ArticleClinical pharmacology and therapeutics2018
Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.
Article in Clinical pharmacology and therapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed.
- Model-Informed Approaches for Pediatric Type 2 Diabetes Evidence Generation: Insights from a Model-Based Longitudinal HbA1c Meta-Analysis from EMA Marketing Authorization Applications.Clinical pharmacology and therapeutics · 2026Article
- Predictors of the Effectiveness of Psychedelics in Treating Depression-A Scoping Review.International journal of molecular sciences · 2026Article
- Bridging the United States population diversity gaps in clinical research: roadmap to precision health and reducing health disparities.Personalized medicine · 2025Review
- The Imperative to Enhance Cost-Effectiveness for Cardiovascular Therapeutic Development.JACC. Basic to translational science · 2024Review
- The Revolution in Pediatric Drug Development and Drug Use: Therapeutic Orphans No More.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020Article
- The "rights" of precision drug development for Alzheimer's disease.Alzheimer's research & therapy · 2019Review
- Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA.Journal of clinical pharmacology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis.
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.