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Professor Bill Ollier Overview of the UK
Biobank Project

Combining the strengths of UMIST and The Victoria
University of Manchester
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The UK Biobank

• A project to support long-term prospective
  studies of genes
• and the environment and their relationship to
  disease in
• 500,000 participants

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Our supporters
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The New Genetics
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The post-genome challenge

• We should be interested in humanitys genes
  rather than the human genome, moving from the
  individual towards the population
• Sydney Brenner

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The UK Biobank will

• Follow the health of a large group of volunteers
  for many years
• Collect information on environmental and
  lifestyle factors
• Link these to medical records and stored
  biological samples
• Samples can be used for biochemical and genetic
  analysis

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Follow-up Record linkage Registries GP
records Hospital admissions Cancer
registries Prescriptions Death
Data Sample storage Environmental
exposure Physiological variables Neuropsychiatric
evaluation Biochemical markers DNA, plasma, urine
Recruitment 500,000 participants aged 45-69
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UK population 2001
Biobank target population
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Benefits of UK Biobank

• Measure the effect of environmental,
• lifestyle and genetic risk factors in
• populations
• Understand heterogeneity within disease
• groups
• Identify important biomarker-disease
• associations

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Scientific Justification (1)

• A framework for nested case / control studies
• Investigation of a large number of conditions in
  one study
• Genetic information available for all cases
  regardless of severity
• Exposure information collected prior to
  development of disease
• Measurement of blood based molecular and
  proteomic factors using samples collected prior
  to onset

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Scientific Justification (2)

• A resource where investigation of unforeseen
  outcomes and relationships is possible
• A resource for studying the determinants of
  health as well as disease
• Potential for further investigation of groups
  defined by exposure (including genetic exposures)
• Potential to identify families within the cohort

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How will it work?

• Organisation
• Protocol
• Recruitment
• Clinic visits
• Questionnaire
• Measurements
• IT systems
• Sample storage
• Ethical considerations

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Organisational Relationships
Manchester University
MRC, Wellcome, DH, SE
Funding
Science sub-groups
Coordinating Centre
Briefing
Board of Directors
Advice
Ethics and Governance Council
CEO and staff
Advice
Science Committee
Funded contracts
Regional Collaborating Centres
Representation
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Manchester Innovation Incubator Building
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Recruitment

• GP practices as sampling frames
• Exeter system identifies names and addresses of
• eligible individuals
• NHS agencies send personalised letters and
  leaflet
• Participants respond to UK Biobank
• Central booking and helpline

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Clinic visits

• Dedicated peripatetic facilities
• 20-40 participants per day
• Receptionist, ward clerk, 2 nurses,
• 3 measurement staff
• 60 to 90 minutes in clinic
• GCP standard quality control

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Questionnaire

• Pre clinic family history and residential /
• occupational history for environmental
• exposures
• Clinic touch-screen questions partially
• supervised plus short interview
• Post clinic follow up data not coded at
• baseline, probably less complete

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Exposures and endpoints

• Baseline questionnaire
• Continuous monitoring of routine data
• Validation of endpoints from source clinical
  records using standard definitions
• Possibility of resurvey at 5 years for
  self-reported health and exposures
• Baseline biochemistry / environmental exposures
• Linkage to area-referenced environment data
• Participants can be re-approached at any time for
  further investigation

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Data Management Systems Issues
Primary Care GP Record Longitudinal Read
Coded Prescribing Diagnosis Allergies Test
Results Events
Recruitment Structured Questionnaire
Sample Processing Blood Analysis Sample
Management Genetic Information
Database
Sample Storage
Hospital Record Episodic Departmental ICD, OPCS,
SNOMed Coded
NHS National Records NWCS, Spine, Admin
Register, Screening, Payments
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Biological samples

• Blood 40mls
• Spot urine
• Toenails??

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Summary of processing protocol
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Liquid nitrogen storage facility
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Sample storage automated retrieval at -80 degrees
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Ethics and Governance

• Public consultation early and continuing
• Interim Advisory Group established
• Draft Ethics and Governance Framework published
• Independent Ethics and Governance Council
  appointed

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Ethical and Governance Framework

• Volunteers can withdraw at anytime
• Broad consent to future use
• Data security confidentiality assured
• Samples not released to others
• Full access for appropriate purposes
• Internal and external review of science
• and ethics
• Independent Ethics and Governance Council

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UK Biobank Pilot Studies Strategy
Recruitment Rate 5x?
Recruitment Rate 2x?
Main Cohort Recruitment
Target Recruitment Rate One-Person- Every-5-Mins
Recruitment Rate x
Phase-1 Clinical Pilot
Phase-2 Integrated Pilot
Main Study (Target Recruitment Close Sept-2010)
Phase-1 Molecular Pilot
Molecular Pilot Extensions (if required)
RED
AMBER
GREEN
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The Approach

• Modern, efficient methodology in
• patient recruitment, statistics, IT,
• genotyping, LIMS and genomics
• Industrial scale processes, project
• planning and quality assurance
• Distributed scientific collaboration
• strong central co-ordination and quality
• control

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