ArticlePediatrics2010
Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity.
Article in Pediatrics, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
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.
Who cites it
16 citing papers in PubMed.
- Enhancing Drug Development for Paediatric Pulmonary Hypertension-An Integrative Perspective.Pulmonary circulation · 2025Review
- Updated analysis of pediatric clinical studies registered in ClinicalTrials.gov, 2008-2019.BMC pediatrics · 2021Article
- Pediatric melanoma-The whole (conflicts of interest) story.International journal of women's dermatology · 2019Review
- Global Disparities Between Pediatric Publications and Disease Burden From 2006 to 2015.Global pediatric health · 2019Article
- Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study.Journal of pharmaceutical policy and practice · 2017Article
- Children with multiple sclerosis should not become therapeutic hostages.Therapeutic advances in neurological disorders · 2016Review
- Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency.Children (Basel, Switzerland) · 2015Review
- Geographic location of antiretroviral clinical trials in HIV infected pediatric patients.International journal of clinical pharmacy · 2013Article
- Reflection: medicines for children--science alone is not enough.European journal of clinical pharmacology · 2013Article
- "Not just little adults": qualitative methods to support the development of pediatric patient-reported outcomes.The patient · 2013Review
- Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.Pediatrics · 2012Article
- Article
- The status of paediatric medicines initiatives around the world--What has happened and what has not?European journal of clinical pharmacology · 2012Review
- Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future.Paediatric drugs · 2011Article
- The globalization of pediatric trials: should we be worried?Pediatrics · 2011Article
- As pediatric trials go global, some worry who really benefits.Nature medicine · 2010Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
objectiveWe evaluated the setting of published studies conducted under the US Pediatric Exclusivity Provision, which provides economic incentives to pharmaceutical companies to conduct drug studies with children.
methodsPublished studies containing the main results of trials conducted in 1998-2007 under the Pediatric Exclusivity Provision were included. Data were extracted from each study and described, including the therapeutic area of drug studied, number of patients enrolled, number of sites, and location where the study was conducted, if reported.
resultsOverall, 174 trials were included (sample size: 8-27 065 patients); 9% did not report any information regarding the location or number of sites where the study was conducted. Of trials that did report such information, 65% were conducted in >or=1 country outside the United States, and 11% did not include any sites in the United States. Fifty-four countries were represented, and 38% of trials enrolled patients in >or=1 site located in a developing/transition country, including more than one-third of infectious disease, cardiovascular, and allergy/immunology trials.
conclusionsThe majority of published pediatric trials conducted under the Pediatric Exclusivity Provision included sites outside the United States, and more than one-third of trials enrolled patients in developing/transition countries.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.