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

Assessing non-inferiority: a combination approach.

Ping Gao1, James H Ware

  • 1The Medicines Company, 8 Campus Drive, Parsippany, NJ 07054, USA. ping.gao@themedco.com

Statistics in Medicine
|June 19, 2007
PubMed
Summary
This summary is machine-generated.

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

Anti-Obesity Effects of Dietary Calcium: The Evidence and Possible Mechanisms.

International journal of molecular sciences·2019
Same author

Vitamin D Supplementation and Prevention of Type 2 Diabetes.

The New England journal of medicine·2019
Same author

Vacancy defective perovskite Na<sub>0.85</sub>Ni<sub>0.45</sub>Co<sub>0.55</sub>F<sub>3.56</sub> nanocrystal anodes for advanced lithium-ion storage driven by surface conversion and insertion hybrid mechanisms.

Chemical communications (Cambridge, England)·2019
Same author

Subacute Phase After an Earthquake: An Even More Important Period.

Disaster medicine and public health preparedness·2019
Same author

Retraction Note: RNAi targeting CXCR4 inhibits proliferation and invasion of esophageal carcinoma cells.

Diagnostic pathology·2019
Same author

2-Oxonanonoidal Antibiotic Actinolactomycin Inhibits Cancer Progression by Suppressing HIF-1α.

Cells·2019
Same journal

Optimal Weighted Tests for Replication Studies and the 'Two-Trials Rule' With Multiple Hypotheses.

Statistics in medicine·2026
Same journal

Identifiable Copula-Double-Cox Models: A Fully Parametric Framework for Dependent Right-Censored Survival Data.

Statistics in medicine·2026
Same journal

Moving From Individualized Risk-Based Prevention to Benefit-Based Prevention: Estimating Individualized Life-Years Gained From Prevention Services as a Basis for Eligibility.

Statistics in medicine·2026
Same journal

A Mixture of Distributed Lag Non-Linear Models to Account for Spatially Heterogeneous Exposure-Lag-Response Associations.

Statistics in medicine·2026
Same journal

Practical Considerations for Gaussian Process Modeling for Causal Inference in Quasi-Experimental Studies With Panel Data.

Statistics in medicine·2026
Same journal

Covariate Adjustment for Wilcoxon Two Sample Statistic and Test.

Statistics in medicine·2026
See all related articles

Non-inferiority trials compare new drugs to existing ones. This study proposes a new method to ensure new drugs are not only not worse than existing ones but also better than placebo, addressing controversies in drug development.

Area of Science:

  • Clinical Trials
  • Pharmaceutical Research
  • Biostatistics

Background:

  • Non-inferiority trial designs are increasingly used for comparing new drugs against established therapies.
  • Choosing the non-inferiority margin is subjective and has led to controversies impacting drug development.
  • Existing non-inferiority trials often fail to explicitly address the dual objectives of demonstrating non-inferiority to a control and superiority to placebo.

Purpose of the Study:

  • To address controversies in non-inferiority trial design by proposing a novel analytical approach.
  • To ensure that new drugs demonstrate not only non-inferiority to a control but also superiority to a placebo.
  • To refine the selection of the non-inferiority margin by considering both trial objectives.

Main Methods:

Related Experiment Videos

  • Introduced a new approach combining a traditional non-inferiority test with a superiority test using a synthetic treatment-placebo effect estimate.
  • The synthetic estimate can be discounted to account for potential assay inconstancy.
  • Discussed power and sample size considerations for the proposed analytical procedure.

    • Main Results:

    • The proposed method provides a more robust framework for non-inferiority analysis by integrating the comparison to both control and placebo.
    • Addresses the distortion in non-inferiority margin selection that arises when the superiority-to-placebo objective is not explicitly considered.
    • Offers a potential solution to overly stringent non-inferiority criteria sometimes imposed by existing methods.

    Conclusions:

    • The proposed analytical approach enhances the rigor of non-inferiority trials.
    • This method helps resolve controversies surrounding the non-inferiority margin by explicitly accounting for the comparison to placebo.
    • Provides a framework for more reliable drug development decisions through improved trial design and analysis.