndrome was the strongest burst keyword in this field, followed by Hong Kong, Guangzhou biobank cohort and personalized medicine. Moreover, of all the references for 932 articles included in the study, the article titled "UK biobank: an open access resource for identifying the causes of a wide range of complex diseases of middle and old age" published in PLoS Med by Sudlow et al., was the most frequently co-cited reference in this field. The largest cluster was labeled as Guangzhou biobank cohort study.
Conclusions:
This study provides an insight into cohort biobanks and the valuable information for biobankers to identify new perspectives on potential collaborators and cooperative countries/territories.
Biobanks are an extraordinary tool for research and scientific progress. Since their origin, the debate on the main technical, regulatory and ethical aspects has not stopped. The future of biobanks should take into account many factors: the need to improve the technical standards of collection, conservation and use of the sample, the usefulness of achieving forms of harmonization and common governance, the improvement of biobank networks, including through public–private partnerships and improving the sustainability of these infrastructures.
The SARS-CoV-2 pandemic, which caused a global outbreak of COVID-19 disease, has been a crisis of extraordinary proportions, causing serious impacts for research and public health. Biobanks have played a key important role in understanding the disease and response. In our article we will highlight the opportunities and risks of biobanks during and after the pandemic. The different aspects of safety and sustainability have and will be the main challenges for biobanks. Furthermore, the role of biobanks in biomedical research and public health has been emphasized as well as opportunities that have arisen for their participation in research.
When a new virus emerges and causes a significant epidemic, the emergency response relies on diagnostics, surveillance, testing, and proposal of treatments if they exist, and also in the longer term, redirection of research efforts toward understanding the newly discovered pathogen. To serve these goals, viral biobanks play a crucial role. The European Virus Archive (EVA) is a network of biobanks from research laboratories worldwide that has combined into a common set of practices and mutually beneficial objectives to give scientists the tools that they need to study viruses in general, and also to respond to a pandemic caused by emerging viruses. Taking the most recent outbreaks of the Zika virus and SARS-CoV-2 as examples, by looking at who orders what and when to the EVA, we illustrate how the global science community at large, public health, fundamental research and private companies, reorganize their activity toward diagnosing, understanding, and fighting the new pathogen.
The development of biomedical science requires the creation of biological material collections that allow for the search and discovery of biomarkers for pathological conditions, the identification of new therapeutic targets, and the validation of these findings in samples from patients and healthy people. Over the past decades, the importance and need for biobanks have increased considerably. Large national and international biorepositories have replaced small collections of biological samples. The aim of this work is to provide a basic understanding of biobanks and an overview of how biobanks have become essential structures in modern biomedical research.
Importance
The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion.
Objective
To estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data.
Design and Setting
Data were analyzed on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and development expenditure required to bring a new medicine to market. Data were accessed from the US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside published data on clinical trial success rates.
Exposures
Conduct of preclinical and clinical studies of new therapeutic agents.
Main Outcomes and Measures
Median and mean research and development spending on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate (the required rate of return for an investor) of 10.5% per year, with bootstrapped CIs. All amounts were reported in 2018 US dollars.
Results
The FDA approved 355 new drugs and biologics over the study period. Research and development expenditures were available for 63 (18%) products, developed by 47 different companies. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million (95% CI, $683.6 million-$1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5 million-$1637.5 million) in the base case analysis. Median estimates by therapeutic area (for areas with ≥5 drugs) ranged from $765.9 million (95% CI, $323.0 million-$1473.5 million) for nervous system agents to $2771.6 million (95% CI, $2051.8 million-$5366.2 million) for antineoplastic and immunomodulating agents. Data were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. Results varied in sensitivity analyses using different estimates of clinical trial success rates, preclinical expenditures, and cost of capital.
Conclusions and Relevance
This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Differences from previous studies may reflect the spectrum of products analyzed, the restricted availability of data in the public domain, and differences in underlying assumptions in the cost calculations.
Background
The aim of the present review is to discuss how the promising field of biobanking can support health care research strategies. As the concept has evolved over time, biobanks have grown from simple biological sample repositories to complex and dynamic units belonging to large infrastructure networks, such as the Pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI). Biobanks were established to support scientific knowledge. Different professional figures with varied expertise collaborate to obtain and collect biological and clinical data from human subjects. At same time biobanks preserve the human and legal rights of each person that offers biomaterial for research.
Methods
A literature review was conducted in April 2019 from the online database PubMed, accessed through the Bibliosan platform. Four primary topics related to biobanking will be discussed: (i) evolution, (ii) bioethical issues, (iii) organization, and (iv) imaging.
Results
Most biobanks were founded as local units to support specific research projects, so they evolved in a decentralized manner. The consequence is an urgent needing for procedure harmonization regarding sample collection, processing, and storage. Considering the involvement of biomaterials obtained from human beings, different ethical issues such as the informed consent model, sample ownership, veto rights, and biobank sustainability are debated. In the face of these methodological and ethical challenges, international organizations such as BBMRI play a key role in supporting biobanking activities. Finally, a unique development is the creation of imaging biobanks that support the translation of imaging biomarkers (identified using a radiomic approach) into clinical practice by ensuring standardization of data acquisition and analysis, accredited technical validation, and transparent sharing of biological and clinical data.
Conclusion
Modern biobanks permit large-scale analysis for individuation of specific diseases biomarkers starting from biological or digital material (i.e., bioimages) with well-annotated clinical and biological data. These features are essential for improving personalized medical approaches, where effective biomarker identification is a critical step for disease diagnosis and prognosis.
Biobanks have during last two decades gained an important role in the whole process of biomedical research and health care not only in Europe but also worldwide. Biobanks are one of the pillars in personalised medicine tackling all its aspects such as prevention, diagnosis, treatment and monitoring closely the specific characteristics of an individual patient. The current and future power of biobanks is the amount of samples of high-quality and related information available for current and future research of diseases, for optimising patients´ prevention, diagnosis, treatment and monitoring. The material stored in biobanks is a treasure for future technologies that will be able to utilise the currently uncovered information and knowledge. A great and growing number of samples and related information also opens new ways in how to tackle the big data problems and population studies. Biobanks play a substantial role in drug discovery, development and validation. Biobanks are not only an issue of biomedical research, but are becoming a public issue involving patients, to actively participate in biobanking with respect to ethical, legal and social issues. And, finally, biobanking as a multidisciplinary and modern field of science requires appropriate education at all levels of society. To be a world leader in the field of biobanking requires wide international and interdisciplinary collaboration. The topic-dedicated programmes released by the European Commission sustainably support biobank development in Europe and the main tool is the biggest European Union (EU) research and innovation programme ever—Horizon 2020. This article reviews the main Horizon 2020 biobanking projects, financing schemes and the future perspectives.
Quality specimens from biobanks are key resources to support reproducible research. Sustaining biobanks requires robust management. We recently published a pilot survey that indicated that over half the participating biobanks had business plans in place and another third were working on business planning. While the results provided a clue to the status of business planning in biobanking, it was concluded that a longer and more in-depth survey and analysis were required. In April 2017, an extended survey was distributed worldwide in English, French, Chinese, German, and Spanish, through multiple channels. The survey was built using the Survey Monkey tool. Our hypothesis was that those biobanks that already have a business plan also have a more professional management structure. The questions were designed to understand more details about each biobank's business operations and communications. A total of 276 biobanks participated (China 65, France 40, United States 34, Spain 27, Germany 24, Australia 23, and rest of the world 63). About two thirds of the biobanks were established in the last 10 years. The responses provided data on the size of biobanks answering the survey, their status of business planning, and how and through what mediums they are communicating with customers. Biobanks with a business plan or preparing to have one showed a clear trend of having a customer strategy for marketing the samples and communicating with customers. No trend could be seen regarding websites and activities in social media. We confirmed our hypothesis that biobanks that have or are in the process of preparing a business plan are showing a trend toward more professional structures. In the biobanking community, the business mind-set and use of the business plan as a management tool have not quite arrived.
Biobanks play an increasing role in contemporary research projects. These units meet all requirements to regard them as a one of the most innovative and up-to-date in the field of biomedical research. They enable conducting wide-scale research by the professional collection of biological specimens and correlated clinical data. Pathology units may be perceived roots of biobanking. The review aims at describing the concept of biobanks, their model of function and scientific potential. It comprises the division of biobanks, sample preservation methods and IT solutions as well as guidelines and recommendations for management of a vast number of biological samples and clinical data. Therefore, appropriate standard operating procedures and protocols are outlined. Constant individualization of diagnostic process and treatment procedures creates the niche for translational units. Thus, the role of biobanks in personalized medicine was also specified. The exceptionality of biobanks poses some new ethical-legal issues which have various solutions, in each legal system, amongst the world. Finally, distribution and activity of European biobanks are mentioned.
Worldwide, the sustainability of public health systems is challenged by the increasing number and cost of personalized therapies. Quality biological samples stored in biobanks are essential for the provision of appropriate health services and also act as a reservoir for the development of precision medicine and biotechnological innovation. Economic sustainability is a crucial factor in the maintenance of biobanking activities. Traditionally, management of biobanking is performed by health researchers and/or clinicians whose knowledge of economic issues is inadequate. On the other hand, familiarity with financial instruments used by economists is not often accompanied by a consolidated understanding of biobanking features. This article aims to be a guide for the implementation of business plans in biobanking and proposes models for the facilitation of their preparation, thus contributing to recognition of the importance of efficient management of resources of public health services.
Biobanks have been heralded as essential tools for translating biomedical research into practice, driving precision medicine to improve pathways for global healthcare treatment and services. Many nations have established specific governance systems to facilitate research and to address the complex ethical, legal and social challenges that they present, but this has not lead to uniformity across the world. Despite significant progress in responding to the ethical, legal and social implications of biobanking, operational, sustainability and funding challenges continue to emerge. No coherent strategy has yet been identified for addressing them. This has brought into question the overall viability and usefulness of biobanks in light of the significant resources required to keep them running. This review sets out the challenges that the biobanking community has had to overcome since their inception in the early 2000s. The first section provides a brief outline of the diversity in biobank and regulatory architecture in seven countries: Australia, Germany, Japan, Singapore, Taiwan, the UK, and the USA. The article then discusses four waves of responses to biobanking challenges. This article had its genesis in a discussion on biobanks during the Centre for Health, Law and Emerging Technologies (HeLEX) conference in Oxford UK, co-sponsored by the Centre for Law and Genetics (University of Tasmania). This article aims to provide a review of the issues associated with biobank practices and governance, with a view to informing the future course of both large-scale and smaller scale biobanks.
This socio-economic study is based on the widely held view that there is an inadequate supply of human biological samples that is hampering biomedical research development and innovation (RDI). The potential value of samples and the associated data are thus not being realized. We aimed to examine whether the financing of biobanks contributes to this problem and then to propose a national solution. We combined three methods: a qualitative case study; literature analysis; and informal consultations with experts. The case study enabled an examination of the complex institutional arrangements for biobanks, with a particular focus on cost models. For the purposes of comparison, a typology for biobanks was developed using the three methods. We found that it is not possible to apply a standard cost model across the diversity of biobanks, and there is a deficit in coordination and sustainability and an excess of complexity. We propose that coordination across this diversity requires dedicated resources for a national biobanking distributed research infrastructure. A coordination center would establish and improve standards and support a national portal for access. This should be financed centrally by public funds, possibly supplemented by industrial funding. We propose that: a) sample acquisition continues to be costed into projects and project proposals to ensure biobanking is driven by research needs; b) core biobanking activities and facilities be supported by central public funds distributed directly to host public institutions; and c) marginal costs for access be paid for by the user.
Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of deviation as public health was excluded from the harmonization. Biobanks seem to have substantially fewer difficulties to cope with in terms of the legal requirements in the field of sample management. This paper discusses the legal framework, experiences of different biobanks in Europe and potential ways forward. It also highlights the need for a health economic analysis of the costs and benefits of privacy protection in Europe. At the moment, policymakers seem to build their decisions on an insufficient evidence base which underestimates the potential value of biobanks for European public health. Within the past few years little progress has been achieved with regards to the development of a unified legal framework in Europe, The diversity in the legal system is also reflected in the different approaches of ethics committees towards biobanking. To secure the responsible and effective use of data and samples, more efforts are needed to come up with pathways for a solution.
Tight economic realities in clinical and research operations have spurred the need to re-examine financial models that support the infrastructure of biobanking. Finding ways to streamline operations, trim costs, and become more conscious of the carbon footprint of biobank operations has made ‘‘sustainability’’ a well-used buzzword of our time. This motivated us to organize a special symposium on biobanking sustainability at the International Society for Biological and Environmental Repositories’ (ISBER) 2014 Annual Meeting & Exhibits in Orlando, Florida. The topic crosses all of the sectors that ISBER represents, thus, we invited speakers from clinical, research, environmental, private advocacy, and government biobanks. The speakers were asked to focus on financial sustainability, share their specific experiences, and engage the ISBER meeting participants in an interactive discussion on the topic that could also be shared as a special issue on biobanking sustainability in Biopreservation and Biobanking. The goal of the symposium was to identify financial sustainability challenges that biobankers are facing in general and in specific sectors, their current solutions, and unanswered questions that may still need to be addressed. In preparation for the ISBER symposium, we asked ourselves how we define sustainability in biobanking and the reasons why sustainability in biobanking is necessary. Although we focused on financial sustainability as a topic, it is not the only dimension. Two other dimensionsof sustainability exist: social and operational (includes environmental). Social sustainabilityfocusesonthe acceptabilityof the biobankand its activities at large by the major stakeholders (e.g., successful involvement of and collaboration with engagement of the patients and donors). Operational sustainability covers different aspects of efficiency such as whether the biobank is managed professionally, its environmental footprint, and also whether the biobank collects the biospecimens and data that the po
The number of biobanks, in particular hospital-integrated tumor biobanks (HITB), is increasing all around the world. This is the consequence of an increase in the need for human biological resources for scientific projects and more specifically, for translational and clinical research. The robustness and reproducibility of the results obtained depend greatly on the quality of the biospecimens and the associated clinical data. They also depend on the number of patients studied and on the expertise of the biobank that supplied the biospecimens. The quality of a research biobank is undoubtedly reflected in the number and overall quality of the research projects conducted with biospecimens provided by the biobank. Since the quality of a research project can be measured from the impact factor of resulting publications, this also provides some indication of the quality of a research biobank. It is necessary for the biobank community to define "surrogate" quality indicators, and to establish systems of evaluation in relation to current and future resource requirements. These indicators will help in the realistic assessment of biobanks by institutions and funding bodies, and they will help biobanks demonstrate their value, raise their quality standards, and compete for funding. Given that biobanks are expensive structures to maintain, funding issues are particularly important, especially in the current economic climate. Use of performance indicators may also contribute to the development of a biobank impact factor or "bioresource research impact factor" (BRIF). Here we review four major categories of indicators that appear to be useful for the evaluation of a(m) HITB (quality, activity, scientific productivity, and "visibility"). In addition, we propose a scoring system to measure the chosen indicators.
Background
Effective translational biomedical research hinges on the operation of 'biobanks,' repositories that assemble, store, and manage collections of human specimens and related data. Some are established intentionally to address particular research needs; many, however, have arisen opportunistically, in a variety of settings and with a variety of expectations regarding their functions and longevity. Despite their rising prominence, little is known about how biobanks are organized and function beyond simple classification systems (government, academia, industry).
Methods
In 2012, we conducted the first national survey of biobanks in the U.S., collecting information on their origins, specimen collections, organizational structures, and market contexts and sustainability. From a list of 636 biobanks assembled through a multi-faceted search strategy, representatives from 456 U.S. biobanks were successfully recruited for a 30-minute online survey (72% response rate). Both closed and open-ended responses were analyzed using descriptive statistics.
Results
While nearly two-thirds of biobanks were established within the last decade, 17% have been in existence for over 20 years. Fifty-three percent listed research on a particular disease as the most important reason for establishment; 29% listed research generally. Other reasons included response to a grant or gift, and intent to centralize, integrate, or harmonize existing research structures. Biobank collections are extraordinarily diverse in number and types of specimens and in sources (often multiple) from which they are obtained, including from individuals, clinics or hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include postmortem specimens. Most biobanks are affiliated in one or multiple ways with other entities: 88% are part of at least one or more larger organizations (67% of these are academic, 23% hospitals, 13% research institutes). The majority of biobanks seem to fill a particular 'niche' within a larger organization or research area; a minority are concerned about competition for services, although many are worried about underutilization of specimens and long-term funding.
Conclusions
Effective utilization of biobank collections and effective policies to govern their use will require understanding of the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.
Progress in the debate over returning incidental findings (IFs) and individual research results (IRRs) to research participants who provide specimens and data to biobanks in genetic and genomic research requires a new tool to allow comparison across heterogeneous biobank research systems and in-depth analysis of the sources and types of findings generated for potential return. This article presents a new visual mapping tool to allow systematic and standardized depiction of (i) the specimens initially collected, (ii) the materials and data sets then created, (iii) the analyses then performed, and finally (iv) the genetic and genomic results generated, including potential IFs and IRRs. For any individual biobank research system, this sequence of four maps can be created to anticipate the sources and types of IFs and IRRs to be generated, to plan how to handle them, and then to manage them responsibly over time. We discuss how this four-map tool was created and describe its application to four national biobank systems, thereby demonstrating that this tool can provide a common platform to visualize biobank content, anticipate how IFs and IRRs will arise in a biobank research context, and inform policy development.
Genet Med 2012:14(4):385–392
Biospecimens are recognized as critical components of biomedical research, from basic studies to clinical trials and epidemiologic investigations. Biorepositories have existed in various forms for more than 150 years, from early small collections in pathology laboratories to modern automated facilities managing millions of samples. As collaborative science has developed, it has been recognized that biospecimens must be of consistent quality. Recent years have seen a proliferation of best practices and the recognition of the field of "biospecimen science." The future of this field will depend on the development of more evidence-based practices in both the research and clinical settings. As the field matures, educating a new generation of biospecimen/biobanking scientists will be an important need.
Investments in medical research and development enable the scientific progress that influences our society's body of knowledge about disease, the quality of health care, and our quality of life. Critical components of these investments include the technological and human capital factors rooted in human specimen biobanking, which can be considered foundational to driving post genomic scientific and medical research. Their importance to cancer research, information-based medicine, and quality of health care are becoming increasingly recognized by pharmaceutical companies, non profit foundations, academic researchers, and government research agencies. However, the failure to standardize tissue collection, handling, processing, and preservation so that data can be directly compared between specimen sets, as well as insufficient leveraging of the highest quality tissue samples and associated data across an array of research needs, have strained economies of scale for the biobanking field. Although existing biobanks for private research contribute economic benefits to stakeholders that can be easily substantiated, little has been published to demonstrate the positive outcomes generated from the use, application, and dissemination of their resources more broadly. Through the use of analogous examples, this article presents a rationale for how standardization and consolidation of biobanking resources would contribute to the realization of budget savings, cost avoidances, process efficiencies, and other financial impacts to both the research community and the public. A number of areas are examined, including laboratory analysis efficiencies, data modeling accuracy, infrastructure cost savings, reduced clinical trials evaluation costs, improvements in patient diagnosis, and the potential impact on industry professionalization and job creation. Areas for further study are also outlined.
Medical research to improve health care faces a major problem in the relatively limited availability of adequately annotated and collected biospecimens. This limitation is creating a growing gap between the pace of scientific advances and successful exploitation of this knowledge. Biobanks are an important conduit for transfer of biospecimens (tissues, blood, body fluids) and related health data to research. They have evolved outside of the historical source of tissue biospecimens, clinical pathology archives. Research biobanks have developed advanced standards, protocols, databases, and mechanisms to interface with researchers seeking biospecimens. However, biobanks are often limited in their capacity and ability to ensure quality in the face of increasing demand. Our strategy to enhance both capacity and quality in research biobanking is to create a new framework that repatriates the activity of biospecimen accrual for biobanks to clinical pathology.
The British Columbia (BC) BioLibrary is a framework to maximize the accrual of high-quality, annotated biospecimens into biobanks. The BC BioLibrary design primarily encompasses: 1) specialized biospecimen collection units embedded within clinical pathology and linked to a biospecimen distribution system that serves biobanks; 2) a systematic process to connect potential donors with biobanks, and to connect biobanks with consented biospecimens; and 3) interdisciplinary governance and oversight informed by public opinion.
The BC BioLibrary has been embraced by biobanking leaders and translational researchers throughout BC, across multiple health authorities, institutions, and disciplines. An initial pilot network of three Biospecimen Collection Units has been successfully established. In addition, two public deliberation events have been held to obtain input from the public on the BioLibrary and on issues including consent, collection of biospecimens and governance.
The BC BioLibrary framework addresses common issues for clinical pathology, biobanking, and translational research across multiple institutions and clinical and research domains. We anticipate that our framework will lead to enhanced biospecimen accrual capacity and quality, reduced competition between biobanks, and a transparent process for donors that enhances public trust in biobanking.
Translational cancer research is highly dependent of large series of cases including high quality samples and their associated data. Comprehensive Cancer Centers should be involved in networks to enable large-scale multi-center research projects between the centers [Ringborg, U., de Valeriola, D., van Harten, W., Llombart-Bosch, A., Lombardo, C., Nilsson, K., Philip, T., Pierotti, M.A., Riegman, P., Saghatchian, M., Storme, G., Tursz, T., Verellen, D, 2008. Improvement of European translational cancer research. Collaboration between comprehensive cancer centers. Tumori 94, 143–146.]. Combating cancer knows many frontiers. Research is needed for prevention as well as better care for those who have acquired the disease. This implies that human samples for cancer research need to be sourced from distinct forms of biobanking. An easier access to these samples for the scientific community is considered as the main bottleneck for research for health, and biobanks are the most adequate site to try to resolve this issue [Ozols, R.F., Herbst, R.S., Colson, Y.L., Gralow, J., Bonner, J., Curran Jr., W.J., Eisenberg, B.L., Ganz, P.A., Kramer, B.S., Kris, M.G., Markman, M., Mayer, R.J., Raghavan, D., Reaman, G.H., Sawaya, R., Schilsky, R.L., Schuchter, L.M., Sweetenham, J.W., Vahdat, L.T., Winn, R.J., and the American Society of Clinical Oncology, 2007. Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening: a report from the American Society of Clinical Oncology. J. Clin. Oncol. 25, 146–162.].
Biobanks are a critical piece of Research Infrastructure (RI). However, biobanks need to accept the reality of a life cycle for RIs. Until recently, strategies to sustain biobanks have been commonly focused on ways to maintain current operational models. However, sustaining biobanks as they exist today may be increasingly challenging in the face of the disruption in health and research priorities caused by the COVID-19 pandemic. In this opinion article, we review the current and emerging future drivers of biobank value for their researchers, institutions, and funders, highlighting utilization and impact of research performed using the biobank as key measures of future value. While biobanks can only indirectly influence the specific impact of the research performed, they can transform themselves to more actively redefine utilization to their advantage. Utilization means more than the balance of samples and data in versus out. Utilization means redirecting expertise to best support end users, and importantly, closing the operating gap between biobanks and their end users who seek to find the right biospecimens and data to pursue their research. We discuss the specific role of locators (those created by public investment) in closing this gap and the need for additional tools for researchers, before and subsequent to connecting with locators. For the former, we specifically propose that more support is needed to assist researchers in the decision as to how to best obtain biospecimens and navigate the options as to whether finding existing biospecimens and data held by a biobank is the optimal solution for a given project, or whether the optimal solution is either contracting with a biobank to collect samples or creating a new biobank. We believe this type of biospecimen navigator platform will help to maximize utilization of current biobank resources, and also promote the services and expertise in biobanks to better serve researchers' needs.
Although it is generally accepted that human tissue biobanks are important to facilitate progress in health and medical research, many academic biobanks face sustainability challenges. We propose that biobank sustainability is challenged by a lack of available data describing the outputs and benefits that are produced by biobanks, as reflected by a dearth of publications that enumerate biobank outputs. We further propose that boosting the available information on biobank outputs and using a broader range of output metrics will permit economic analyses such as cost-consequence analyses of biobank activity. Output metrics and cost-consequence analyses can allow biobanks to achieve efficiencies, and improve the quality and/or quantity of their outputs. In turn, biobank output measures provide all stakeholders with explicit and accountable data on biobank value, which could contribute to the evolution of biobank operations to best match research needs, and mitigate some threats to biobank sustainability.
The promise of precision medicine will only be realized if the healthcare system adapts to meet some key infrastructure needs. Among these needs are adequate biobanking practices, capable of producing the biological samples and data that precision medicine relies upon in both the research and clinical phases. Within the research domain, there have been significant improvements to biobanking processes over the past two decades, driven by increased understanding of the impact of pre-analytical variability and the critical role of biospecimen and data quality. In the era of precision medicine, biobanking to support clinical needs has similar quality requirements. The extensive knowledge and resources that have been developed by the research biobanking community are available for adoption by clinical biobanking. The challenge and opportunity now presented to the healthcare system is to adopt or adapt these resources, for example, external biobanking standards and verification programs.
Biospecimens are critical in driving health research. There is increased demand for scale and quality of biospecimens that in turn drives biobanking operational costs, influences utilization, and threatens the sustainability of individual biobanks. Biospecimen research has begun to inform the details of new biobanking standards and the steps of the biobanking process that are most important to focus on to achieve higher quality. This focus on quality is currently centered mostly on intrinsic features of biospecimens and their annotating data. This review highlights additional quality features that are important to researchers in determining the fit for purpose in their research. First, we define complex qualities as those that are mostly extrinsic to the individual biospecimen and data, and second, we provide data on the growth in demand for biospecimens with this type of quality in cancer research biobanks. Finally, we discuss why biospecimen complexity is a challenge for biobanks and utilization of existing collections, and provide examples of strategies biobanks can consider to improve their focus on this aspect of quality, as we predict that researcher demand for complex biospecimens will continue to expand in the future.
The multidisciplinary book assesses the legal and economic uncertainties surrounding the collection, storage, provision and economic development of biological samples (tumors, tissues, cells) and associated personal data related to oncology. Public, partly public and private sector actors in the field of cancer care and research hold collections supported by significant public and social funding. Under certain conditions, particularly in the context of networking (sometimes promoted by public authorities), these collections can also represent major economic assets and scientific resources. However, this involves a number of issues and institutional constraints:
• legal: the will of the source person; non-pecuniary damage; freedom to establish collections; competence in deciding on their use; legal frameworks for their distribution; desire for return on investment for public institutions, notably in terms of industrial and intellectual property.
• economic: cost of establishing and running biological resource centres; destroying resources; emerging markets; profit sharing.
• public health policy choices: prioritisation of therapeutic measures over research (fundamental or clinical trials); conservation of resources; promotion of scientific (and not commercial) value of collections.
The establishment, heritage recognition (“patrimonialisation”), development and sharing of these resources thus merit our calling into question present practices and their evolution, as well as the leverage available to public authorities (incentives, legislation, regulation) in a context where norms emerge from professional practice to become widely used in collaborative networks.
Filling a gap in the current literature on law and economics, which pays little heed to these specific considerations, this book explores these considerations to bring to light the economic implications of ethical choices and governance issues in the health sector (structural organisation of local, national and European actors in oncology).
It is intended for researchers in fields such as law, economics and biomedical sciences, as well as for public policymakers.
As part of a larger organizational study, we sought to survey biobanks in the United States. However, we encountered two problems with this population. First, no common definition of biobanks exists. Second, no census is available of these facilities from which to sample in order to implement a survey. In light of these problems, we employed a multifaceted approach using electronic searches of PubMed, RePORTER, and Google. In addition, we systematically searched for biobanks housed within universities that have NIH-designated Clinical and Translational Science Awards (CTSA). We expanded this part of the search by looking for biobanks among all members of the American Association of Medical Colleges (AAMC). Finally, we added banks to our database found previously by other researchers and banks found via correspondence with our colleagues. Our search strategy produced a database of 624 biobanks for which we were able to confirm contact information in order to conduct our online survey. Another 140 biobanks were identified but did not respond to our requests to confirm their existence or contact information. In order to maximize both the uniqueness of banks found and the greatest return on effort for each search, we suggest targeting resources that are already organized. In our work, these included the CTSA, AAMC, and part of the Google searches. We contend that our search provides a model for analysis of new fields of research and/or rapidly evolving industries. Furthermore, our approach demonstrates that with the appropriate tools it is possible to develop a systematic and comprehensive database to investigate undefined populations.
The term "biobank" first appeared in the scientific literature in 1996 and for the next five years was used mainly to describe human population-based biobanks. In recent years, the term has been used in a more general sense and there are currently many different definitions to be found in reports, guidelines and regulatory documents. Some definitions are general, including all types of biological sample collection facilities. Others are specific and limited to collections of human samples, sometimes just to population-based collections. In order to help resolve the confusion on this matter, we conducted a survey of the opinions of people involved in managing sample collections of all types. This survey was conducted using an online questionnaire that attracted 303 responses. The results show that there is consensus that the term biobank may be applied to biological collections of human, animal, plant or microbial samples; and that the term biobank should only be applied to sample collections with associated sample data, and to collections that are managed according to professional standards. There was no consensus on whether a collection's purpose, size or level of access should determine whether it is called a biobank. Putting these findings into perspective, we argue that a general, broad definition of biobank is here to stay, and that attention should now focus on the need for a universally-accepted, systematic classification of the different biobank types.
Demand for biospecimens in cancer research has increased but there are relatively few data on the trends in biospecimen usage. These data are needed to enable projection of future demand. We analyzed biospecimen usage in publications published at five-year intervals (2008, 2003, 1998, 1993, and 1988) in four cancer research journals (Cancer Research, Clinical Cancer Research, British Journal of Cancer and International Journal of Cancer). We categorized publications in three ways: 1) biospecimen utilization yes/no; 2) biospecimen cohort size; and 3) format of biospecimens used including frozen tissue, Formalin-Fixed Paraffin-Embedded (FFPE) tissue, fresh tissue, fluids, and hematological biospecimens. Biospecimens were used in 1292/3307 (39%) of publications analyzed and sufficient information was available to further classify biospecimen usage in 1228 publications. The proportion of publications in each journal using biospecimens ranged from 23% to 61% between journals, with no significant change within each journal over time. A more detailed review of tissue biospecimen use showed a significant increase in cohort sizes from 1988 to 2008 (mean 52 to 198, respectively; P < 0.0001). This reflected increased cohort sizes for both frozen and FFPE tissues from 1993 to 2008 (frozen, 59 to 119; FFPE, 66 to 194) but not fresh tissues. The relative proportion of studies using frozen or fresh tissues alone has decreased (71% to 24%) while those using FFPE alone or combined FFPE/frozen tissue cohorts has increased (24% to 72%) over this period. We conclude that the overall demand for biospecimens in cancer research has increased significantly (almost fourfold) over the past 20 years. We predict that average cohort sizes will increase by at least twofold for frozen and FFPE biospecimens over the next ten years, and that the majority of studies will be based on FFPE tissues or combined FFPE/Frozen tissue cohorts.
Biobanks contain biological samples and associated information that are essential raw materials for advancement of biotechnology, human health, and research and development in life sciences. Population-based and disease-oriented biobanks are major biobank formats to establish the disease relevance of human genes and provide opportunities to elucidate their interaction with environment and lifestyle. The developments in personalized medicine require molecular definition of new disease subentities and biomarkers for identification of relevant patient subgroups for drug development. These emerging demands can only be met if biobanks cooperate at the transnational or even global scale. Establishment of common standards and strategies to cope with the heterogeneous legal and ethical landscape in different countries are seen as major challenges for biobank networks. The Central Research Infrastructure for Molecular Pathology (CRIP), the concept for a pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), and the Organization for Economic Co-operation and Development (OECD) global Biological Resources Centres network are examples for transnational, European and global biobank networks that are described in this article.
The Global Economic Burden of Noncommunicable Diseases. A report by the World Economic Forum and the Harvard School of Public Health
- D E Bloom
Global burden of 369 diseases and injuries in 204 countries and territories. 1990-2019: a systematic analysis for the Global Burden of Disease Study
Governing Biomedical Research Resources in Europe, A report from the BBMRI project
- Biobanks Bbmri
- Public
BBMRI: an evaluation strategy for socio-economic impact assessment
- I Meijer