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.

By:

Gelband, Hellen

Contributor(s):

National Cancer Policy Board (U.S.)

Material type: Text

TextPublication details: Washington D.C. : National Research Council, 1999.Description: 1 online resourceContent type:

text

Media type:

computer

Carrier type:

online resource

ISBN:

0309583012
9780309583015

Subject(s): Genre/Form:

DDC classification:

614.59990973 22

LOC classification:

RC276 .G45 1999eb

NLM classification:

QZ 266

Online resources:

Click here to access online

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""

Abstract: 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.

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Title from caption (viewed June 14, 2001).

"February 1999."

Includes bibliographical references.

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.

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