A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms

A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms Copyright Preface Report Reviewers Contents SUMMARY Cancer Treatment Trial Sponsors Quality Standards for Cancer Treatment Trials Common Elements of Clinical Trial Review Criteria Reviews for Scientific Merit Reviews and Procedures to Ensure the Safety and Rights of Participants INTRODUCTION ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS The Two Prongs of Clinical Trial Protocol Review and Monitoring The National Cancer Institute The Cancer Therapy Evaluation Program The Cancer Centers Program Department of Veterans Affairs The Cooperative Studies Program VA-Funded Research at Single VA Medical Centers INSTITUTIONAL REVIEW BOARDS THE FOOD AND DRUG ADMINISTRATION The Commercial IND Application Noncommercial INDs Protection of Human Subjects COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA Reviews for Scientific Merit Reviews and Procedures to Ensure the Safety and Rights of Participants REFERENCES