ArticlePloS one2017
Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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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.
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Who cites it
9 citing papers in PubMed.
- Long-term safety and efficacy of sodium zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-stage chronic kidney disease: comparative results from an open-label, Phase 3 study.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021Trial
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response.Frontiers in drug safety and regulation · 2025Article
- MedDRA Labeling Groupings to Improve Safety Communication in Product Labels.Therapeutic innovation & regulatory science · 2023Article
- Prediction of Adverse Drug Reaction Linked to Protein Targets Using Network-Based Information and Machine Learning.Frontiers in bioinformatics · 2022Article
- Mining drug-target and drug-adverse drug reaction databases to identify target-adverse drug reaction relationships.Database : the journal of biological databases and curation · 2021Article
- Cardiotoxicity Associated with Gemcitabine: Literature Review and a Pharmacovigilance Study.Pharmaceuticals (Basel, Switzerland) · 2020Article
- A Comprehensive Methodology to Systematically Identify Drug Hypersensitivity and Anaphylactic Reactions in Clinical Trial Databases.Pharmaceutical medicine · 2020Article
- A Critical Evaluation of Safety Signal Analysis Using Algorithmic Standardised MedDRA Queries.Drug safety · 2018Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeStandardised MedDRA Queries (SMQs) have been developed since the early 2000's and used by academia, industry, public health, and government sectors for detecting safety signals in adverse event safety databases. The purpose of the present study is to characterize how SMQs are used and the impact in safety analyses for New Drug Application (NDA) and Biologics License Application (BLA) submissions to the United States Food and Drug Administration (USFDA).
methodsWe used the PharmaPendium database to capture SMQ use in Summary Basis of Approvals (SBoAs) of drugs and biologics approved by the USFDA. Characteristics of the drugs and the SMQ use were employed to evaluate the role of SMQ safety analyses in regulatory decisions and the veracity of signals they revealed.
resultsA comprehensive search of the SBoAs yielded 184 regulatory submissions approved from 2006 to 2015. Search strategies more frequently utilized restrictive searches with "narrow terms" to enhance specificity over strategies using "broad terms" to increase sensitivity, while some involved modification of search terms. A majority (59%) of 1290 searches used descriptive statistics, however inferential statistics were utilized in 35% of them. Commentary from reviewers and supervisory staff suggested that a small, yet notable percentage (18%) of 1290 searches supported regulatory decisions. The searches with regulatory impact were found in 73 submissions (40% of the submissions investigated). Most searches (75% of 227 searches) with regulatory implications described how the searches were confirmed, indicating prudence in the decision-making process.
conclusionsSMQs have an increasing role in the presentation and review of safety analysis for NDAs/BLAs and their regulatory reviews. This study suggests that SMQs are best used for screening process, with descriptive statistics, description of SMQ modifications, and systematic verification of cases which is crucial for drawing regulatory conclusions.
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