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

共 50 条

[41] Trustworthiness of Patient-Reported Outcomes in Unblinded Cancer Clinical Trials
Atkinson, Thomas M.
Wagner, Jan-Samuel
Basch, Ethan
JAMA ONCOLOGY, 2017, 3 (06) : 738 - 739
[42] PATIENT-REPORTED OUTCOMES IN COMMERCIAL PEDIATRIC ONCOLOGY CLINICAL TRIALS
Murugappan, M.
King-Kallimanis, B. L.
Reaman, G. H.
Bhatnagar, V
Horodniceanu, E. G.
Bouchkouj, N.
Kluetz, P. G.
VALUE IN HEALTH, 2021, 24 : S59 - S59
[43] PATIENT-REPORTED OUTCOMES (PROS) IN OVARIAN CANCER CLINICAL TRIALS
Pease, S.
Barsdorf, A., I
VALUE IN HEALTH, 2015, 18 (03) : A210 - A210
[44] Integration of patient-reported outcomes in multiregional confirmatory clinical trials
Gnanasakthy, Ari
DeMuro, Carla
Boulton, Caroline
CONTEMPORARY CLINICAL TRIALS, 2013, 35 (01) : 62 - 69
[45] The prognostic significance of patient-reported outcomes in cancer clinical trials
Gotay, Carolyn C.
Kawamoto, Crissy T.
Bottomley, Andrew
Efficace, Fabio
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (08) : 1355 - 1363
[46] Patient-reported Outcomes (PROs) in clinical trials in paediatric dentistry
Gilchrist, Fiona
Marshman, Zoe
INTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, 2020, 31 : 31 - 37
[47] Standardizing patient-reported outcomes assessment in cancer clinical trials: A patient-reported outcomes measurement information system initiative
Garcia, Sofia F.
Cella, David
Clauser, Steven B.
Flynn, Kathryn E.
Lad, Thomas
Lai, Jin-Shei
Reeve, Bryce B.
Smith, Ashley Wilder
Stone, Arthur A.
Weinfurt, Kevin
JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (32) : 5106 - 5112
[48] Patient-Reported Outcomes in Cardiovascular Trials
Creber, Ruth Masterson
Spadaccio, Cristiano
Dimagli, Arnaldo
Myers, Annie
Taylor, Brittany
Fremes, Stephen
CANADIAN JOURNAL OF CARDIOLOGY, 2021, 37 (09) : 1340 - 1352
[49] Trends in patient -reported outcome (PRO) use in early-phase oncology trials
Lai-Kwon, Julia
Yin, Zhulin
Minchom, Anna
Yap, Christina
QUALITY OF LIFE RESEARCH, 2020, 29 (SUPPL 1) : S53 - S53
[50] The Value of Patient-Reported Outcomes in Single-Arm Cancer Trials
Di Maio, Massimo
CANCER INVESTIGATION, 2023, 41 (05) : 491 - 494

← 1 2 3 4 5 →