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：
“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
下载
收藏
页码：18 / 20
页数：3
相关论文
共 50 条
  • [1] The value of patient-reported outcomes in early-phase clinical trials
    Ameeta Retzer
    Olalekan Lee Aiyegbusi
    Anna Rowe
    Philip N. Newsome
    Jessica Douglas-Pugh
    Sheeba Khan
    Saloni Mittal
    Roger Wilson
    Daniel O’Connor
    Lisa Campbell
    Sandra A. Mitchell
    Melanie Calvert
    Nature Medicine, 2022, 28 : 18 - 20
  • [2] Incorporation of patient-reported outcomes in early-phase clinical trials for childhood and adolescent cancer
    Vilaplana, Andrea
    Morell, Mariona
    Valero-Arrese, Lorena
    Marshall, Lynley V.
    Salo, Anna
    Crowe, Tracey
    Romero, Laura
    de Rojas, Teresa
    Carceller, Fernando
    Moreno, Lucas
    PEDIATRIC BLOOD & CANCER, 2024, 71 (09)
  • [3] Comment on: Incorporation of patient-reported outcomes in early-phase clinical trials for childhood and adolescent cancer
    Revon-Riviere, Gabriel
    Connolly, Denise
    Cohen-Gogo, Sarah
    PEDIATRIC BLOOD & CANCER, 2024,
  • [4] Development and implementation of a systematic approach to measure patient-reported outcomes in early-phase cancer trials
    King, Amanda L.
    Levine, Jason E.
    Vera, Elizabeth
    Gandhi, Yuti
    Novakovich, Elaine
    Yu, Theresa
    Berhanu, Sefanit
    Locke, Ciara
    Julmeus, Kaelyn
    Mendoza, Tito
    Armstrong, Terri S.
    CANCER RESEARCH, 2024, 84 (06)
  • [5] Patient-Reported Outcomes and Clinical Trials
    Althof, Stanley E.
    JOURNAL OF SEXUAL MEDICINE, 2016, 13 (07): : 1027 - 1028
  • [6] Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials
    Huey, Ryan W.
    George, Goldy C.
    Phillips, Penny
    White, Revenda
    Fu, Siqing
    Janku, Filip
    Karp, Daniel D.
    Naing, Aung
    Piha-Paul, Sarina
    Subbiah, Vivek
    Tsimberidou, Apostolia M.
    Pant, Shubham
    Yap, Timothy A.
    Rodon, Jordi
    Meric-Bernstam, Funda
    Shih, Ya-Chen Tina
    Hong, David S.
    ONCOLOGIST, 2021, 26 (07): : 588 - 596
  • [7] Using Patient-Reported Outcomes (PROs) in Early-Phase Dose-finding Oncology Trials (EDOT): a global survey
    Lai-Kwon, Julia
    Vanderbeek, Alyssa
    Minchom, Anna
    Yap, Christina
    QUALITY OF LIFE RESEARCH, 2021, 30 (SUPPL 1) : S23 - S23
  • [8] Patient-reported outcomes in asthma clinical trials
    Braido, Fulvio
    Baiardini, Ilaria
    Canonica, Giorgio W.
    CURRENT OPINION IN PULMONARY MEDICINE, 2018, 24 (01) : 70 - 77
  • [9] PATIENT-REPORTED OUTCOMES IN RANDOMIZED CLINICAL TRIALS
    Shoulson, I.
    MUSCLE & NERVE, 2014, 50 : S2 - S2
  • [10] REVIEW OF PATIENT-REPORTED OUTCOMES IN PHASE II ONCOLOGY CLINICAL TRIALS
    Finnern, H. W.
    Danheiser, S.
    Barkalow, F.
    ANNALS OF ONCOLOGY, 2010, 21 : 183 - 183
12345