Evidence map›Paper›PMID 34120357›Full record

ArticleStatistics in medicine2021

Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data.

Ivair R Silva, Judith Maro, Martin Kulldorff

Abstract read
In one paragraph

Article in Statistics in medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

  1. Robust Alpha Spending for Unstable Data.Statistics in medicine · 2026
    Article
  2. Article
  3. Article
  4. Sequential Event Rate Monitoring.Statistics in medicine · 2026
    Article
  5. Article
  6. Article
  7. Article
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

3 authors.

Ivair R SilvaDepartment of Statistics, Federal University of Ouro Preto, Ouro Preto, Brazil.ORCID 0000-0003-2701-8924
Judith MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
Martin KulldorffDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts, USA.

Funding

Software for Near Real-Time Post-Market Drug and Vaccine Safety SurveillanceR01GM108999 · NIGMS · HARVARD PILGRIM HEALTH CARE, INC. · PI KULLDORFF, MARTIN · 2014 to 2017
$1.1M
Conselho Nacional de Desenvolvimento Científico e Tecnológico 301391/2019-0NIGMS NIH HHS R01 GM108999NIGMS NIH HHS RO1GM108999
6 · The paper itself

Abstract

In sequential analysis, hypothesis testing is performed repeatedly in a prospective manner as data accrue over time to quickly arrive at an accurate conclusion or decision. In this tutorial paper, detailed explanations are given for both designing and operating sequential testing. We describe the calculation of exact thresholds for stopping or signaling, statistical power, expected time to signal, and expected sample sizes for sequential analysis with Poisson and binary type data. The calculations are run using the package Sequential, constructed in R language. Real data examples are inspired on clinical trials practice, such as the current efforts to develop treatments to face the COVID-19 pandemic, and the comparison of treatments of osteoporosis. In addition, we mimic the monitoring of adverse events following influenza vaccination and Pediarix vaccination.

Indexed as

COVID-19Pharmaceutical PreparationsHumansPandemicsProspective StudiesSARS-CoV-2Pharmaceutical Preparationsadaptive designalpha spendingcontinuous monitoringgroup sequential

Identifiers

PMID34120357
PMCPMC8441767

What OpenQuestion holds

Textmetadata
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.