Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Sequential testing for efficacy in clinical trials with non-transient effects.

James F Troendle1, Aiyi Liu, Chengqing Wu

  • 1Biometry and Mathematical Statistics Branch, Division of Epidemiology, Statistics, and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892, USA. jt3t@nih.gov

Statistics in Medicine
|October 6, 2005
PubMed
Summary

This study introduces novel sequential testing for clinical trials using extended follow-up times, not more patients. A Bonferroni-based method controls Type I errors, proving effective in analyzing treatment effects over time.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

DATA-ADAPTIVE EFFICIENT ESTIMATION STRATEGIES FOR BIOMARKER STUDIES EMBEDDED IN RANDOMIZED TRIALS.

The annals of applied statistics·2026
Same author

Development and Validation of the Childhood Interpersonal Trauma Questionnaire From Family, Teachers, and Peers (CITQ-FTP).

Journal of interpersonal violence·2026
Same author

The interplay between loneliness, cortisol, and NK cell function: The role of cortisol in NK cell dysfunction.

Psychoneuroendocrinology·2026
Same author

Latent profile transitions in bullying role behaviors and associated mental health problems among Chinese adolescents.

Journal of affective disorders·2026
Same author

Core depressive symptoms in middle-aged and older adults in the USA, England, China, and Mexico: Evidence from network analysis.

Asian journal of psychiatry·2026
Same author

NHLBI Workshop Panel Discussion: Summary of the Workshop.

Statistics in medicine·2026

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Methods

Background:

  • Sequential testing in clinical trials typically involves analyzing data as it accrues from new patients.
  • Existing methods may not adequately address scenarios where data accrual is driven by extended patient follow-up durations.

Purpose of the Study:

  • To develop and evaluate a novel sequential testing framework for clinical trials utilizing extended patient follow-up times.
  • To establish methods for controlling Type I error rates in sequential analyses based on time-dependent outcomes.

Main Methods:

  • A general method based on the Bonferroni inequality is proposed to determine critical cutpoints for sequential testing.
  • Statistical hypothesis testing at each analysis focuses on treatment equivalence at specific follow-up times.

Related Experiment Videos

  • Monte-Carlo simulations are employed to compare the proposed methods, particularly for two-armed trials with Gaussian outcomes.

    • Main Results:

    • The Bonferroni inequality provides a general approach to control Type I error rates in this sequential testing framework.
    • Simulation studies indicate that the Bonferroni method is generally not overly conservative in practical applications.
    • The methodology was illustrated using a clinical trial of Pirfenidone for pulmonary fibrosis.

    Conclusions:

    • The proposed sequential testing approach, leveraging extended follow-up, offers a viable strategy for clinical trial analysis.
    • The Bonferroni-based method effectively controls the overall Type I error rate for clinical decisions.
    • This framework is applicable across various statistical tests and trial designs, enhancing sequential analysis capabilities.