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