TY - JOUR
T1 - Patient-reported outcomes assessment in cancer trials
T2 - Taking stock, moving forward
AU - Lipscomb, Joseph
AU - Reeve, Bryce B.
AU - Clauser, Steven B.
AU - Abrams, Jeffrey S.
AU - Bruner, Deborah Watkins
AU - Burke, Laurie B.
AU - Denicoff, Andrea M.
AU - Ganz, Patricia A.
AU - Gondek, Kathleen
AU - Minasian, Lori M.
AU - O'Mara, Ann M.
AU - Revicki, Dennis A.
AU - Rock, Edwin P.
AU - Rowland, Julia H.
AU - Sgambati, Maria
AU - Trimble, Edward L.
PY - 2007/11/10
Y1 - 2007/11/10
N2 - To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.
AB - To evaluate and improve the use of cancer trial end points that reflect the patient's own perspective, the National Cancer Institute organized an international conference, Patient-Reported Outcomes Assessment in Cancer Trials (PROACT), in 2006. The 13 preceding articles in this special issue of the Journal were commissioned in preparation for or in response to the PROACT conference, which was cosponsored by the American Cancer Society. Drawing from these articles and also commentary from the conference itself, this concluding report takes stock of what has been learned to date about the successes and challenges in patient-reported outcome (PRO) assessment in phase III, phase II, and symptom management trials in cancer and identifies ways to improve the scientific soundness, feasibility, and policy relevance of PROs in trials. Building on this synthesis of lessons learned, this article discusses specific administrative policies and management procedures to improve PRO data collection, analysis, and dissemination of findings; opportunities afforded by recent methodologic and technologic advances in PRO data collection and analysis to enhance the scientific soundness and cost efficiency of PRO use in trials; and the importance of better understanding the usefulness of PRO data to the full spectrum of cancer decision makers, including patients and families, health providers, public and private payers, regulatory agencies, and standards-setting organizations.
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U2 - 10.1200/JCO.2007.12.4644
DO - 10.1200/JCO.2007.12.4644
M3 - Article
C2 - 17991933
AN - SCOPUS:36849021996
SN - 0732-183X
VL - 25
SP - 5133
EP - 5140
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 32
ER -