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Invited Paper D Industry perspective regarding outcomes research in oncology

Published online by Cambridge University Press:  18 December 2009

By
Kati Copley-Merriman M.S., M.B.A. ,
Joseph Jackson Ph.D. ,
J. Gregory Boyer Ph.D. ,
Joseph C. Cappelleri Ph.D. ,
Robert DeMarinis Ph.D. ,
Joseph DiCesare M.P.H., R.Ph. ,
M. Haim Erder Ph.D. ,
Jean Paul Gagnon Ph.D. ,
Lou Garrison Ph.D.  and
Kathleen Gondek Ph.D.
...Show all authors
Edited by
Joseph Lipscomb ,
Carolyn C. Gotay  and
Claire Snyder
Kati Copley-Merriman M.S., M.B.A.
Affiliation:
Senior Director/Site Leader Pfizer Inc.
Joseph Jackson Ph.D.
Affiliation:
Group Director Bristol-Myers Squibb
J. Gregory Boyer Ph.D.
Affiliation:
Assistant Executive Director Pharmacia Corp
Joseph C. Cappelleri Ph.D.
Affiliation:
Director, Biostatistics Pfizer Inc.
Robert DeMarinis Ph.D.
Affiliation:
Assistant Vice President Wyeth-Ayerst Research
Joseph DiCesare M.P.H., R.Ph.
Affiliation:
Executive Director Novartis Pharmaceuticals Corp.
M. Haim Erder Ph.D.
Affiliation:
Director Amgen Inc.
Jean Paul Gagnon Ph.D.
Affiliation:
Director Aventis Pharmaceuticals Inc.
Lou Garrison Ph.D.
Affiliation:
Vice President and Head F. Hoffman-La Roche AG
Kathleen Gondek Ph.D.
Affiliation:
Director Bayer Corp.
Kim A. Heithoff Ph.D.
Affiliation:
Director Schering-Plough Pharmaceuticals
Tom Hughes Ph.D.
Affiliation:
Director Eli Lilly and Company
David Miller Ph.D.
Affiliation:
Vice President GlaxoSmithKline
Margaret Rothman Ph.D.
Affiliation:
Executive Director Johnson & Johnson Pharmaceutical Services, LLC
Nancy Santanello M.D., M.S.
Affiliation:
Executive Director Merck Research Laboratories
Richard Willke Ph.D.
Affiliation:
Senior Director/Group Leader Pharmacia Corp
Bruce Wong M.D.
Affiliation:
Vice President Bristol-Myers Squibb
Joseph Lipscomb
Affiliation:
National Cancer Institute, Bethesda, Maryland
Carolyn C. Gotay
Affiliation:
Cancer Research Center, Hawaii
Claire Snyder
Affiliation:
National Cancer Institute, Bethesda, Maryland
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Summary

Introduction

The goal of treatment for many persons with cancer is not cure but improvement or maintenance of functioning and well-being during their remaining period of life. This is particularly true for patients with advanced or metastatic cancers. Trials to produce evidence of effectiveness or for regulatory approval may include patient assessments of benefit as well as classical clinical endpoints used in oncology settings. These patient assessments of treatment benefit may or may not be related to the traditional measures of treatment success such as survival, tumor shrinkage, or time to tumor progression. For this reason, additional outcome measures to estimate benefit or risk/benefit trade-offs have been developed. Outcomes measures in this category of health assessment are referred to as patient-reported outcomes (PROs) because they are used to collect data directly from the patient.

It is increasingly recognized that the patient's perspective is unique and represents a valuable contribution to drug evaluation and treatment processes. This is particularly important when studying the effects of treatments on cancer symptoms such as pain and fatigue, outcomes not accurately measured by observers. Recent changes in the health care system have greatly empowered patients who are now considered partners rather than passive consumers. To maximize their contribution, they need to be informed about the outcomes associated with treatment. Patients are not always concerned with the same questions as treating physicians or clinical researchers.

Type
Chapter
Information
Outcomes Assessment in Cancer
Measures, Methods and Applications
 , pp. 623 - 638
Publisher: Cambridge University Press
Print publication year: 2004

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