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  • 1. Paula Kim , TRAC- T ranslating R esearch A cross C ommunities BBMRI Stakeholder’s Forum Patient Working Group Meeting Paris, France • December 15, 2009 Biobanking and Patients : A USA Perspective
  • 2. The Art of Translation…
    • “ From the standpoint of medicine as an art for the preparation and cure of disease, the man who translates the hieroglyphics of science into the plain language of healing is certainly more useful.”
    • -Sir William Osler, Physician
  • 3. Physical Behavioral Social Cultural Economic Political Spiritual Technological Across the Scientific and Geographic Spectrum
  • 4. Who is in the Biospecimen Sandbox?
    • Professional Societies
    • Researchers
    • Clinical Trial PI
    • Community MDs
    • Academic Center MDs and PhDs
    • Pathologists
    • Nurses and Allied Health
    • Professionals
    Research and Medical PKI © 2008 All Rights Reserved Personalized Medicine Biobank
    • Patients
    • Caregivers
    • Public
    • Organizations
    Advocacy
    • NCI
    • FDA, EMEA etc.
    • Funders
    • Regulators
    • Industry
    • Consortiums
    P&P Agencies and Industry
  • 5. Understanding Choices In Order To Make Decisions: What Patients Want Source: TRAC Perspectives on Costs of Cancer Care Survey-2006
    • Would any of following services provided by trained professional staff be of value when making decisions and understanding your choices:
      • Understand the potential risk or benefit of the treatment 85.7% (96/112)
      • Understand what is involved with the treatment itself 85.8% (97/113)
  • 6.
    • No coordinated system to assist patients
    • Why is clinical research and biospecimen participation like hide and seek?
    • Need “everyday” banking protocols for research and non-research use
    • Advocacy groups are taking matters into their own hands
    Hide and Seek?
  • 7. Ethical Consideration: Are we making the most of specimens donated by patients?
    • Too many years of discussion on single use versus tiered consents… need universal action plan
    • This impasse impedes progress!
    • Patients want to have confidence in knowing their specimens are appropriately SHARED FOR REAL
      • Tiered consent forms are one part of a workable solution
    • We need to put this problem behind us!
  • 8. ANNALS OF NEUROLOGY SEPTEMBER 2007 Which Way Is The Wind Blowing?
  • 9. Legal and Regulatory Considerations: Incentives, reimbursement, custodianship, patient demands, market size, IP, technical obstacles, scientific serendipity… Which of these has the greatest influence on development and use of high impact biomarker assays in clinical settings ? Which is not fixable?
  • 10. Not One Size FitsAll
    • Public
    • Private
    • Population
      • Cohorts
    • Disease Based
      • Pathology
        • Diagnosis, prognosis
      • Research Specimens
  • 11.
    • Objectives:
    • Unify policies and procedures for biospecimen resources supported by the NCI or used by NCI-supported investigators
    • Based on State of the Science as defined by 3 years of due diligence
    National Cancer Institute Best Practices Source: National Cancer Institute OBBR
  • 12.
    • Includes recommendations and guidelines for:
    • Operational best practices for research biorepositories
    • Quality assurance and quality control programs
    • Establishing reporting mechanisms
    • Providing administration and management structure
    • Ethical, legal, and policy issues
    • Informed consent
    • Access to specimens and data
    • Privacy protection – HIPAA
    • Ownership of specimens
    • Intellectual property
    National Cancer Institute Best Practices Source: National Cancer Institute OBBR
  • 13. Biospecimen Boogie No One Likes to Dance Alone & How Not To Step On Toes…
    • Patient Advocacy groups are a resource
    • Create relationships for win-win
    • More Advocacy Groups are Biobankers
    • Teamwork Needed to Deal With Issues
    • Double Standards Not Acceptable
  • 14.
    • “ We must harness the scientific, industrial, and social will to accelerate discoveries into accessible and meaningful clinical applications. Patients, families, friends, and loved one are counting on us…Because in the end, it’s not about you, or me, or the science, it’s about the patient.”
    • Paula Kim - Research & Patient Advocate
    Why We Must Get This Right…
  • 15. Patient & Advocate Perspectives Don’t Leave Home Without Them Info on Biospecimen Resources: www.tracnetwork.net