Exact sequential test for clinical trials and post-market drug and vaccine safety surveillance with Poisson and binary data.
Stat Med
; 40(22): 4890-4913, 2021 09 30.
Article
in English
| MEDLINE | ID: covidwho-1265406
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.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pharmaceutical Preparations
/
COVID-19
Type of study:
Cohort study
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Stat Med
Year:
2021
Document Type:
Article
Affiliation country:
Sim.9094
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