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.

Clinical trials remain the most important vehicle for improving the care of cancer patients. This text presents the fundamental components and challenges involving clinical investigations. Leading experts discuss the critical issues covering the spectrum of important topics from planning to application.