Evidence map›Paper›PMID 37690792›Full record

ReviewPharmacoepidemiology and drug safety2024

Overview of global real-world data sources for pediatric pharmacoepidemiologic research.

Gerold T Wharton, Claudia Becker, Dimitri Bennett, Mehmet Burcu, Greta Bushnell, Carmen Ferrajolo, Sigal Kaplan, Ann W McMahon, Naimisha Movva, Sudha R Raman and 4 more

Open access · greenAbstract readReview
In one paragraph

Review in Pharmacoepidemiology and drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 6 countries.

Gerold T WhartonOffice of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-7177-9777
Claudia BeckerBasel Pharmacoepidemiology Unit, Division of Clinical Pharmacy & Epidemiology, Department of Pharmaceutical Sciences, University Basel, Basel, Switzerland.
Dimitri BennettGlobal Evidence and Outcomes, Safety Pharmacoepidemiology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.ORCID 0000-0002-8387-9342
Mehmet BurcuDepartment of Epidemiology, Merck & Co., Inc., Rahway, New Jersey, USA.ORCID 0000-0003-4572-0987
Greta BushnellDepartment of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.
Carmen FerrajoloCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Sigal KaplanDepartment Pharmacoepidemiology, Teva Pharmaceutical Industries Ltd, Netanya, Israel.ORCID 0000-0002-3352-8480
Ann W McMahonOffice of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0003-2617-6357
Naimisha MovvaEpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA.
Sudha R RamanDepartment of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA.
Oliver ScholleDepartment of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.ORCID 0000-0002-2633-6587
Mina SuhEpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA.
Jenny W SunSafety Surveillance Research, Pfizer Inc., New York, New York, USA.
Daniel B HortonDepartment of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.
BioStrategies (United States) · USRutgers, The State University of New Jersey · USUnited States Food and Drug Administration · USDuke University · USLeibniz Institute for Prevention Research and Epidemiology - BIPS · DEMerck & Co., Inc., Rahway, NJ, USA (United States) · USPfizer (United States) · USTakeda (United States) · USTeva Pharmaceuticals (Israel) · ILUniversity of Basel · CHUniversity of Campania "Luigi Vanvitelli" · IT

Funding

New Jersey Alliance for Clinical Translational Science: NJ ACTSUL1TR003017 · NCATS · RUTGERS BIOMEDICAL/HEALTH SCIENCES-RBHS · PI PANETTIERI, REYNOLD ALEXANDER · 2019 to 2023
$28.9M
Safety of Drugs Commonly Used Off-Label in Children Despite Insufficient Evidence of Efficacy and SafetyR01HD109335 · NICHD · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI Daniel Benjamin Horton · 2022 to 2026
$3.3M
COVID-19 Network of Networks Expanding Clinical and Translational approaches to Predict Severe Illness in Children (CONNECT to Predict SIck Children)R33HD105619 · NICHD · RUTGERS BIOMEDICAL AND HEALTH SCIENCES · PI GENNARO, MARIA LAURA, HORTON, DANIEL BENJAMIN · 2023 to 2023
$3.0M
Antibiotics, Juvenile Idiopathic Arthritis, and Antirheumatic Treatment ResponseR01AR074436 · NIAMS · RUTGERS, THE STATE UNIV OF N.J. · PI HORTON, DANIEL BENJAMIN · 2019 to 2022
$2.1M
COVID-19 Network of Networks Expanding Clinical and Translational approaches to Predict Severe Illness in Children (CONNECT to Predict SIck Children)R61HD105619 · NICHD · RBHS-ROBERT WOOD JOHNSON MEDICAL SCHOOL · PI GENNARO, MARIA LAURA, HORTON, DANIEL BENJAMIN · 2021 to 2022
$1.6M
NCATS NIH HHS UL1 TR003017NIAMS NIH HHS R01 AR074436NICHD NIH HHS R01 HD109335NICHD NIH HHS R33 HD105619NICHD NIH HHS R61 HD105619NIH HHS R01AR074436NIH HHS R01HD109335NIH HHS R33HD105619NIH HHS R61HD105619NIH HHS UL1TR003017
6 · The paper itself

Abstract

purposeGiven limited information available on real-world data (RWD) sources with pediatric populations, this study describes features of globally available RWD sources for pediatric pharmacoepidemiologic research.

methodsAn online questionnaire about pediatric RWD sources and their attributes and capabilities was completed by members and affiliates of the International Society for Pharmacoepidemiology and representatives of nominated databases. All responses were verified by database representatives and summarized.

resultsOf 93 RWD sources identified, 55 unique pediatric RWD sources were verified, including data from Europe (47%), United States (38%), multiregion (7%), Asia-Pacific (5%), and South America (2%). Most databases had nationwide coverage (82%), contained electronic health/medical records (47%) and/or administrative claims data (42%) and were linkable to other databases (65%). Most (71%) had limited outside access (e.g., by approval or through local collaborators); only 10 (18%) databases were publicly available. Six databases (11%) reported having >20 million pediatric observations. Most (91%) included children of all ages (birth until 18th birthday) and contained outpatient medication data (93%), while half (49%) contained inpatient medication data. Many databases captured vaccine information for children (71%), and one-third had regularly updated data on pediatric height (31%) and weight (33%). Other pediatric data attributes captured include diagnoses and comorbidities (89%), lab results (58%), vital signs (55%), devices (55%), imaging results (42%), narrative patient histories (35%), and genetic/biomarker data (22%).

conclusionsThis study provides an overview with key details about diverse databases that allow researchers to identify fit-for-purpose RWD sources suitable for pediatric pharmacoepidemiologic research.

Indexed as

Electronic Health RecordsPharmacoepidemiologyAsiaChildHumansInformation SourcesSurveys and QuestionnairesUnited Statesglobal databasespediatric researchpharmacoepidemiologyreal-world data sourcesreal-world evidence

Identifiers

PMID37690792
PMCPMC10840986
OpenAlexW4386588328

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.