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Book part
Publication date: 1 November 2007

Sarah Rosenbloom, Susan Yount, Kathleen Yost, Debra Hampton, Diane Paul, Amy Abernethy, Paul B. Jacobsen, Karen Syrjala, Jamie Von Roenn and David Cella

Recent guidance from the United States Food and Drug Administration discusses patient-reported outcomes as endpoints in clinical trials (FDA, 2006). Using methods consistent with…

Abstract

Recent guidance from the United States Food and Drug Administration discusses patient-reported outcomes as endpoints in clinical trials (FDA, 2006). Using methods consistent with this guidance, we developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from National Comprehensive Cancer Network (NCCN) member institutions and four non-profit social service organizations. Diagnoses included the following 11 primary cancers: bladder, brain, breast, colorectal, head/neck, hepatobiliary/pancreatic, kidney, lung, lymphoma, ovarian and prostate. Physician experts in each of 11 diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results were evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also at NCCN institutions (Cella et al., 2003). The final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

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The Value of Innovation: Impact on Health, Life Quality, Safety, and Regulatory Research
Type: Book
ISBN: 978-1-84950-551-2

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Book part
Publication date: 1 November 2007

Abstract

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The Value of Innovation: Impact on Health, Life Quality, Safety, and Regulatory Research
Type: Book
ISBN: 978-1-84950-551-2

Book part
Publication date: 18 April 2002

J. Stuart Bunderson and Kathleen M. Sutcliffe

Why are some management teams more strongly oriented toward learning than others? The dominant notion in the learning literature is that teams will seek to learn when their…

Abstract

Why are some management teams more strongly oriented toward learning than others? The dominant notion in the learning literature is that teams will seek to learn when their outcomes do not live up to their aspirations. In this paper we argue that this perspective overlooks important factors in the social context of a management team that can promote or inhibit an orientation toward learning. In-depth analysis of qualitative and quantitative data obtained from four business unit management teams in a Fortune 100 consumer products company supports this thesis. Specifically, we find that a teams learning orientation is fostered by: (1) an emphasis on ends over means combined with clarity around ends, (2) team norms that tolerate mistakes of commission but sanction mistakes of omission, (3) a sense of uniqueness combined with a strong sense of team efficacy, and (4) cross-boundary interaction facilitated by experientially-broad boundary spanners. These findings both confirm as well as extend theoretical and empirical work on the factors that activate learning and innovation.

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Toward Phenomenology of Groups and Group Membership
Type: Book
ISBN: 978-1-84950-144-6

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