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Implementing a national cancer clinical trials system for the 21st century : workshop summary /
an American Society of Clinical Oncology and Institute of Medicine Workshop ; Alison Mack and Sharyl J. Nass, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies.
imprint
Washington, D.C. : National Academies Press, c2011.
description
xiii, 108 p. : ill. ; 23 cm.
ISBN
0309212685, 9780309212687
format(s)
Book
Holdings
More Details
imprint
Washington, D.C. : National Academies Press, c2011.
isbn
0309212685
9780309212687
contents note
Panel I : NCI and the cooperative groups -- Panel II : Payors -- Panel III : Interactions between industry, the FDA, and the publicly funded cancer clinical trials system -- Panel IV : Clinical trials investigators and patient advocates.
catalogue key
8319459
 
Also available online.
Includes bibliographical references (p. 91-93).
A Look Inside
Summaries
Description for Bookstore
Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Centuryoutlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.
Long Description
Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.
Table of Contents
Introductionp. 1
NCI and the Cooperative Groupsp. 4
NCI Perspective and Current Activitiesp. 4
Overview of the NCI Responsep. 4
Response of the NCI Community Clinical Oncology Program (CCOP)p. 19
Cooperative Group Leadership Perspective and Current Activitiesp. 22
Cooperative Group Chairs' Perspectivep. 22
Group Statisticians' Perspectivep. 26
Experience from the Consolidation of the Children's Oncology Group (COG)p. 27
Panel Discussionp. 30
Consolidation of Cooperative Groupsp. 30
Encouraging Collaborationp. 32
Reducing NCI Oversight of the Cooperative Groupsp. 34
Going Forwardp. 36
Payorsp. 36
Payor Policiesp. 37
An Insurer's Perspectivep. 37
Kaiser Permanente's Dual Rolep. 39
Medicare and Medicaid Support of Clinical Trialsp. 40
Demonstrating Utility to Payorsp. 40
Analysis of Cancer Clinical Trials Coveragep. 42
Coverage of Phase I Trialsp. 44
Determining the Standard of Carep. 48
Establishing New Common Procedural Terminology (CPT) Codes for Care of Patients Enrolled in Clinical Trialsp. 48
Interactions Between Industry, the FDA, and the Publicly Funded Cancer Clinical Trials Systemp. 50
Pharmaceutical Industry Perspectivep. 51
Diagnostic Industry Perspectivep. 52
FDA Perspectivep. 54
Central IRB and Informed Consentp. 57
Partnerships Between Industry and the Cooperative Groupsp. 59
Informaticsp. 64
Vendor Perspectivep. 64
Completeness Versus Flexibilityp. 66
Clinical Trials Investigators and Patient Advocatesp. 69
Clinical Trials Investigatorsp. 69
CCOP Physician Perspectivep. 69
Academic Clinical Investigator Perspectivep. 74
Community Cancer Center Perspectivep. 76
Patient Advocatesp. 78
Cooperative Group Patient Advocate Perspectivep. 78
Research Foundation Perspectivep. 80
Panel Discussionp. 81
Maintaining Engagement of Cooperative Group Investigatorsp. 81
Measuring Successp. 82
Open Trial Enrollmentp. 84
Selection of Trial Sitesp. 85
Funding Clinical Trialsp. 86
Closing Remarksp. 87
Referencesp. 91
Acronymsp. 95
Appendixes
Workshop Agendap. 99
Executive Summary of A National Cancer Clinical Trials System for the 21st Centuryp. 105
Boxes, Tables, and Figures
Summary of the IOM Consensus Recommendationsp. 3
Timeline for Implementing a New Funding Opportunity Announcement for the Cooperative Group Programp. 14
NCCN Categories of Evidence and Consensusp. 38
CCOP Strategic Goals, 2010p. 71
Progress by NCI Toward Goals and Recommendations of the IOM Report A National Cancer Clinical Trials System for the 21st Century (2010)p. 6
Overall Cooperative Group Funding Structure, Fiscal Year 2007p. 24
Rates of Approval for Coverage of Care in a Cancer Clinical Trial, by Insurance Provider, at Johns Hopkins University Hospital, from July 2003 to July 2008p. 45
NCI's proposed new organizational structure for the Cooperative Group Programp. 17
States with laws mandating clinical trials coveragep. 44
Distribution of the 63 CCOP and Minority CCOP sites across the United States and in Puerto Rico, as of June 2010p. 71
Table of Contents provided by Ingram. All Rights Reserved.

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