1 results
Invited Paper D Industry perspective regarding outcomes research in oncology
-
- By Kati Copley-Merriman, M.S., M.B.A., Senior Director/Site Leader Pfizer Inc., Joseph Jackson, Ph.D., Group Director Bristol-Myers Squibb, J. Gregory Boyer, Ph.D., Assistant Executive Director Pharmacia Corp, Joseph C. Cappelleri, Ph.D., Director, Biostatistics Pfizer Inc., Robert DeMarinis, Ph.D., Assistant Vice President Wyeth-Ayerst Research, Joseph DiCesare, M.P.H., R.Ph., Executive Director Novartis Pharmaceuticals Corp., M. Haim Erder, Ph.D., Director Amgen Inc., Jean Paul Gagnon, Ph.D., Director Aventis Pharmaceuticals Inc., Lou Garrison, Ph.D., Vice President and Head F. Hoffman-La Roche AG, Kathleen Gondek, Ph.D., Director Bayer Corp., Kim A. Heithoff, Ph.D., Director Schering-Plough Pharmaceuticals, Tom Hughes, Ph.D., Director Eli Lilly and Company, David Miller, Ph.D., Vice President GlaxoSmithKline, Margaret Rothman, Ph.D., Executive Director Johnson & Johnson Pharmaceutical Services, LLC, Nancy Santanello, M.D., M.S., Executive Director Merck Research Laboratories, Richard Willke, Ph.D., Senior Director/Group Leader Pharmacia Corp, Bruce Wong, M.D., Vice President Bristol-Myers Squibb
- Edited by Joseph Lipscomb, National Cancer Institute, Bethesda, Maryland, Carolyn C. Gotay, Claire Snyder, National Cancer Institute, Bethesda, Maryland
-
- Book:
- Outcomes Assessment in Cancer
- Published online:
- 18 December 2009
- Print publication:
- 23 December 2004, pp 623-638
-
- Chapter
- Export citation
-
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.