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 Concept Videos

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...

You might also read

Related Articles

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

Sort by
Same author

Information-Based Composite Likelihood Method for Hybrid Meta-Analysis Integrating Individual Participant Data and Aggregated Data.

Statistics in medicine·2026
Same author

Strategies for forecasting long COVID in the active component U.S. military.

MSMR·2026
Same author

Desirability of outcome ranking (DOOR) analysis for multivariate survival outcomes with application to ACTT-1 trial.

Clinical trials (London, England)·2025
Same author

Statewide Transfer Coordination and Patient Transfer Rates Among Hospitals During Occupancy Stress.

JAMA network open·2025
Same author

A patient-centric paradigm and tool for clinical research: the DOOR is open.

Antimicrobial agents and chemotherapy·2025
Same author

A Bayesian approach towards the identification of latent subgroups.

Statistical methods in medical research·2025

Related Experiment Video

Updated: Jul 10, 2026

Characterizing the Relationship Between Eye Movement Parameters and Cognitive Functions in Non-demented Parkinson's Disease Patients with Eye Tracking
07:26

Characterizing the Relationship Between Eye Movement Parameters and Cognitive Functions in Non-demented Parkinson's Disease Patients with Eye Tracking

Published on: September 26, 2019

Group Sequential Design and Monitoring of Clustered Data in Randomized Eye Trials.

Guoqing Diao1, Qiang Zhang2,3, Toshimitsu Hamasaki1

  • 1Department of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C.

Statistics in Biopharmaceutical Research
|July 9, 2026
PubMed
Summary

This study introduces a unified group sequential design for clinical trials in vision research, accounting for inter-eye correlation. This method improves accuracy in interim monitoring, preventing unnecessary study delays or premature conclusions.

Keywords:
adaptive designalpha spendinginformation timeinterim analysislinear mixed modelsample size/power calculation

More Related Videos

Eye-tracking Technology and Data-mining Techniques used for a Behavioral Analysis of Adults engaged in Learning Processes
10:43

Eye-tracking Technology and Data-mining Techniques used for a Behavioral Analysis of Adults engaged in Learning Processes

Published on: June 10, 2021

Eye-Tracking Control to Assess Cognitive Functions in Patients with Amyotrophic Lateral Sclerosis
07:00

Eye-Tracking Control to Assess Cognitive Functions in Patients with Amyotrophic Lateral Sclerosis

Published on: October 13, 2016

Related Experiment Videos

Last Updated: Jul 10, 2026

Characterizing the Relationship Between Eye Movement Parameters and Cognitive Functions in Non-demented Parkinson's Disease Patients with Eye Tracking
07:26

Characterizing the Relationship Between Eye Movement Parameters and Cognitive Functions in Non-demented Parkinson's Disease Patients with Eye Tracking

Published on: September 26, 2019

Eye-tracking Technology and Data-mining Techniques used for a Behavioral Analysis of Adults engaged in Learning Processes
10:43

Eye-tracking Technology and Data-mining Techniques used for a Behavioral Analysis of Adults engaged in Learning Processes

Published on: June 10, 2021

Eye-Tracking Control to Assess Cognitive Functions in Patients with Amyotrophic Lateral Sclerosis
07:00

Eye-Tracking Control to Assess Cognitive Functions in Patients with Amyotrophic Lateral Sclerosis

Published on: October 13, 2016

Area of Science:

  • Ophthalmology and Clinical Trials
  • Biostatistics and Clinical Trial Design

Background:

  • Group sequential designs are standard for randomized clinical trials, offering interim monitoring to control Type I error rates and preserve statistical power.
  • Existing group sequential methods lack unified designs that specifically address inter-eye correlation in randomized eye trials.
  • Failure to account for inter-eye correlations can result in suboptimal trial duration, either unnecessarily extending the study or leading to premature cessation.

Purpose of the Study:

  • To propose a unified group sequential design for vision research that incorporates inter-eye correlation.
  • To provide a flexible design accommodating various options while accounting for paired eye data in randomized eye trials.
  • To offer accurate sample size, power calculations, and interim monitoring strategies for continuous endpoints.

Main Methods:

  • Development of closed-form formulae for sample size and power calculations in fixed-sample designs.
  • Derivation of information fractions for interim monitoring within group sequential designs.
  • Methodology explicitly accounts for inter-eye correlation for continuous endpoints in clinical trials involving paired eye data.

Main Results:

  • The proposed unified design effectively incorporates inter-eye correlation into group sequential trial planning for vision research.
  • Closed-form formulae enable precise sample size and power calculations, enhancing efficiency.
  • The methodology was validated through simulation studies and applied to the Age-Related Eye Disease Study.

Conclusions:

  • The developed unified group sequential design provides a statistically sound approach for randomized eye trials with paired data.
  • Accounting for inter-eye correlation leads to more appropriate study durations and resource allocation.
  • The R package 'iTrial' is available for implementing this advanced methodology in clinical research.