The value of patient-reported outcomes in early-phase clinical trials

被引：31

作者：

Retzer, Ameeta ^{[1
,2
]}

Aiyegbusi, Olalekan Lee ^{[1
,2
,3
,4
]}

Rowe, Anna ^{[3
,5
]}

Newsome, Philip N. ^{[3
,6
]}

Douglas-Pugh, Jessica ^{[5
]}

Khan, Sheeba ^{[3
,6
,7
]}

Mittal, Saloni ^{[8
]}

Wilson, Roger ^{[9
]}

O'Connor, Daniel ^{[10
]}

Campbell, Lisa ^{[10
]}

Mitchell, Sandra A. ^{[11
]}

Calvert, Melanie ^{[1
,2
,3
,4
,12
,13
]}

机构：

[1] Univ Birmingham, Inst Appl Hlth Res, Ctr Patient Reported Outcomes Res, Birmingham, W Midlands, England

[2] Univ Birmingham, Appl Res Ctr West Midlands, Natl Inst Hlth Res, Birmingham, W Midlands, England

[3] Univ Hosp Birmingham NHS Fdn Trust, Birmingham Biomed Res Ctr, Natl Inst Hlth Res, Birmingham, W Midlands, England

[4] Birmingham Hlth Partners Ctr Regulatory Sci & Inn, Birmingham, W Midlands, England

[5] Univ Birmingham, Canc Res UK Clin Trials Unit, Birmingham, W Midlands, England

[6] Univ Birmingham, Inst Immunol & Immunotherapy, Ctr Liver & Gastrointestinal Res, Birmingham, W Midlands, England

[7] Univ Hosp Birmingham NHS Fdn Trust, Liver Unit, Birmingham, W Midlands, England

[8] Univ Birmingham, Birmingham, W Midlands, England

[9] NCRI Consumer Forum Natl Canc Res Inst, London, England

[10] Med & Healthcare Prod Regulatory Agcy MHRA, London, England

[11] NIH, Outcomes Res Branch, Div Canc Control & Populat Sci, Rockville, MD USA

[12] Univ Birmingham, Surg Reconstruct & Microbiol Res Ctr, Natl Inst Hlth Res, Birmingham, W Midlands, England

[13] Univ Birmingham, UK SPINE, Birmingham, W Midlands, England

来源：

NATURE MEDICINE | 2022年 / 28卷 / 01期

基金：

“创新英国”项目; 英国科研创新办公室;

关键词：

VALIDITY;

D O I：

10.1038/s41591-021-01648-4

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

If used correctly, patient-reported outcomes can provide preliminary evidence of efficacy and tolerability from a patient perspective, as well as supporting regulatory review.

引用

页码：18 / 20

页数：3

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