Cancer Clinical Trials: Proactive Strategies

Historical Perspective and Evolving Concerns for Human Research.- Cancer Trials and the Institutional Review Board (IRB).- NCI’s Cancer Therapy Evaluation Program: A Commitment to Treatment Trials.- The Role of the FDA in Cancer Clinical Trials.- The Role of Cooperative Groups in Cancer Clinical Trials.- The Advocate Role in Clinical Study Development and Partnering with Patient Advocates in Your Local Institution.- The National Breast Cancer Coalition: Setting the Standard for Advocate Collaboration in Clinical Trials.- The Role of the Principal Investigator in Cancer Clinical Trials.- The Audit Process and How to Ensure a Successful Audit.- The Privacy Rule (HIPAA) as it Relates to Clinical Research.- The Commission on Cancer, American College of Surgeons’ Response to HIPAA.- Ethical and Legal Issues in the Conduct of Cancer Clinical Trials.- The Role of the Office of Research Integrity in Cancer Clinical Trials.- Strategies for the Administration of a Clinical Trials Infrastructure: Lessons from a Comprehensive Cancer Center.- The Clinical Research Process: Building a System in Harmony with its Users.- Cancer Research and Clinical Trial in Action: An Important Exercise Before You Embark on Your Study.