Cancer Clinical Trials: Proactive Strategies

1. Historical Perspective and Evolving Concerns for Human Research
Bernard Lo, Nesrin Garan

2. Cancer Trials and the Institutional Review Board (IRB)
Scott Kurtzman, Zita Lazzarini

3. NCI’s Cancer Therapy Evaluation Program: A Commitment to Treatment Trials
Jeffrey S. Abrams, Anthony Murgo, Michaele C. Christian

4. The Role of the FDA in Cancer Clinical Trials
Steven Hirschfeld

5. The Role of Cooperative Groups in Cancer Clinical Trials
Ann M. Mauer, Elizabeth S. Rich, Richard L. Schilsky

6. The Advocate Role in Clinical Study Development and Partnering with Patient Advocates in Your Local Institution
Barbara Parker

7. The National Breast Cancer Coalition: Setting the Standard for Advocate Collaboration in Clinical Trials
Fran Visco

8. The Role of the Principal Investigator in Cancer Clinical Trials
Stanley P. L. Leong

9. The Audit Process and How to Ensure a Successful Audit
Y. Nancy You, Lisa Jacobs, Elizabeth Martinez, David M. Ota

10. The Privacy Rule (HIPAA) as it Relates to Clinical Research
John M. Harrelson, John M. Falletta

11. The Commission on Cancer, American College of Surgeons’ Response to HIPAA
E. Greer Gay

12. Ethical and Legal Issues in the Conduct of Cancer Clinical Trials
Gerianne J. Sands, Peggy A. Means

13. The Role of the Office of Research Integrity in Cancer Clinical Trials
Peter Abbrecht, Nancy Davidian, Samuel Merrill, Alan R. Price

14. Strategies for the Administration of a Clinical Trials Infrastructure: Lessons from a Comprehensive Cancer Center
Leonard A. Zwelling, Carleen A. Brunelli

15. The Clinical Research Process: Building a System in Harmony with its Users
Greg Koski

16. Cancer Research and Clinical Trial in Action: An Important Exercise Before You Embark on Your Study
Larry Carbone, Scott H. Kurtzman, Stanley P. L. Leong

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Keywords: MEDICAL / Public Health MED078000