Cancer Clinical Trials: Proactive Strategies

Hardcover | May 14, 2007

EditorStanley P. L. Leong

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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. The book has a foreword by Samuel A. Wells, Jr., MD, Professor of Surgery, Duke University Medical Center, Durham, NC, former Director of the American College of Surgeons and Founder of the American College of Surgeons Oncology Group.

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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. The book has a foreword by Samue...

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Foreword written by Samuel A. Wells, Jr., MDProfessor of SurgeryDuke University Medical Center, Durham, NCAccording to the American Cancer Society, about 1 million persons in the United States will be diagnosed with solid cancer every year. About 50% of them will be potentially cured by surgery. The other half of the population may dev...

Format:HardcoverDimensions:338 pages, 9.25 × 6.14 × 0.27 inPublished:May 14, 2007Publisher:Springer USLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0387332243

ISBN - 13:9780387332246

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Table of Contents

Preface.- Foreword.- 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 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 and Responsibility 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 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.- Conclusion.- Index.