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

Statistical analysis for two-stage seamless design with different study endpoints.

Shein-Chung Chow1, Qingshu Lu, Siu-Keung Tse

  • 1Department of Biostatistics & Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA.

Journal of Biopharmaceutical Statistics
|November 21, 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

The pyruvate kinase activator etavopivat (FT-4202) limits pulmonary and systemic sequelae of sepsis in a mouse LPS model.

American journal of physiology. Lung cellular and molecular physiology·2026
Same author

Power Calculation for Non-inferiority Test Based on Linear Combination of Two Correlated Binary Endpoints.

Therapeutic innovation & regulatory science·2026
Same author

Controversial issues in clinical investigation of rare disease drug development.

Journal of biopharmaceutical statistics·2026
Same author

Switching Design for Assessment of Interchangeability in Biosimilar Studies.

Pharmaceutics·2026
Same author

Acupuncture for acute musculoskeletal pain in the emergency department and clinic: a pragmatic randomized trial.

Pain medicine (Malden, Mass.)·2025
Same author

Study Protocol: Single-Blinded, Controlled, Clinical Trial Evaluating the Feasibility of Spinal Cord Stimulation for Improving Neuropathic Pain and Rehabilitation Outcomes in Patients With Thoracic Spinal Cord Injury.

Neurosurgery practice·2025
Same journal

Correction.

Journal of biopharmaceutical statistics·2026
Same journal

Leveraging external controls in clinical trials: estimands, estimation, assumptions.

Journal of biopharmaceutical statistics·2026
Same journal

Special issue of nonclinical statistics in regulatory applications guest editors' notes.

Journal of biopharmaceutical statistics·2026
Same journal

Comparison of flexible parametric modeling and nonparametric methods to estimate restricted mean survival time: A simulation study.

Journal of biopharmaceutical statistics·2026
Same journal

Simulated treatment comparisons with jackknife pseudo values for estimating population-adjusted marginal treatment effects.

Journal of biopharmaceutical statistics·2026
Same journal

Sample sizes for randomized controlled trials utilizing Bayesian response adaptive randomization for continuous outcomes.

Journal of biopharmaceutical statistics·2026
See all related articles

This study introduces a new statistical method for adaptive seamless Phase II/III trials. It enables combining data from different study endpoints, crucial for pharmaceutical development efficiency.

Area of Science:

  • Clinical Trials Methodology
  • Pharmaceutical Development
  • Biostatistics

Background:

  • Adaptive seamless trial designs integrate Phase II and Phase III studies for efficiency.
  • Different study endpoints can arise in seamless trials due to long treatment durations.
  • Existing methods may not adequately handle combined data with disparate endpoints.

Purpose of the Study:

  • To propose a novel test statistic for analyzing combined data in adaptive seamless Phase II/III trials with different endpoints.
  • To develop a sample size calculation formula based on the proposed test statistic.
  • To discuss optimal sample size allocation across trial phases.

Main Methods:

  • Development of a test statistic that leverages data from both learning (Phase II) and confirmatory (Phase III) phases.

Related Experiment Videos

  • Derivation of a sample size formula accommodating the proposed test statistic and endpoint relationship.
  • Exploration of strategies for sample size allocation between the two phases.

    • Main Results:

    • A valid test statistic is proposed for combined analysis of data from distinct endpoints in seamless trials.
    • A derived sample size formula provides a basis for planning such trials.
    • Guidelines for sample size allocation are discussed to optimize trial power.

    Conclusions:

    • The proposed methodology facilitates robust analysis in adaptive seamless trials with differing endpoints.
    • Accurate sample size determination is achievable, enhancing trial design.
    • This approach supports efficient pharmaceutical development by integrating study phases effectively.