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

Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.

N L Geller, S J Pocock

    Biometrics
    |March 1, 1987
    PubMed
    Summary

    Group sequential methods significantly impact randomized clinical trial design and analysis. This work provides guidelines for interim analyses, sample size, and identifies areas for future research in clinical trial methodology.

    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

    Effects of oral salbutamol and pirbuterol on FEV1, heart rate and blood pressure in asthmatics.

    British journal of clinical pharmacology·2012
    Same author

    [The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting of observational studies].

    Der Internist·2008
    Same author

    Rosiglitazone increased heart failure but did not differ from metformin plus sulphonylurea for other CV outcomes at interim analysis.

    Evidence-based medicine·2007
    Same author

    The cost-effectiveness of an early interventional strategy in non-ST-elevation acute coronary syndrome based on the RITA 3 trial.

    Heart (British Cardiac Society)·2007
    Same author

    Rosiglitazone RECORD study: glucose control outcomes at 18 months.

    Diabetic medicine : a journal of the British Diabetic Association·2007
    Same author

    Prevalence and prognostic implications of electrocardiographic left ventricular hypertrophy in heart failure: evidence from the CHARM programme.

    Heart (British Cardiac Society)·2006

    Area of Science:

    • Biostatistics
    • Clinical Trial Design
    • Medical Research Methodology

    Background:

    • Group sequential methods are increasingly vital for modern clinical trial design.
    • Interim analyses allow for early trial assessments, impacting resource allocation and ethical considerations.
    • Randomized clinical trials (RCTs) benefit from adaptive designs that incorporate sequential analysis.

    Purpose of the Study:

    • To discuss the impact of group sequential methods on RCT design and analysis.
    • To provide practical guidelines for conducting planned and unplanned interim analyses.
    • To highlight areas requiring further theoretical development in group sequential methods.

    Main Methods:

    • Review of recent developments in group sequential statistical methods.

    Related Experiment Videos

  • Illustrative examples using real-world clinical trial data.
  • Presentation of tables for nominal significance levels and sample size calculations for various group sequential plans.

    • Main Results:

    • Group sequential methods offer flexibility in trial conduct through interim analyses.
    • Guidelines and practical tools (tables) are provided for implementing these methods.
    • Key areas for future research are identified, including multiple endpoints and multi-armed trials.

    Conclusions:

    • Group sequential methods are essential for efficient and ethical RCTs.
    • Further theoretical advancements are needed to address complex trial designs.
    • The findings offer practical guidance for statisticians and researchers involved in clinical trials.