Cancer Clinical Trials: Proactive Strategies


ISBN: 978-0-387-33224-6 (Print) 978-0-387-33225-3 (Online)
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Table of contents (16 chapters)

  1. Front Matter

    Pages i-xix

  2. Book Chapter

    Pages 1-10

    Historical Perspective and Evolving Concerns for Human Research

  3. Book Chapter

    Pages 11-30

    Cancer Trials and the Institutional Review Board (IRB)

  4. Book Chapter

    Pages 31-50

    NCI’s Cancer Therapy Evaluation Program: A Commitment to Treatment Trials

  5. Book Chapter

    Pages 51-109

    The Role of the FDA in Cancer Clinical Trials

  6. Book Chapter

    Pages 111-129

    The Role of Cooperative Groups in Cancer Clinical Trials

  7. Book Chapter

    Pages 131-141

    The Advocate Role in Clinical Study Development and Partnering with Patient Advocates in Your Local Institution

  8. Book Chapter

    Pages 143-156

    The National Breast Cancer Coalition: Setting the Standard for Advocate Collaboration in Clinical Trials

  9. Book Chapter

    Pages 157-177

    The Role of the Principal Investigator in Cancer Clinical Trials

  10. Book Chapter

    Pages 179-197

    The Audit Process and How to Ensure a Successful Audit

  11. Book Chapter

    Pages 199-207

    The Privacy Rule (HIPAA) as it Relates to Clinical Research

  12. Book Chapter

    Pages 209-217

    The Commission on Cancer, American College of Surgeons’ Response to HIPAA

  13. Book Chapter

    Pages 219-229

    Ethical and Legal Issues in the Conduct of Cancer Clinical Trials

  14. Book Chapter

    Pages 231-239

    The Role of the Office of Research Integrity in Cancer Clinical Trials

  15. Book Chapter

    Pages 241-274

    Strategies for the Administration of a Clinical Trials Infrastructure: Lessons from a Comprehensive Cancer Center

  16. Book Chapter

    Pages 275-290

    The Clinical Research Process: Building a System in Harmony with its Users

  17. Book Chapter

    Pages 291-309

    Cancer Research and Clinical Trial in Action: An Important Exercise Before You Embark on Your Study

  18. Back Matter

    Pages 311-319