Outcomes and endpoints in cancer trials: bridging the divide

被引：70

作者：

Wilson, Michelle K. ^{[1
]}

Collyar, Deborah ^{[2
]}

Chingos, Diana T. ^{[3
]}

Friedlander, Michael ^{[4
]}

Ho, Tony W. ^{[5
]}

Karakasis, Katherine ^{[1
]}

Kaye, Stan ^{[6
,7
,8
]}

Parmar, Mahesh K. B. ^{[9
]}

Sydes, Matthew R. ^{[9
]}

Tannock, Ian F. ^{[1
]}

Oza, Amit M. ^{[1
]}

机构：

[1] Univ Toronto, Princess Margaret Canc Ctr, Toronto, ON M5G 2M9, Canada

[2] Patient Advocates Res, Danville, CA USA

[3] Noreen Fraser Fdn, Los Angeles, CA USA

[4] Univ New S Wales, Prince Wales Clin Sch, Sydney, NSW, Australia

[5] AstraZeneca, Wilmington, DE 19850 USA

[6] Royal Marsden Hosp, Drug Dev Unit, London SW3 6JJ, England

[7] Royal Marsden Hosp, Gynaecol Unit, London SW3 6JJ, England

[8] Inst Canc Res, London SW3 6JB, England

[9] UCL, MRC, Clin Trials Unit, London, England

来源：

LANCET ONCOLOGY | 2015年 / 16卷 / 01期

关键词：

POSITRON-EMISSION-TOMOGRAPHY; PATIENT-REPORTED OUTCOMES; QUALITY-OF-LIFE; RANDOMIZED CONTROLLED-TRIALS; METASTATIC PROSTATE-CANCER; CELL LUNG-CANCER; CLINICAL-TRIALS; BREAST-CANCER; COLORECTAL-CANCER; OVARIAN-CANCER;

D O I：

10.1016/S1470-2045(14)70380-8

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Cancer is not one disease. Outcomes and endpoints in trials should incorporate the therapeutic modality and cancer type because these factors affect clinician and patient expectations. In this Review, we discuss how to: define the importance of endpoints; make endpoints understandable to patients; improve the use of patient-reported outcomes; advance endpoints to parallel changes in trial design and therapeutic interventions; and integrate these improvements into trials and practice. Endpoints need to reflect benefit to patients, and show that changes in tumour size either in absolute terms (response and progression) or relative to control (progression) are clinically relevant. Improvements in trial design should be accompanied by improvements in available endpoints. Stakeholders need to come together to determine the best approach for research that ensures accountability and optimises the use of available resources.

引用

页码：E43 / E52

页数：10

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