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 24 条

[1]

Administration UDoHaHSFaD, 2018, FOOD DRUG ADM SAF IN

[2]

Administration UDoHaHSFaD. Pediatric Exclusivity Study Age Group, 2014, US

[3] Promoting Pediatric Drug Research and Labeling - Outcomes of Legislation [J].

Bourgeois, Florence T. ;

Kesselheim, Aaron S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (09) :875-881

[4]

Children and Clinical Studies, 2022, WHY CLIN STUD AR IMP

[5] Empirical Evaluation of Age Groups and Age-Subgroup Analyses in Pediatric Randomized Trials and Pediatric Meta-analyses [J].

Contopoulos-Ioannidis, Despina G. ;

Seto, Iva ;

Hamm, Michele P. ;

Thomson, Denise ;

Hartling, Lisa ;

Ioannidis, John P. A. ;

Curtis, Sarah ;

Constantin, Evelyn ;

Batmanabane, Gitanjali ;

Klassen, Terry ;

Williams, Katrina .

PEDIATRICS, 2012, 129 :S161-S184

[6]

[Field MJ. 4. Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Board on Health Sciences Policy Institute of Medicine 4. Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) Board on Health Sciences Policy Institute of Medicine], 2012, SAFE EFFECTIVE MED C

[7] Real-World Evidence for Assessing Treatment Effectiveness and Safety in Pediatric Populations [J].

Horton, Daniel B. ;

Blum, Michael D. ;

Burcu, Mehmet .

JOURNAL OF PEDIATRICS, 2021, 238 :312-316

[8] Large Databases for Pediatric Research on Children with Autism Spectrum Disorder [J].

Kuhlthau, Karen A. ;

Bailey, L. Charles ;

Baer, Briella L. ;

Coury, Daniel L. ;

Law, Kiely ;

Murray, Donna S. ;

Razzaghi, Hanieh ;

Forrest, Christopher B. ;

Lipkin, Paul H. .

JOURNAL OF DEVELOPMENTAL AND BEHAVIORAL PEDIATRICS, 2018, 39 (02) :168-176

[9] Real-World Evidence to Assess Medication Safety or Effectiveness in Children: Systematic Review [J].

Lasky, Tamar ;

Carleton, Bruce ;

Horton, Daniel B. ;

Kelly, Lauren E. ;

Bennett, Dimitri ;

Czaja, Angela S. ;

Gifkins, Dina ;

Osokogu, Osemeke U. ;

McMahon, Ann W. .

DRUGS-REAL WORLD OUTCOMES, 2020, 7 (02) :97-107

[10] In the Real-World, Kids Use Medications and Devices [J].

Tamar Lasky .

Drugs - Real World Outcomes, 2017, 4 (2) :75-78

← 1 2 3 →