Real world data (RWD) in pediatrics

被引：4

作者：

Lasky, Tamar ^{[1
,2
]}

Chakravarty, Aloka ^{[1
]}

机构：

[1] US FDA, Off Data Analyt & Res, Silver Spring, MD USA

[2] US FDA, Off Data Analyt & Res, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA

来源：

JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2023年 / 33卷 / 06期

关键词：

Pediatrics; real-world data; SAFETY; DATABASES; CHILDREN;

D O I：

10.1080/10543406.2022.2152834

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Unique challenges pertain when studying children, although many research principles are the same as those when studying adult populations. This truism extends to the use of real-world data (RWD). RWD are particularly relevant to pediatrics because they may potentially provide an additional source of data to inform pediatric labeling and practice patterns when clinical trials have not been or cannot be conducted. The purpose of this commentary is to provide a brief overview of the unique issues in using RWD to study the effectiveness or safety of medical therapies in children.

引用

页码：875 / 880

页数：6

共 50 条

[1] REAL WORLD DATA (RWD) AT T=4 IN THE NETHERLANDS
Lie, X.
Nijhuis, T.
VALUE IN HEALTH, 2014, 17 (07) : A422 - A422
[2] Use of Real World Data (RWD) to generate Real World Evidence (RWE) in gynecologic surgery
Rudnicki, Martin
ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA, 2021, 100 (12) : 2133 - 2134
[3] The utility of data tokenization for real world data (RWD) access in clinical trials
Petraro, Paul
Heywood, Carla
Niyonkuru, Christian
Zhang, Ling
Gilliam, Devin
Cummins, Gordon
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2022, 31 : 551 - 551
[4] ONCOLOGY REAL WORLD DATA (RWD): ENABLING LEARNING HEALTH SYSTEMS
Arondekar, B.
Zlateva, G.
Levy, J. A.
Wiinberg, L.
Woolmore, A. L.
VALUE IN HEALTH, 2019, 22 : S538 - S539
[5] Real world evidence, outcome research and healthcare management improvement through real world data (RWD)
Varela-Rodriguez, Carolina
Rosillo-Ramirez, Nicolas
Rubio-Valladolid, Gabriel
Ruiz-Lopez, Pedro
FRONTIERS IN PUBLIC HEALTH, 2023, 10
[6] The study on TAVR Medical Twin Method Based on Real World Data(RWD)
Hyun, Se-Min
Lee, KangYoon
2023 INTERNATIONAL CONFERENCE ON INFORMATION NETWORKING, ICOIN, 2023, : 678 - 682
[7] DEVELOPMENT OF REAL-WORLD DATA AND THE USE OF RWD FOR EVIDENCE GENERATION IN CHINA
Cai, B.
Xie, Y.
Gong, Y.
Luo, W.
Qu, H.
Liu, J.
VALUE IN HEALTH, 2019, 22 : S389 - S390
[8] EXPERIENCE IN IMPLEMENTING CLINICAL TRIAL TO REAL-WORLD DATA (RWD) LINKAGE
NajafZadeh, M.
Saunders, D.
Demirci, S.
Niamathullah, S.
Vaccaro, T.
McConnochie, B.
Polewaczyk, J.
Tyagi, A.
Ahmed, A.
Oromendia, A.
VALUE IN HEALTH, 2024, 27 (06) : S393 - S393
[9] Incorporating external real-world data (RWD) in confirmatory adaptive design
Lin, Junjing
Lin, Jianchang
JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2024, 34 (06) : 805 - 817
[10] Gender Differences in CKD Progression: Real-World Data (RWD) Analysis
Stavas, Joseph
Filler, Guido
Irwin, Debra E.
Lovett, Kate
Shah, Rohan J.
Butler, Emily L.
Ferris, Maria E.
JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2022, 33 (11): : 573 - 573

← 1 2 3 4 5 →