Human Biospecimen Database

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Human Biospecimen Database

• Elisa Eiseman
• 2006 NORD Annual Conference
• September 30, 2006
• This presentation is based on RAND Corporation
  research and authors opinions. Portions of this
  presentation describe work-in-progress that has
  not undergone RAND quality assurance procedures

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Human Biospecimens Defined

• Cells and subcellular structures (DNA, mRNA,
  protein)
• Blood and components (serum, plasma)
• Tissue (muscle, connective, epithelium, nerve)
• Organs (liver, bladder, heart, kidney)
• Gametes (sperm and ova), embryos, fetal tissue
• Waste (hair and nail clippings, urine, feces,
  sweat, shed skin cells, placenta)

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Use of Human Biospecimens in Research

• Human biospecimens have been stored for more than
  100 years in the United States
• Vast majority of biospecimens were originally
  collected for diagnostic or therapeutic reasons
• Biospecimens have played a major role in the
  understanding and treatment of a number of
  diseases
• New genomic and proteomic techniques increase the
  utility of biospecimens for discovering new ways
  to improve health

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RAND Studies of Human Biorepositories and
Biospecimens
1999
2003
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Human Biospecimen Collections

• gt 307 million specimens stored in the United
  States
• Accumulating at a rate of gt 20 million per year
• Range from formal repositories to informal
  collections by researchers
• Range in size from lt 200 to gt 92 million
  specimens
• Tissue available for research purposes
• Tissues originally collected for diagnostic or
  therapeutic reasons
• Tissue collected specifically for research
  purposes
• Tissue collected for other purposes
• (e.g., blood transfusions, organ
  transplantation, procreative purposes)

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Human Biospecimen Database

• Goal
• To facilitate research leading to treatments
  and cures for rare diseases, as well as more
  common diseases, by improving researchers' access
  to needed human biospecimens
• Objectives
• Create a publicly available, searchable,
  Web-based database of biorepositories
• Facilitate researchers' access to human
  biospecimens by creating a system that provides
  access to information about repositories and
  their collections.
• Identify unmet needs of researchers in obtaining
  human biospecimens for research on rare diseases.
  
• Provide information to researchers, the wider
  research community and other interested parties
  about biorepositories and biospecimens

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Information in the Database

• General information about each biorepository
• Number and type(s) of biospecimens stored at each
  repository
• Processing methods (e.g., paraffin blocks,
  slides, snap frozen)
• Storage conditions (e.g., room temperature,
  frozen in liquid nitrogen) and length of storage
• Type(s) of associated clinical information
• Limitations associated with the use of
  biospecimens
• Costs of obtaining biospecimens

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Case Studies of Existing Repositories

• Each repository is established to fulfill a
  specific set of objectives, and the design of
  each repository is integrally linked to those
  objectives
• Nationally agreed-upon quality control and
  standard operating procedures for the collection
  and storage of tissue are needed
• Older repositories are valuable because of
  magnitude of their collections and wealth of
  associated information

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Effects of Preanalytical Variables on the Quality
of Biospecimens

• Conduct a comprehensive search of the scientific
  literature to determine the effects of
  preanalytical variables on the quality of
  biospecimens
• Review procedures for clinical laboratory testing
  for data on such effects

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Preanalytical Variables

• Pre-acquisition variables
• Antibiotics
• Type of anesthesia
• Duration of anesthesia
• Arterial clamp time
• Blood pressure variations
• Intra-op blood loss
• Intra-op blood administration
• Intra-op fluid administration

• Post-acquisition variables
• Time at room temperature
• Temperature of room
• Type of fixative
• Time in fixative
• Rate of freezing
• Size of aliquots
• Storage temperature
• Storage duration

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Next Steps

• Human Biospecimen Database
• Complete pilot test and send out Data Collection
  Web site to all U.S. biorepositories
• Invite international biorepositories to
  participate
• Develop educational modules
• Effects of Preanalytical Variables on
  Biospecimens
• Analyze scientific literature and clinical
  laboratory testing procedures for effects of
  preanalytical variables
• Develop web-based forum for biospecimen
  researchers to find and contribute data, methods,
  other relevant information

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