The CURE-ME research team at the London School of Hygiene & Tropical Medicine, and funders Action for ME, the ME Association, ME Research UK, and a private donor, are delighted to announce the release of the Summary Report on the Establishment Phase of the UK ME/CFS Biobank (2011–2014) (read the report).

UK ME/CFS Biobank has been developed as a research resource for scientists at the London School of Hygiene & Tropical Medicine and for the international community of researchers interested in conducting ethical and progressive research on ME/CFS.

The pilot funding from the three charities and the private donor has enabled the Biobank to become established, and has led directly to a successful application for a £1 million research grant from the US National Institutes of Health, which will fund the project through to mid-2016.

As of November 2014, the Biobank held approximately 16,000 samples from over 350 participants (funded by all sources). Our hope is that these samples will contribute significantly to improved diagnosis and treatment for the many people around the world with ME/CFS. It should be ready to consider applications from researchers worldwide seeking to utilise its samples and data, subject to available funding, in 2015.

Feedback from people with ME/CFS, enrolled participants, their families, and fellow researchers has been universally positive throughout the course of the project. We would like to express our sincerest appreciation to the many people – both those with and without ME/CFS – who have so generously contributed to the Biobank by donating their time, resources, and precious energy to participate in the project.

The UK ME/CFS Biobank is a valuable resource, but long-term sustainability will be dependent on securing continuous financial support for this vital infrastructure to allow it to reach its full potential. This will involve the expansion of participant recruitment with long-term follow-up, and the processing and analysis of samples and data to test a range of study hypotheses, as well as the ongoing sharing of samples and data with the research community.

To learn more about the project, including how to participate and how you can help ensure the sustainability of the UK ME/CFS Biobank, please visit CURE-ME ME/CFS.

Quote from charity funders

The Biobank is a much-needed resource, adding capacity and creating value for the research community and ultimately for people with ME. Working collaboratively, we will increase efficiency and effectiveness which is critical if we are to achieve our vision of a world without ME.
Sonya Chowdhury, Chief Executive, Action for ME

ME Research UK is delighted to see the Biobank established, and is proud to have been one of the co-funders. The whole CURE-ME research team deserves congratulations on this achievement. The UK now has a unique ME/CFS research resource linking bio-specimens with clinical data, and we look forward to seeing it made available to scientific researchers across the world.
Dr Neil Abbot, Research & Operations Director, ME Research UK

The ME Association is delighted to have been involved in planning, developing and co-funding the UK ME/CFS Biobank. This is a vital new piece of research infrastructure that has achieved all it set out to do in the first years of operation. Special thanks must go to everyone who has donated blood samples and to our highly dedicated staff at the London School of Hygiene and Tropical Medicine and the University College London / Royal Free Hospital BioBank. We now look forward to expanding patient recruitment and opening up the biobank in 2015 to researchers who want to make use of the blood samples.
Dr Charles Shepherd, Hon. Medical Adviser, ME Association

Comment by ME Research UK

Biobanks are large collections of biological specimens (blood, tissue, cell or DNA samples) obtained from donors – patients or healthy people – who have volunteered their tissues for research. Each sample is linked with comprehensive clinical information about the donor (clinically “well-characterised” in research parlance), a fact that makes biobanks particularly useful for medical research. From the patients’ perspective, the information they provide can be used in many research studies over many years, even though samples and information are donated once only. From the perspective of the scientist, there exists a valuable database of well characterised samples, with individual privacy and confidentiality maintained, which can be accessed for approved research projects.

Over the past decade, a range of national and some multinational population-based biobanks have been established, and a large number of “disease-specific” biobanks have been formed across the world, for illnesses such as cancer, schizophrenia, heart disease, and demyelinating diseases such as MS. In the same period, two biobanks have been created to house samples from ME/CFS patients: the “SolveCFS BioBank” (part of the Genetic Alliance BioBank) run by the CFIDS Association of America; and the Whittemore Peterson Institute for neuro-immune disease repository of more than 8,000 samples and clinical information collected between 2006 and 2009. However, both ME/CFS-specific repositories are located in the USA, and their existence highlights the need for similar biobanks in Europe, particularly the UK.

For this reason, a consortium of charities – ME Research UK, Action for ME and the ME Association, with the help of a private donor – provided funds for a project to create the infrastructure for a UK ME/CFS biobank. Starting in late 2011, the primary aim of the project was to set up a disease-specific biobank consisting initially of blood samples from a cohort of well-characterised cases of ME/CFS and healthy controls.

The principal researchers on the project are Dr Eliana Lacerda and Dr Luis Nacul from the London School of Hygiene and Tropical Medicine. The biobank is situated at London’s Royal Free Hospital where it can link in with the extensive research facilities at University College London. Initially, blood samples were collected from a group of patients enrolled in the ME/CFS Disease Register, including the Case History Research on ME (CHROME) database of severely affected patients. The ME/CFS Disease Register was one of six sub-projects within the National ME/CFS Observatory; it established a pilot for a national disease register of confirmed cases of people with the illness, recruiting from 29 general practices in East Yorkshire, East Anglia and London.

All selected donors will have received a diagnosis of ME/CFS at some time in the past. However, since there are inconsistencies in how the diagnosis is made in primary, secondary or tertiary care, it is essential to have all cases newly assessed by a health professional trained in the diagnosis of ME/CFS. Patients will be assessed on whether they fulfill the CDC-1994 (Fukuda) criteria and the Canadian 2003 criteria. Since cases meeting the Canadian criteria have been shown in most cases to also meet the Fukuda criteria, this will enable the subgrouping of cases, throwing light on the appropriateness of the different classifications. In due course, comprehensive phenotyping (categorising patients based on their clinical information) may enable assessment of enrolled patients according to other clinical criteria.

Confidentiality is a key element of biobanking. Data are anonymised and confidentiality preserved, and none of the funders of the project has access to patient data. Furthermore, applications to use the biobank for research are subject to a formal approval process before anonymised blood products and clinical information about donors are issued. In the longer term, other people who have been diagnosed with ME/CFS, but not enrolled in the ME/CFS Disease Register, will be able to register an interest in donating blood samples, and the Biobank team will announce precise details of the registration scheme in due course.

In 2013, the ME/CFS Biobank was awarded over £1 million by the USA’s National Institutes of Health (read our posting). It is hoped that in future years one of the major medical research funding organisations (e.g. the Medical Research Council, the National Institute for Health Research or the Wellcome Trust) can step in to provide funding for this vital piece of research infrastructure on a long-term basis. If such core support does not materialise, the charities will work together to maintain the biobank at whatever level of activity can be achieved with available charitable funds until a major source of long term finance can be found.

As the 2009 House of Lords Report on Genomic Medicine made clear, biobanks in general have the potential to contribute significantly to our understanding of the complex interplay of genetic and environmental factors that lead to the development of common diseases. So the establishment of the UK’s first ME/CFS biobank, linking bio-specimens with clinical and disease data over the long term, is an important advance, and a step towards the long-term destination: a repository for blood and tissues from thousands of patients, linked with a post-mortem tissue bank. As Prof. Stephen Holgate, Chair, MRC Population and Systems Medicine Board, has said, “The biobank project is an excellent example of how the ME/CFS charities are working together within the national framework, established by the Medical Research Council expert group, for taking forward the UK’s research effort into this poorly understood chronic condition.”

See Questions and answers about the biobank.