STRATUM' - Strategic Tissue Repository Alliance through Unified Methods

Background
The use of high quality human biological samples with associated data and their effective life cycle management (biobanking) are increasingly critical to our understanding of the underlying mechanisms of disease and the development of diagnostics. However, despite much progress, the inadequate supply of quality samples and the excessive complexity in the organisation of biobanks is hampering biomedical research. This is partly due to a lack of unified methods and approaches being applied across samples’ life cycle: acquisition, sample processing, storage, provision and use.
Organisation
Strategic Tissue Repository Alliances Through Unified Methods (STRATUM) is a public-private, 18-month project to provide building blocks for a national biobanking solution that facilitates biomedical research. The project is funded by the private sector and the government, via the Technology Strategy Board. There are six partners: two UK pharmaceutical companies (AstraZeneca, GlaxoSmithKline), a clinical diagnostic SME (Lab21) and the universities of Manchester, Nottingham and Leicester. A Project Steering Committee, with overall oversight of STRATUM has representatives from each partner, the MRC, the Royal College of Pathologists, British In Vitro Diagnostics Association and Patients. Operationally a Project Lead is responsible for the co-ordination and overall delivery of the project with Work Package leads focusing on specific areas.
As biobanking is so broad in its application, one of the key factors for the success of STRATUM is to engage with the wide variety of disciplines and groups across both the public and private sectors, which have an interest in or could be impacted by the deliverables. This engagement is essential for the exploitation of STRATUM, from the delivery of the building blocks for biobanking, and thence enable benefits to be delivered across R&D and healthcare in general. As such, all deliverables from STRATUM will be the result of extensive consultation with experts and the public in the relevant areas, which will be enabled by a communication specialist.
Aim and Objectives
The aim of STRATUM is to facilitate the co-ordination of biobanking to support innovative research, in the UK by addressing the problems defined above.
It will increase the effectiveness of sample provision to ensure that UK research institutions, pharmaceutical, biotechnology and diagnostic companies have the ability to access the large numbers of well-characterised samples with data, currently being held in individual collections. It will result in operating to agreed standards and a cost model for sample life cycle management.
Ultimately, this approach should enable diagnostic companies, either singly or in partnership with pharmaceutical firms and research institutes, to develop companion diagnostics that are critical to delivering the personalised healthcare agenda.
Scope and Deliverables
To achieve this, STRATUM aims to define a framework of policy in biobanking, which will focus on governance, access, infrastructure and ethical principles for biobanking. This framework will be based on existing best practice and consensus across the diverse range of stakeholders involved in biobanking. Overall, the project focuses on: assessing public opinion ( biobanking and the use of samples); developing standards (for tissue sample characterisation and life cycle management); creating network requirements (biobank catalogue/directory); exploring financial arrangements (cost model); defining consent templates and enabling engagement (through two-way communication).
The scope for individual work packages’ is outlined below:
Public Engagement
• To investigate the acceptability to donate samples and towards different models of consent for the use of samples, with the general public
• To explore the attitudes, including barriers and drivers, within the NHS and biobanking community in collecting tissues samples
The outcome of these findings will enable and help define the policy.
Policy
• To deliver a biobanking policy that provides the framework for governance, infrastructure and standards for human biological sample life cycle management across the UK; thereby enabling processes to be established that amongst other things enable increased visibility of sample collections (and unidentifiable data) with rules of access to facilitate equitable sharing of samples across the value chain and to provide assurance to donors that their samples’ use will be maximised.
Sample Life Cycle Management Standards
• To deliver standards for the life cycle management of respiratory and generic samples, including derivatives (acquisition, processing, storage, disposal)
• To publish the standards with a process for their adoption and maintenance, with metrics for measuring compliance with the standards, to be able to improve sample quality and provide feedback for continuous improvement in HBS life cycle management
Register for Samples/Minimum Datasets
• To deliver a user requirements document for a system that will enable collections of samples with associated metadata to be registered and viewed via a single, secure, web-based user interface
• To evaluate existing and proposed platforms and their operating environments against the user requirements and provide recommendations on how the user requirements can be implemented, defined in the STRATUM Exploitation Plan
• To define the minimum datasets i.e. meta data/attributes that describe and characterise collections, donors and samples (respiratory and generic samples) to support the creation of a sample collection inventory (for use as a data in the register) and a histo-library of characterised samples, enabling researchers to identify samples and select them for research, in accordance with the consent
• To pilot the recommended datasets for respiratory collections to inform the development of a register
Cost Model
• To increase understanding of the overall costs associated with biobanking, identify hidden costs, highlight organisational models that work, and explore relationships between key variables (e.g. funding mechanisms and optimal access arrangements).
• The analysis aims to make the costs and benefits of coordinating biobanking nationally more explicit, in order to develop an ‘ideal’ cost-model for a national research infrastructure that will be defined in a report that will be taken forward to the exploitation strategy and plan for STRATUM
Consent
• To define consent templates that are consistent with the outputs of the public engagement and policy
If you would like further information about STRATUM, please do not hesitate to contact:
Julie Corfield (Areteva) at juliecorfield@areteva.com