Biospecimens: Challenges and Solutions in Cancer Research

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Biospecimens Challenges and Solutions in Cancer
Research
J. Milburn Jessup, M.D., FACS Chief, Diagnostics
Evaluation Branch Cancer Diagnosis Program On
Behalf of Carolyn Compton, M.D., Ph.D. Director,
Office of Biorepositories and Biospecimen
Research
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Overview

• Why are specimens important ?
• Barriers to patient participation
• Barriers to physician participation
• What the researcher needs to help patients
• NCI aids

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Personalized Therapeutics the future of
healthcare

• doctors will eventually be able to analyze a
  patients genetic profile and prescribe the best
  available medicine. (FDA, 2005)
• NIH-funded research has found specific
  differences that can predict whether certain
  cancer drugs will be toxic to a patient. (NIH,
  2005)
• Personalized medicine will be predictive,
  preventive, personalized, and participatory. It
  will make billions of measurements on each
  individual and new computational and
  mathematical techniques will be required for
  analysis. (Lee Hood, Institute for Systems
  Biology)

Vanderbilt University Medical Center by Balser
et al. 2006
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Personalized Medicine Personalized Care
Butwill require that each patient provide
specimens for analysis
http//www.bdbioscience.com/
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Its all about the sample
What are the barriers for Patients? Physicians? Re
searchers?
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Concerns of Patients Are Being Addressed by NORD

• Why havent they cured cancer?
• Not aware of the shortage of high-quality
  specimens for research
• Whats a clinical trial and why should I be on
  one?
• Not aware of process of by which medical advances
  are validated
• Not aware of benefits of trial participation
• Whats a biospecimen?
• Not aware how tissue removed at surgery or other
  biopsies are processed for clinical care or
  research and how they might differ
• Not aware that the excess tissue from their
  cancer surgery will be discarded after pathologic
  diagnosis is performed

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Specific Concerns of Patients About Tissue
Donation

• Is there a benefit for me if I donate tissue or
  other specimens?
• Will I get better care?
• Will I be paid?
• Will I have legal rights to profits from products
  developed from use of my tissues?
• Is there risk for me?
• Will it cost me anything in time, money,
  hospitalization, etc?
• Will I get worse care?
• Will they take out more tissue than they would
  otherwise?
• Will someone be selling my tissues for profit?
• Will my privacy be protected?
• Can I change my mind about donating tissue?

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General Impediments

• Failure to communicate value and requirements of
  trial
• Inadequate tissue for both diagnosis and banking
• Lack of personnel, limited pathologist time
• Departmental, hospital or state rules (or
  perceived rules) precluding participation
• Liability concerns
• Pathologist uncertainty about what is required
• Inadequate monetary support
• Special requirements not familiar, feasible or
  communicated in trial protocol
• Forms not user friendly

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Researchers Perspective

• Why is it so hard to get these specimens?
• How do I get access to these specimens?
• Why is IRB approval so lengthy and complex?
• Lack of harmonization of ethical, legal and
  policy issues governing use of biospecimens at
  governmental agency level (OHRP, FDA, OHRP, OCR
  HIPAA) causes confusion and conservative
  behavior
• Do I have to pay for these?
• Why is the quality so bad?
• Is there a reliable source?

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Its all about the sample
Science Requires Quality Otherwise
Garbage In ? Garbage Out
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What do we need to succeed?

• Collect, bank, mine, and study a massive number
  of genetic profiles linked to rich sets of
  clinical outcome data
• Development of ultra-large clinical genomic
  datasets requires healthcare information
  technology that is searchable, scalable, and
  shareable
• Capability to analyze ultra-large datasets across
  centers

Vanderbilt University Medical Center by Balser
et al. 2006
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Solutions on the Way

• Common biorepository SOPs and management
  principles
• Common definitions and vocabulary
• Common computerized access to data on specimens
• Common approaches to ethical, legal and policy
  issues

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NCI First Generation Guidelines Outline Standards
for Biorepositories

• Specimen collection, processing, storage,
  retrieval, and dissemination
• Collecting and managing clinical data
• Quality assurance, quality control
• Biorepository informatics data management,
  inventory control, tracking
• Ethics, Legal Policy consent, privacy,
  custodianship, access, intellectual property

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Advance patient focused research by fostering
interactions among advocates, researchers, and
organizations Research Advocacy Network
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Biospecimens Challenges and Solutions in Cancer
Research
J. Milburn Jessup, M.D., FACS Chief, Diagnostics
Evaluation Branch Cancer Diagnosis
Program (301)-435-9010 jessupj_at_mail.nih.gov