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FACULTY |
Edward S. Kim, MD – Chair
Assistant Professor of Medicine
The University of Texas
MD Anderson Cancer Center
Houston, Texas
David Cella, PhD
Chair, Department of Medical Social Services
Northwestern University Feinberg School of Medicine
Professor of Psychiatry and Behavioral Science
Research Professor, Institute for Healthcare Studies
Cancer Control Program Leader
Robert H. Lurie Comprehensive Cancer Center
Northwestern University
Chicago, Illinois
Richard J. Gralla, MD
Vice President for Cancer Services
North Shore-LIJ Health System
Lake Success, New York
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Karen Kelly, MD
Deputy Director, University of Kansas Cancer Center
Frank B Tyler, Professor
University of Kansas Medical Center
Kansas City, Kansas
Fadlo R. Khuri, MD
Roberto C. Goizueta Distinguished Professor and Chair
Department of Hematology and Medical Oncology
Deputy Director for Clinical and Translational Research
Emory University
Winship Cancer Institute
Atlanta, Georgia
J. Jack Lee, PhD, DDS
Professor of Biostatistics
Department of Biostatistics
Division of Quantitative Sciences
The University of Texas
MD Anderson Cancer Center
Houston, Texas
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FEATURED CONTENT |
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Welcome and Introduction to Lung Cancer Efficacy Endpoints |
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Stable Disease and Disease Control Rate: Useful Endpoints in Lung Cancer? |
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Nuclear Imaging in Efficacy Assessment of Lung Cancer Therapy |
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Using Quality of Life Tools in Lung Cancer Clinical Trials |
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Selecting and Evaluating Efficacy Endpoints for Lung Cancer Trials:
What the Investigator and Clinician Should Know About the Statistics |
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Integrating Lung Cancer Trial Results Into Clinical Practice |
This activity is sponsored by
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This activity is supported by educational grants from
Genentech BioOncology and OSI Oncology |
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| MEDIA: WEBCAST |
Estimated time to complete activity: 2.0 hours | Release Date: August 10, 2009 | Expiration Date: August 9, 2010
This activity may be accessed at www.educationalconcepts.net. |
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| STATEMENT OF NEED |
Clinical trial endpoints that are selected by investigators and the results that are obtained after the
conduct of a study are the backbone of evidence-based medicine in any field. A major challenge
the oncology community faces is the definition and determination of the meaningful primary and
secondary endpoints for clinical trials. Standardization of definitions for efficacy endpoints is needed to
increase the consistency of trial conduct and outcome reporting. Inconsistencies confound the analysis,
interpretation, and application of trial results by investigators, clinicians, regulatory agencies, sponsors,
and patients. There have been recent reports that may make endpoints that have been more secondary
in nature, such as disease control rate, quality of life, and functional scanning of tumors, move to the
forefront. Recognizing the complexity of today’s treatment decisions, this initiative has been developed
to provide a forum for the interactive exchange of ideas and data. Our analysis of the science and
evidence-based treatment approaches for the management of lung cancer, specifically the examination
of clinical trial endpoints, constitutes a need in the continuing education of oncology healthcare
professionals. An educational program that engages learners to identify specific learning needs and
integrate new information has been designed to improve patient outcomes.
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LEARNING OBJECTIVES
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Explain traditional efficacy endpoints that have been used in clinical trials designed to evaluate treatment of patients with lung cancer, including survival and response rate |
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Evaluate the utility of surrogate endpoints in the assessment of efficacy of new treatments in lung cancer including functional imaging, stable disease rate, and disease control rate |
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Describe the advantages and limitations of quality of life endpoints that have been used in clinical trials in lung cancer |
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Integrate results of key studies in lung cancer into patient care decisions, including those data that are contradictory or paradoxical to other data within the same study or data from similar studies |
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| TARGET AUDIENCE |
The target audience for this educational initiative is medical oncologists, surgical oncologists, radiation oncologists, pathologists, and all other healthcare professionals managing patients with lung cancer. |
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PHYSICIAN CONTINUING EDUCATION
Accreditation Statement
Educational Concepts Group, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Designation of Credit
Educational Concepts Group, LLC designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
| PHARMACIST CONTINUING EDUCATION |
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Educational Concepts Group, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. |
Educational Concepts Group, LLC designates this continuing education activity for
2 contact hours (0.2 CEUs). (UPN 199-000-09-032-H01-P).
METHOD OF PARTICIPATION
There are no fees for participating and receiving CME/CE credit for this activity. During the period August 10, 2009 through August 9, 2010, participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the post-test. Participants must view each section in its entirety to receive full credit for this program.
Physicians and pharmacists who complete the post-test with a score of 70% or better may view and print their credit certificates via the website, www.educationalconcepts.net.
ACKNOWLEDGEMENT OF COMMERCIAL SUPPORT
This activity is supported by educational grants from Genentech BioOncology and
OSI Oncology.
DISCLAIMER
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Please refer to the official prescribing information for each product or consult the Physicians’ Desk Reference for discussion of approved indications, contraindications,
and warnings.
None of the contents may be reproduced in any form without prior written permission from the publisher. This activity may be accessed at www.educationalconcepts.net. |
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ECG has declared the following financial relationships:
ECG receives educational grants from pharmaceutical industry and other commercial sources. Planners, managers, and other staff members at ECG have no relevant financial relationships to disclose.
FACULTY DISCLOSURE STATEMENT
All faculty participating in continuing education activities sponsored by ECG are expected to disclose to the audience any real or apparent commercial financial affiliations related to the content of their presentations/materials.
The following faculty members have declared relevant financial relationships:
Edward S. Kim, MD - Chair
Grants/Research Support
Eli Lilly and Company, Genentech BioOncology, ImClone Systems, sanofi-aventis Group
Consultant Fees
Eli Lilly and Company, Genentech BioOncology, ImClone Systems, sanofi-aventis Group
David Cella, PhD
No relationships to disclose
Richard J. Gralla, MD
Grants/Research Support
sanofi-aventis Group
Consultant Fees
GlaxoSmithKline, Merck & Co., Inc., sanofi-aventis Group
Honorarium
Merck & Co., Inc., sanofi-aventis Group
Karen Kelly, MD
Consultant Fees
Eli Lilly and Company
Fadlo R. Khuri, MD
Grants/Research Support
Novartis
Consultant Fees
ImClone Systems, sanofi-aventis Group, Tragara Pharmaceuticals, Inc.
Speakers' Bureau
sanofi-aventis Group
J. Jack Lee, PhD, DDS
No relationships to disclose
CME/CE INQUIRIES
For further information, please contact:
Educational Concepts Group, LLC
1300 Parkwood Circle SE, Suite 325
Atlanta, Georgia 30339
Phone: 1.770.933.1681
Fax: 1.770.933.1692
www.educationalconcepts.net
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