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Introduction

Introduction Over the past 30 years, National Cancer Institute (NCI) has supported quality of life (QOL) assessments in conjunction with its clinical trials and convened periodic workshops to review the progress of its inclusion as an endpoint (1,2). In 2003, the NCI staff initiated a systematic review of health-related quality of life (HRQL) assessments in the symptom management clinical trials conducted through the Community Clinical Oncology Program (CCOP). The review evaluated whether assessing QOL contributed additional value to the results of the trials beyond the effect of the intervention on the designated symptom (3). In practice, a clinician would treat a patient's symptoms even if the successful resolution of those symptoms did not result in an improvement in the patient's overall QOL (4). The CCOP program is an NCI-funded clinical trials network and the primary mechanism to support NCI-sponsored symptom management clinical trials. From 1995 through 2005, more than 100 of these types of clinical trials were conducted. Almost all are randomized, placebo-controlled clinical trials with an assessment of the designated symptom as the primary endpoint. HRQL assessments have been encouraged as a means to further describe the patient's experience in conjunction with his/her cancer treatment. The typical endpoints in cancer treatment clinical trials have been survival, response to therapy, risk of recurrence, and toxicities. These endpoints include both objective measures and physician-reported endpoints. For clinical trials that are designed as toxicity reduction studies, the typical primary endpoint has been a reduction from a high to a lower grade of toxicity, as measured by the Common Terminology Criteria for Adverse Events (CTCAE, formerly Common Toxicity Criteria). For example, a study to evaluate an agent hypothesized to mitigate radiation-induced dermatitis would look at the reduction in grade 3 or higher skin toxicity as evaluated by CTCAE (5). However, not all toxicities are amenable to CTCAE, which is a clinician-based reporting tool. For subjective or symptomatic toxicities, the CTCAE might not accurately reflect the patient's perception of that toxicity or its burden (6). Thus, it becomes important to capture the patient's own assessment of improvement in these symptoms. With a more precise assessment of the specific symptom, is it possible to also capture a sense of the impact of the symptom on the patient's overall HRQL? During the process of reviewing the assessment tools being used for the primary and secondary endpoints in the symptom management trials, several key issues emerged (3). Investigators did not routinely describe their underlying rationale for including HRQL assessments as secondary endpoints nor delineate the hypothesized relationship between the improvement of a symptom and a subsequent improved QOL. Finally, it became clear that the specific questions asked in the assessment tools may not always address the concerns or the issues that the investigators are most interested in exploring. For example, FACT-N, a seven-item instrument assessment tool to measure peripheral neuropathy, has one question specific to ringing in the ears (7). Although this is an important question to help capture cisplatin-induced neuropathy, it may not be relevant in the neuropathies that develop with some of the newer targeted agents. Thus, using this specific tool may not be the most suitable for capturing the patients' perceptions of neuropathy with some of the newer agents. One of the recommendations from the NCI review was to convene a workshop that would explore the role of assessing QOL of patients enrolled on the symptom management clinical trials done through the NCI CCOP program. Convened on October 24–25, 2005, the workshop focused on three areas: 1) the rationale for QOL inclusion in symptom management trials, 2) the conceptual framework for the QOL assessment, and 3) the instruments, measurements, and analysis. The workshop included HRQL investigators within the CCOP program, HRQL investigators funded by NCI but not involved in the CCOP program, and NCI and Food and Drug Administration (FDA) colleagues. The FDA was invited to provide the regulatory perspective of incorporating QOL or patient-reported outcomes into symptom management trials. Additionally, the FDA was soon to release a draft guidance for the role of patient reported outcomes in the drug approval process (8). As patients live longer both as cancer patients and as cancer survivors, there is a growing need to manage both short-term side effects and long-term sequelae of treatment. It becomes important to design and develop clinical trials in a manner that will provide useful information to physicians and patients. This monograph provides more fully developed versions of the papers that were presented at the workshop and a summary conclusion by Drs Ganz and Goodwin. The goal is to highlight critical issues to advance the state of the science in future research on HRQL assessment in cancer symptom management clinical trials. Assessing Quality of Life (QOL) in Cancer Symptom Management Trials Workshop Participants List Claudia Aguado, MPH Research Coordinator Pediatrics Epidemiology Center Community Clinical Oncology Program H. Lee Moffitt Cancer Center at the University of South Florida Tampa, FL Noreen Aziz, MD, PhD, MPH Senior Program Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Andrea Barsevick, DNSc, RN, AOCN Director of Nursing Research Department of Population Science Fox Chase Cancer Center Cheltenham, PA Peter Bross, MD Clinical Team Leader Division of Clinical Evaluation Center for Biologics Evaluation and Research Food and Drug Administration Rockville, MD David Buchanan, DrPH Research Fellow Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Robert Croyle, PhD Director Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Andrea Denicoff, RN, MS, ANP Nurse Consultant Clinical Investigations Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute National Institutes of Health Bethesda, MD Michelle DeSilvio, PhD Senior Biostatistician Department of Statistics American College of Radiology Philadelphia, PA Raymond Dionne, PhD, DDS Scientific Director National Institute of Nursing Research National Institutes of Health Bethesda, MD Molla Donaldson, DrPH Senior Scientist Quality of Care Research and Policy Outcomes Research Branch Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Amylou Dueck, PhD Research Associate Division of Biostatistics Mayo Clinic College of Medicine Rochester, MN Sara Dapen, PhD Research Associate Department of Biostatistics and Computational Biology Eastern Cooperative Oncology Group Statistical Center Dana-Farber Cancer Institute Boston, MA Ann Farrell, MD Clinical Team Leader Division of Drug Oncology Products Food and Drug Administration Rockville, MD Michael Fisch, MD, MPH Medical Director Community Clinical Oncology Program The University of Texas M. D. Anderson Cancer Center Houston, TX Carolyn Gotay, PhD Professor, Program Director Prevention and Control Program Cancer Research Center of Hawaii Honolulu, HI Martha Hare, PhD, RN Program Director National Institute of Nursing Research National Institutes of Health Bethesda, MD Pamela Hinds, PhD, RN Director Division of Nursing Research St. Jude's Children's Research Hospital Memphis, TN Joseph Kelaghan, MD Program Director Community Oncology and Prevention Trials Research Group National Cancer Institute National Institutes of Health Bethesda, MD Alice Kornblith, PhD Senior Research Scientist Department of Medical Oncology Women's Cancer Program Dana-Farber Cancer Institute Boston, MA Virginia Kwitowski, MS, RN, CRNP Senior Nurse Practitioner Medical Oncology Branch Center for Cancer Research National Cancer Institute National Institutes of Health Bethesda, MD Joseph Lipscomb, PhD Professor of Public Health Health Policy and Management Rollins School of Public Health Emory University Atlanta, GA Susan Marden, PhD Clinical Nurse Scientist National Institute of Nursing Research National Institutes of Health Bethesda, MD Lori Minasian, MD Chief Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Gary Morrow, PhD, MS Professor of Radiation Oncology Professor of Psychiatry James P. Wilmot Cancer Center University of Rochester Medical Center Rochester, NY Michelle Naughton, PhD Associate Professor Section on Social Sciences and Health Policy Department of Public Health Sciences School of Medicine Wake Forest University Winston-Salem, NC Ann O'Mara, PhD, RN Program Director Community Clinical Oncology Program Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD J. Lynn Palmer, PhD Associate Professor of Biostatistics Palliative Care and Rehabilitation Medicine The University of Texas M. D. Anderson Cancer Center Houston, TX Bryce Reeve, PhD Psychometrician Outcomes Research Branch Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Ellen Richmond, RN, MS, GNP Nurse Specialist (Clinical Trials) Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Julia Rowland, PhD Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Jane Scott, PhD Endpoint Reviewer Study Endpoint and Development Team Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, MD Maria Sgambati, MD Program Director Community Oncology Program Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Bonnie Teschendorf, PhD Director Quality of Life Science Cancer Control and Population Science American Cancer Society Atlanta, GA Ted Trimble, MD, MPH Head Quality of Cancer Care Therapeutics Clinical Investigations Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute Bethesda, MD Lynne Wagner, PhD Clinical Research Scientist The Center on Outcomes, Research and Education Evanston Northwestern Healthcare Northwestern University Medical School Chicago, IL Lari Wenzel, PhD Associate Professor General Internal Medicine University of California, Irvine Irvine, CA Linda Wong Extramural Support Assistant Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD References (1) Nayfield SG , Hailey BJ , McCabe M . Quality of life assessment in cancer clinical trials Report of the Workshop on Quality of Life Research in Cancer Clinical Trials; July 16–17, 1990; Bethesda (MD):US DHHS; 1991 (2) Varricchio CG , McCabe MS , Trimble E , Korn EL . Quality of life in clinical cancer trials , J Natl Cancer Inst Monogr , 1996 , vol. 20 (pg. vii - viii ) OpenURL Placeholder Text WorldCat (3) Buchanan DR , O'Mara AM , Kelaghan JW , Minasian LM . Quality-of-life assessment in the symptom management trials of the National Cancer Institute-supported Community Clinical Oncology Program , J Clin Oncol , 2005 , vol. 23 (pg. 591 - 8 ) Google Scholar Crossref Search ADS PubMed WorldCat (4) Jatoi A , Kumar S , Sloan JA , Nguyen PL . On appetite and its loss , J Clin Oncol , 2000 , vol. 18 (pg. 2930 - 2 ) Google Scholar PubMed OpenURL Placeholder Text WorldCat (5) Elliot EA , Wright JR , Swann RS , Nguyen-Tân F , Takita C , Bucci MK , et al. Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13 , J Clin Oncol , 2006 , vol. 24 (pg. 2092 - 7 ) Google Scholar Crossref Search ADS PubMed WorldCat (6) Basch E , Iasonos A , McDonough T , Barz A , Culkin A , Kris MG , et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study , Lancet Oncol , 2006 , vol. 7 (pg. 903 - 9 ) Google Scholar Crossref Search ADS PubMed WorldCat (7) Calhoun EA , Welshman EE , Chang CH , Lurain JR , Fishman DA , Hunt TL , et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy , Int J Gynecol Cancer , 2003 , vol. 13 (pg. 741 - 8 ) Google Scholar Crossref Search ADS PubMed WorldCat (8) Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims Available at: http://www.fda.gov/cder/guidance/5460dft.htm. [Last accessed: March 23, 2007.] " Workshop entitled “Assessing Quality of Life (QOL) in Cancer Symptom Management Trials” was supported by the Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Published by Oxford University Press 2007. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JNCI Monographs Oxford University Press

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References (8)

Publisher
Oxford University Press
Copyright
Published by Oxford University Press 2007.
ISSN
1052-6773
eISSN
1745-6614
DOI
10.1093/jncimonographs/lgm001
Publisher site
See Article on Publisher Site

Abstract

Over the past 30 years, National Cancer Institute (NCI) has supported quality of life (QOL) assessments in conjunction with its clinical trials and convened periodic workshops to review the progress of its inclusion as an endpoint (1,2). In 2003, the NCI staff initiated a systematic review of health-related quality of life (HRQL) assessments in the symptom management clinical trials conducted through the Community Clinical Oncology Program (CCOP). The review evaluated whether assessing QOL contributed additional value to the results of the trials beyond the effect of the intervention on the designated symptom (3). In practice, a clinician would treat a patient's symptoms even if the successful resolution of those symptoms did not result in an improvement in the patient's overall QOL (4). The CCOP program is an NCI-funded clinical trials network and the primary mechanism to support NCI-sponsored symptom management clinical trials. From 1995 through 2005, more than 100 of these types of clinical trials were conducted. Almost all are randomized, placebo-controlled clinical trials with an assessment of the designated symptom as the primary endpoint. HRQL assessments have been encouraged as a means to further describe the patient's experience in conjunction with his/her cancer treatment. The typical endpoints in cancer treatment clinical trials have been survival, response to therapy, risk of recurrence, and toxicities. These endpoints include both objective measures and physician-reported endpoints. For clinical trials that are designed as toxicity reduction studies, the typical primary endpoint has been a reduction from a high to a lower grade of toxicity, as measured by the Common Terminology Criteria for Adverse Events (CTCAE, formerly Common Toxicity Criteria). For example, a study to evaluate an agent hypothesized to mitigate radiation-induced dermatitis would look at the reduction in grade 3 or higher skin toxicity as evaluated by CTCAE (5). However, not all toxicities are amenable to CTCAE, which is a clinician-based reporting tool. For subjective or symptomatic toxicities, the CTCAE might not accurately reflect the patient's perception of that toxicity or its burden (6). Thus, it becomes important to capture the patient's own assessment of improvement in these symptoms. With a more precise assessment of the specific symptom, is it possible to also capture a sense of the impact of the symptom on the patient's overall HRQL? During the process of reviewing the assessment tools being used for the primary and secondary endpoints in the symptom management trials, several key issues emerged (3). Investigators did not routinely describe their underlying rationale for including HRQL assessments as secondary endpoints nor delineate the hypothesized relationship between the improvement of a symptom and a subsequent improved QOL. Finally, it became clear that the specific questions asked in the assessment tools may not always address the concerns or the issues that the investigators are most interested in exploring. For example, FACT-N, a seven-item instrument assessment tool to measure peripheral neuropathy, has one question specific to ringing in the ears (7). Although this is an important question to help capture cisplatin-induced neuropathy, it may not be relevant in the neuropathies that develop with some of the newer targeted agents. Thus, using this specific tool may not be the most suitable for capturing the patients' perceptions of neuropathy with some of the newer agents. One of the recommendations from the NCI review was to convene a workshop that would explore the role of assessing QOL of patients enrolled on the symptom management clinical trials done through the NCI CCOP program. Convened on October 24–25, 2005, the workshop focused on three areas: 1) the rationale for QOL inclusion in symptom management trials, 2) the conceptual framework for the QOL assessment, and 3) the instruments, measurements, and analysis. The workshop included HRQL investigators within the CCOP program, HRQL investigators funded by NCI but not involved in the CCOP program, and NCI and Food and Drug Administration (FDA) colleagues. The FDA was invited to provide the regulatory perspective of incorporating QOL or patient-reported outcomes into symptom management trials. Additionally, the FDA was soon to release a draft guidance for the role of patient reported outcomes in the drug approval process (8). As patients live longer both as cancer patients and as cancer survivors, there is a growing need to manage both short-term side effects and long-term sequelae of treatment. It becomes important to design and develop clinical trials in a manner that will provide useful information to physicians and patients. This monograph provides more fully developed versions of the papers that were presented at the workshop and a summary conclusion by Drs Ganz and Goodwin. The goal is to highlight critical issues to advance the state of the science in future research on HRQL assessment in cancer symptom management clinical trials. Assessing Quality of Life (QOL) in Cancer Symptom Management Trials Workshop Participants List Claudia Aguado, MPH Research Coordinator Pediatrics Epidemiology Center Community Clinical Oncology Program H. Lee Moffitt Cancer Center at the University of South Florida Tampa, FL Noreen Aziz, MD, PhD, MPH Senior Program Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Andrea Barsevick, DNSc, RN, AOCN Director of Nursing Research Department of Population Science Fox Chase Cancer Center Cheltenham, PA Peter Bross, MD Clinical Team Leader Division of Clinical Evaluation Center for Biologics Evaluation and Research Food and Drug Administration Rockville, MD David Buchanan, DrPH Research Fellow Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Robert Croyle, PhD Director Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Andrea Denicoff, RN, MS, ANP Nurse Consultant Clinical Investigations Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute National Institutes of Health Bethesda, MD Michelle DeSilvio, PhD Senior Biostatistician Department of Statistics American College of Radiology Philadelphia, PA Raymond Dionne, PhD, DDS Scientific Director National Institute of Nursing Research National Institutes of Health Bethesda, MD Molla Donaldson, DrPH Senior Scientist Quality of Care Research and Policy Outcomes Research Branch Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Amylou Dueck, PhD Research Associate Division of Biostatistics Mayo Clinic College of Medicine Rochester, MN Sara Dapen, PhD Research Associate Department of Biostatistics and Computational Biology Eastern Cooperative Oncology Group Statistical Center Dana-Farber Cancer Institute Boston, MA Ann Farrell, MD Clinical Team Leader Division of Drug Oncology Products Food and Drug Administration Rockville, MD Michael Fisch, MD, MPH Medical Director Community Clinical Oncology Program The University of Texas M. D. Anderson Cancer Center Houston, TX Carolyn Gotay, PhD Professor, Program Director Prevention and Control Program Cancer Research Center of Hawaii Honolulu, HI Martha Hare, PhD, RN Program Director National Institute of Nursing Research National Institutes of Health Bethesda, MD Pamela Hinds, PhD, RN Director Division of Nursing Research St. Jude's Children's Research Hospital Memphis, TN Joseph Kelaghan, MD Program Director Community Oncology and Prevention Trials Research Group National Cancer Institute National Institutes of Health Bethesda, MD Alice Kornblith, PhD Senior Research Scientist Department of Medical Oncology Women's Cancer Program Dana-Farber Cancer Institute Boston, MA Virginia Kwitowski, MS, RN, CRNP Senior Nurse Practitioner Medical Oncology Branch Center for Cancer Research National Cancer Institute National Institutes of Health Bethesda, MD Joseph Lipscomb, PhD Professor of Public Health Health Policy and Management Rollins School of Public Health Emory University Atlanta, GA Susan Marden, PhD Clinical Nurse Scientist National Institute of Nursing Research National Institutes of Health Bethesda, MD Lori Minasian, MD Chief Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Gary Morrow, PhD, MS Professor of Radiation Oncology Professor of Psychiatry James P. Wilmot Cancer Center University of Rochester Medical Center Rochester, NY Michelle Naughton, PhD Associate Professor Section on Social Sciences and Health Policy Department of Public Health Sciences School of Medicine Wake Forest University Winston-Salem, NC Ann O'Mara, PhD, RN Program Director Community Clinical Oncology Program Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD J. Lynn Palmer, PhD Associate Professor of Biostatistics Palliative Care and Rehabilitation Medicine The University of Texas M. D. Anderson Cancer Center Houston, TX Bryce Reeve, PhD Psychometrician Outcomes Research Branch Applied Research Program Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Ellen Richmond, RN, MS, GNP Nurse Specialist (Clinical Trials) Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Julia Rowland, PhD Director Office of Cancer Survivorship Division of Cancer Control and Population Sciences National Cancer Institute National Institutes of Health Bethesda, MD Jane Scott, PhD Endpoint Reviewer Study Endpoint and Development Team Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring, MD Maria Sgambati, MD Program Director Community Oncology Program Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD Bonnie Teschendorf, PhD Director Quality of Life Science Cancer Control and Population Science American Cancer Society Atlanta, GA Ted Trimble, MD, MPH Head Quality of Cancer Care Therapeutics Clinical Investigations Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute Bethesda, MD Lynne Wagner, PhD Clinical Research Scientist The Center on Outcomes, Research and Education Evanston Northwestern Healthcare Northwestern University Medical School Chicago, IL Lari Wenzel, PhD Associate Professor General Internal Medicine University of California, Irvine Irvine, CA Linda Wong Extramural Support Assistant Community Oncology and Prevention Trials Research Group Division of Cancer Prevention National Cancer Institute National Institutes of Health Bethesda, MD References (1) Nayfield SG , Hailey BJ , McCabe M . Quality of life assessment in cancer clinical trials Report of the Workshop on Quality of Life Research in Cancer Clinical Trials; July 16–17, 1990; Bethesda (MD):US DHHS; 1991 (2) Varricchio CG , McCabe MS , Trimble E , Korn EL . Quality of life in clinical cancer trials , J Natl Cancer Inst Monogr , 1996 , vol. 20 (pg. vii - viii ) OpenURL Placeholder Text WorldCat (3) Buchanan DR , O'Mara AM , Kelaghan JW , Minasian LM . Quality-of-life assessment in the symptom management trials of the National Cancer Institute-supported Community Clinical Oncology Program , J Clin Oncol , 2005 , vol. 23 (pg. 591 - 8 ) Google Scholar Crossref Search ADS PubMed WorldCat (4) Jatoi A , Kumar S , Sloan JA , Nguyen PL . On appetite and its loss , J Clin Oncol , 2000 , vol. 18 (pg. 2930 - 2 ) Google Scholar PubMed OpenURL Placeholder Text WorldCat (5) Elliot EA , Wright JR , Swann RS , Nguyen-Tân F , Takita C , Bucci MK , et al. Phase III trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13 , J Clin Oncol , 2006 , vol. 24 (pg. 2092 - 7 ) Google Scholar Crossref Search ADS PubMed WorldCat (6) Basch E , Iasonos A , McDonough T , Barz A , Culkin A , Kris MG , et al. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study , Lancet Oncol , 2006 , vol. 7 (pg. 903 - 9 ) Google Scholar Crossref Search ADS PubMed WorldCat (7) Calhoun EA , Welshman EE , Chang CH , Lurain JR , Fishman DA , Hunt TL , et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy , Int J Gynecol Cancer , 2003 , vol. 13 (pg. 741 - 8 ) Google Scholar Crossref Search ADS PubMed WorldCat (8) Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims Available at: http://www.fda.gov/cder/guidance/5460dft.htm. [Last accessed: March 23, 2007.] " Workshop entitled “Assessing Quality of Life (QOL) in Cancer Symptom Management Trials” was supported by the Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services. Published by Oxford University Press 2007.

Journal

JNCI MonographsOxford University Press

Published: Oct 1, 2007

There are no references for this article.