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

被引：27
|
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：
英国科研创新办公室; “创新英国”项目;
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
收藏
页码：18 / 20
页数：3
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