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

Sample Size Calculation01:19

Sample Size Calculation

6.2K
Knowledge of the sample size is the first requirement to conduct random sampling or an experiment. The sample size is the total number of units, observations, or groups (in some cases) used to get the data to estimate a population parameter. As the name suggests, the sample size is that of the sample drawn from the population and differs from the population size.
The sample size for the given experiment or sampling effort is fundamental to any study design. Sample size decides the number of...
6.2K
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

164
Body: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...
164
One-Way ANOVA: Unequal Sample Sizes01:15

One-Way ANOVA: Unequal Sample Sizes

6.6K
One-way ANOVA can be performed on three or more samples of unequal sizes. However, calculations get complicated when sample sizes are not always the same. So, while performing ANOVA with unequal samples size, the following equation is used:
6.6K
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

210
Body: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...
210
Randomized Experiments01:13

Randomized Experiments

8.8K
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...
8.8K
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

538
Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and...
538

You might also read

Related Articles

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

Sort by
Same author

Statistical models for Alzheimer's disease clinical trials: Lessons learned from the DIAN-TU Platform Trial.

Journal of Alzheimer's disease : JAD·2026
Same author

Penalized estimation of linear transformation models for interval-censored data with time-dependent covariates.

Statistical methods in medical research·2026
Same author

Impact of male genital tract infections on semen quality: a systematic review and meta-analysis.

Fertility and sterility·2026
Same author

Testing disease progression under the proportional reduction in decline in Alzheimer's disease studies.

Journal of applied statistics·2026
Same author

Likelihood ratio test for the disease progression model to measure saved time in Alzheimer's disease.

Statistical methods in medical research·2026
Same author

Lanthanide Complex-Based Probes for Ratiometric Time-Gated Luminescence and <sup>19</sup>F Magnetic Resonance Imaging of Hydrogen Peroxide <i>In Vitro</i> and <i>In Vivo</i>.

Analytical chemistry·2025
Same journal

A joint model for a longitudinal outcome and a progressive multistate model under a mixed observation scheme.

Statistical methods in medical research·2026
Same journal

Efficient semi-supervised estimation of optimal individualized treatment regimes with survival outcome.

Statistical methods in medical research·2026
Same journal

Asymptotic online FWER control for dependent test statistics.

Statistical methods in medical research·2026
Same journal

Regression analysis of misclassified current status data with potentially unknown test accuracy.

Statistical methods in medical research·2026
Same journal

Bayesian multivariate linear mixed-effects models with varied association structures.

Statistical methods in medical research·2026
Same journal

Inference about the ratio of age-standardized rates between two overlapping populations.

Statistical methods in medical research·2026
See all related articles

Related Experiment Video

Updated: Jan 10, 2026

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
08:36

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

1.1K

Adaptive sample size re-estimation designs for a two-stage randomized trial with binary outcome.

Zhixin Tang1, Guogen Shan1

  • 1Department of Biostatistics, University of Florida, USA.

Statistical Methods in Medical Research
|November 27, 2025
PubMed
Summary
This summary is machine-generated.

New adaptive and promising zone designs for early phase trials improve efficiency and participant safety. These methods offer better statistical power and sample size management compared to traditional group sequential designs.

Keywords:
Adaptive designbinary outcomegroup sequential designpromising zone designrandomized trialtwo-stage design

More Related Videos

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
06:55

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

15.0K
Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
20:24

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study

Published on: January 31, 2014

17.1K

Related Experiment Videos

Last Updated: Jan 10, 2026

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
08:36

Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment

Published on: April 19, 2024

1.1K
Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
06:55

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

15.0K
Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study
20:24

Characterization of Complex Systems Using the Design of Experiments Approach: Transient Protein Expression in Tobacco as a Case Study

Published on: January 31, 2014

17.1K

Area of Science:

  • Clinical Trials
  • Biostatistics
  • Experimental Design

Background:

  • Group sequential designs can reduce sample size and protect participants in early phase trials.
  • Exact binomial distribution is preferred for binary outcomes over asymptotic distributions in group sequential designs.
  • Traditional one-stage designs may not be as efficient or protective as sequential methods.

Purpose of the Study:

  • To develop novel parallel two-stage adaptive and promising zone designs for early phase clinical trials.
  • To allow for sample size adjustments in the second stage based on first-stage outcomes.
  • To ensure conditional probability is guaranteed when trials proceed to the second stage.

Main Methods:

  • Proposed parallel two-stage adaptive design with sample size re-estimation.
  • Developed a promising zone design incorporating sample size adjustment.
  • Ensured Type I error rate control and conditional probability constraints.
  • Utilized exact binomial distribution for binary outcomes.

Main Results:

  • The proposed adaptive design significantly increases unconditional power but requires larger sample sizes.
  • The promising zone design balances statistical power and expected sample size effectively.
  • Both proposed designs control Type I error rates and guarantee conditional probability constraints.
  • A cancer trial example demonstrated the practical application and benefits of the new designs.

Conclusions:

  • Adaptive and promising zone designs offer enhanced efficiency and participant protection in early phase trials.
  • The promising zone design provides a favorable trade-off between statistical power and sample size.
  • These advanced designs represent improvements over traditional group sequential and one-stage designs for binary outcomes.