Establishment of the UK ME/CFS Biobank: an international resource
ME Research UK has joined forces with Action for ME the ME Association and a private donor to fund the UK’s first biobank of human blood samples for research into the causes of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The biobank will be situated at London’s Royal Free Hospital where it will be able to link in with the extensive research facilities at University College London.
In late 2011, having completed their feasibility studies, principal researchers Dr Eliana Lacerda and Dr Luis Nacul, London School of Hygiene and Tropical Medicine, began inviting patients from a dedicated disease register to submit blood specimens. The blood is specially prepared and stored for use in future biomedical studies.
Initially, blood samples will be collected from a group of patients currently enrolled in the ME/CFS Disease Register, and from healthy controls. This patient group will include people who are severely affected and bed-bound. In the longer term, other people who have been diagnosed with ME will be able to donate blood samples too.
The work will be overseen by a steering group made up of medical and academic experts, charity representatives and others.
Invaluable resource
Co-principal investigator Dr Luis Nacul, London School of Hygiene and Tropical Medicine, says, “This proposal seeks to create the infrastructure that will enable the investigation of a range of biomedical research questions; e.g. those related to the aetiology, pathophysiology, diagnosis and stratification of cases. We will achieve this by providing the research community with a well-characterised cohort of people with ME/CFS with biological samples and clinical data attached.
”
Dr Neil Abbot, Operations Director, ME Research UK, says, “Biobanks have great potential, as the 2009 House of Lords Report on Genomic Medicine made clear in 2009. The creation of a biobank infrastructure for ME/CFS, linking bio-specimens with clinical, disease and other data over the long term, is a very welcome advance. We need to know far more about the causes and consequences of this illness which has been overlooked for too long.
”
Sir Peter Spencer, Chief Executive, Action for ME, says, “This biobank will be an invaluable resource for scientific research into the different subtypes of the condition and for seeking biomarkers that could play an essential part in diagnosis – at the moment there is no definitive test for ME/CFS. I believe the biobank will quickly prove its immense value to researchers and become an indispensable part of the nation’s research effort into the illness.
”
Dr Charles Shepherd, Chief Medical Advisor, ME Association, says, “We know that people with ME/CFS have been frustrated by the lack of biomedical research in the UK. They are very supportive of research involving tissue sample collections, particularly blood samples, which they believe will lead to a better understanding of the cause of the disease and hopefully the development of specific treatments.
”
MRC support
The need for more high-quality biomedical research in ME/CFS has been recognised by the Medical Research Council (MRC). In January 2012, the MRC awarded grants totalling £1.65 million following a call for proposals under the heading Understanding the Mechanisms of CFS/ME; Professor Julia Newton, and Dr Wan Ng and colleagues (Newcastle Biomedicine, Newcastle University, UK) were two of the teams benefitting from these MRC grant awards.
Professor Stephen Holgate, Chair, MRC Population and Systems Medicine Board, says, “This initiative has my full support. 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.
”
If you would like further information, please see our Questions and Answers about the Biobank.
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 – have now 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 is 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 will be situated at London’s Royal Free Hospital where it will be able to link in with the extensive research facilities at University College London. Initially, blood samples will be collected from a group of patients currently 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 is one of six subprojects 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 will be 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 will be anonymised and confidentiality preserved, and none of the funders of the project will have access to patient data. Furthermore, applications to use the biobank for research will be 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 precise details of the registration scheme will be announced in due course.
To begin with, the study was funded to run until November 2012, and funding was subsequently provided for another year. 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, then ME Research UK, Action for ME and the ME Association and 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, would be 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.
”
