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A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms / Hellen Gelband ; prepared for the National Cancer Policy Board.
- Format:
- Book
- Author/Creator:
- Gelband, Hellen.
- Language:
- English
- Subjects (All):
- Cancer--Treatment.
- Cancer.
- Oncology--Research.
- Oncology.
- Clinical trials.
- Physical Description:
- 1 online resource (25 p.)
- Place of Publication:
- Washington D.C. : National Research Council, 1999.
- Language Note:
- English
- Summary:
- This report for the National Cancer Policy Board (NCPB) describes the procedures currently in place in the United States for approving and monitoring clinical trials of cancer treatments. Virtually all cancer clinical trials are funded by agencies of the federal government or the pharmaceutical industry, so the focus is on the requirements for each of these groups. The paper is intended as a jumping off point for the NCPB to consider some of the pressing policy issues surrounding clinical trials in cancer, though as yet, no specific follow-on projects have been initiated.
- Contents:
- ""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""
- Notes:
- "February 1999."
- Includes bibliographical references.
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