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A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms (1999)
Institute of Medicine (IOM)

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. "Front Matter." A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington, DC: The National Academies Press, 1999.

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

Contents

   

SUMMARY

  

1
   

INTRODUCTION

  

4
   

ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS

  

5
   

CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS

  

6
   

The Two Prongs of Clinical Trial Protocol Review and Monitoring,

  

6
   

The National Cancer Institute,

  

7
   

Department of Veterans Affairs,

  

11
   

INSTITUTIONAL REVIEW BOARDS

  

13
   

THE FOOD AND DRUG ADMINISTRATION

  

16
   

The Commercial IND Application,

  

16
   

Noncommercial INDs,

  

17
   

Protection of Human Subjects,

  

18
   

COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA

  

18
   

Reviews for Scientific Merit,

  

18
   

Reviews and Procedures to Ensure the Safety and Rights of Participants,

  

19
   

REFERENCES

  

19
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