ArticleRevstat statistical journal2017
Continuous Post-Market Sequential Safety Surveillance with Minimum Events to Signal.
Article in Revstat statistical journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled 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.
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
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Near real-time vaccine safety surveillance using electronic health records-a systematic review of the application of statistical methods.Pharmacoepidemiology and drug safety · 2016Pooled it
- Sequential Epidemiological Analyses of Real-World Data: A Tool for Prospective Drug Safety Surveillance from the Rofecoxib Example.Drug safety · 2025Article
- Real-Time Pharmacovigilance: Transforming Population-Based Monitoring of Post-Approval Vaccine Safety Through Rapid Cycle Analysis (RCA)-A Review of the Published Literature.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Article
- Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data.Statistics in medicine · 2021Article
- Exact conditional maximized sequential probability ratio test adjusted for covariates.Sequential analysis · 2019Article
- Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.Statistics in medicine · 2018Article
- A Synthesis of Current Surveillance Planning Methods for the Sequential Monitoring of Drug and Vaccine Adverse Effects Using Electronic Health Care Data.EGEMS (Washington, DC) · 2016Article
- Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.Biometrics · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 1 country.
Funding
Abstract
The CDC Vaccine Safety Datalink project has pioneered the use of near real-time post-market vaccine safety surveillance for the rapid detection of adverse events. Doing weekly analyses, continuous sequential methods are used, allowing investigators to evaluate the data near-continuously while still maintaining the correct overall alpha level. With continuous sequential monitoring, the null hypothesis may be rejected after only one or two adverse events are observed. In this paper, we explore continuous sequential monitoring when we do not allow the null to be rejected until a minimum number of observed events have occurred. We also evaluate continuous sequential analysis with a delayed start until a certain sample size has been attained. Tables with exact critical values, statistical power and the average times to signal are provided. We show that, with the first option, it is possible to both increase the power and reduce the expected time to signal, while keeping the alpha level the same. The second option is only useful if the start of the surveillance is delayed for logistical reasons, when there is a group of data available at the first analysis, followed by continuous or near-continuous monitoring thereafter.
Indexed as
Identifiers
34393695PMC8363220W1505117888What 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.