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

Crossover Experiments01:16

Crossover Experiments

2.7K
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
2.7K
Group Design02:01

Group Design

8.9K
The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between...
8.9K
Factorial Design02:01

Factorial Design

13.0K
Factorial Analysis is an experimental design that applies Analysis of Variance (ANOVA) statistical procedures to examine a change in a dependent variable due to more than one independent variable, also known as factors. Changes in worker productivity can be reasoned, for example, to be influenced by salary and other conditions, such as skill level. One way to test this hypothesis is by categorizing salary into three levels (low, moderate, and high) and skills sets into two levels (entry level...
13.0K
Strategies for Assessing and Addressing Confounding01:25

Strategies for Assessing and Addressing Confounding

79
Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
79
Randomized Experiments01:13

Randomized Experiments

6.7K
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...
6.7K
Censoring Survival Data01:09

Censoring Survival Data

55
Survival analysis is a statistical method used to analyze time-to-event data, often employed in fields such as medicine, engineering, and social sciences. One of the key challenges in survival analysis is dealing with incomplete data, a phenomenon known as "censoring." Censoring occurs when the event of interest (such as death, relapse, or system failure) has not occurred for some individuals by the end of the study period or is otherwise unobservable, and it might have many different...
55

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
Same journal

An Adaptive Biomarker-based Umbrella Trial Design Using Bayesian Latent Class Model.

Statistics in biopharmaceutical research·2026
Same journal

A Bayesian Adaptive Marker-Stratified Design for Phase II Clinical Trials Using Calibrated Spike-and-Slab priors.

Statistics in biopharmaceutical research·2026
Same journal

On the Two-Step Hybrid Design for Augmenting Randomized Trials Using Real-World Data.

Statistics in biopharmaceutical research·2025
Same journal

Two-stage Adaptive Enrichment Designs with Survival Outcomes and Adjustment for Misclassification in Predictive Biomarkers.

Statistics in biopharmaceutical research·2025
Same journal

A novel longitudinal rank-sum test for multiple primary endpoints in clinical trials: Applications to neurodegenerative disorders.

Statistics in biopharmaceutical research·2025
Same journal

Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes.

Statistics in biopharmaceutical research·2025
See all related articles

Related Experiment Video

Updated: May 23, 2025

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

16.4K

A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design.

Li Yang1, Guoqing Diao2, William F Rosenberger3

  • 1Translational Biobehavioral and Health Disparities Branch, National Institutes of Health Clinical Center, Bethesda, MD.

Statistics in Biopharmaceutical Research
|May 20, 2025
PubMed
Summary
This summary is machine-generated.

This study introduces a two-stage enrichment design for clinical trials to identify patient subgroups benefiting most from treatment. It uses covariate-adjusted response-adaptive (CARA) allocation and an interim analysis to adapt trial recruitment for improved efficiency and patient care.

Keywords:
Adaptive designsPermutation testPrecision medicineRandomization testThreshold

More Related Videos

A Protocol for Using Gene Set Enrichment Analysis to Identify the Appropriate Animal Model for Translational Research
09:35

A Protocol for Using Gene Set Enrichment Analysis to Identify the Appropriate Animal Model for Translational Research

Published on: August 16, 2017

17.7K
The Use of the Puzzle Box as a Means of Assessing the Efficacy of Environmental Enrichment
06:50

The Use of the Puzzle Box as a Means of Assessing the Efficacy of Environmental Enrichment

Published on: December 29, 2014

11.6K

Related Experiment Videos

Last Updated: May 23, 2025

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

16.4K
A Protocol for Using Gene Set Enrichment Analysis to Identify the Appropriate Animal Model for Translational Research
09:35

A Protocol for Using Gene Set Enrichment Analysis to Identify the Appropriate Animal Model for Translational Research

Published on: August 16, 2017

17.7K
The Use of the Puzzle Box as a Means of Assessing the Efficacy of Environmental Enrichment
06:50

The Use of the Puzzle Box as a Means of Assessing the Efficacy of Environmental Enrichment

Published on: December 29, 2014

11.6K

Area of Science:

  • Clinical trial design
  • Precision medicine
  • Biostatistics

Background:

  • Identifying patient subgroups that benefit most from treatment is crucial in precision medicine.
  • Traditional clinical trials often assume no treatment-by-covariate interactions, leading to inefficient enrollment and unnecessary treatment for some patients.

Purpose of the Study:

  • To propose a novel two-stage enrichment design for clinical trials.
  • To improve trial efficiency and patient outcomes by identifying and focusing on subgroups with the greatest treatment benefit.

Main Methods:

  • Utilizes covariate-adjusted response-adaptive (CARA) allocation for patient enrollment.
  • Incorporates a pseudo-randomization test in interim analysis to detect treatment-by-covariate interactions.
  • Employs a pre-defined alpha threshold to decide on subgroup recruitment for the second stage.

Main Results:

  • The design allows for adaptation based on interim analysis findings, focusing on the best-performing subgroup if a significant interaction is detected.
  • Evaluates different CARA procedures based on type I error rates, power, and ethical considerations.
  • Selects the CARA procedure that optimally balances trial efficiency and ethical considerations.

Conclusions:

  • The proposed two-stage enrichment design enhances precision medicine by enabling early identification of treatment-effect subgroups.
  • This adaptive approach optimizes resource allocation and minimizes patient exposure to ineffective treatments.
  • The study provides a framework for more efficient and ethical clinical trial conduct.