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

Study Design in Statistics01:15

Study Design in Statistics

8.6K
A study design is a set of techniques that allow a researcher to collect and analyze data from different variables defined for a specific research problem. Statistics is commonly for effective study design and more robust experiments,
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
8.6K
Experimental Designs01:16

Experimental Designs

14.3K
An experimental design is a systematic process that allows researchers to evaluate the relationship between dependent and independent variables. There are three widely used types of experimental design - pre-experimental design, true experimental design, and quasi-experimental design. In pre-experimental design, the researcher compares the data before and after some interventions or treatments. The true-experimental design has more than one purposefully created group, a commonly measured...
14.3K
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

299
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...
299
Factorial Design02:01

Factorial Design

13.3K
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...
13.3K
Behavioral Genetics and Its Designs01:23

Behavioral Genetics and Its Designs

538
Behavior genetics explores how genetic inheritance influences human behavior. It focuses on how genes, passed from parents to offspring, contribute to the development of behavioral traits and tendencies. This branch of genetics seeks to understand the complex interplay between inherited genetic factors and environmental influences in shaping our behaviors.
The primary methodologies used in behavior genetics include family studies, twin studies, and adoption studies, each providing unique...
538
Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

801
Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
801

You might also read

Related Articles

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

Sort by
Same author

Redox-Active Doubly Boron-Doped Indenofluorenes: Isomer-Directed Access to Open- and Closed-Shell Electronic States Induces Strong Near-Infrared Activity.

Journal of the American Chemical Society·2026
Same author

Yttrium-90 radioembolization treatment of metastatic thyroid carcinoma to the liver: a 3-case series.

JCEM case reports·2026
Same author

Through-space donor-acceptor homoconjugation strategies for emissive radical species.

Chemical science·2026
Same author

Post-synthetic modification strategy for constructing dual-emission fluorescent sensor toward visual detection and quantification of 3-nitrotyrosine biomarker.

Analytica chimica acta·2026
Same author

Error Detection in Emergency Radiology Reports Using a Large Language Model: Multistage Evaluation Study.

Journal of medical Internet research·2026
Same author

Dietary ginsenosides for longevity: from biosynthesis and bioactive potential to functional food applications.

Critical reviews in food science and nutrition·2026
Same journal

Are older adult research participants representative of the general population? Results from 19 clinical studies at one academic research center.

Contemporary clinical trials·2026
Same journal

Multi-site feasibility of a web-based and telephone navigation intervention to connect lung cancer caregivers in community oncology settings with resources: Protocol for the WF-2301CD caregiver oncology needs evaluation tool (CONNECT) trial.

Contemporary clinical trials·2026
Same journal

Rationale and design of a CArdiac rehabilitation program on the prevention of CardioTOXicity in breast Cancer patients undergoing treatment with anthracyclines and/or trastuzumab (CARPTOX-BC) trial: A randomized, active control group, open-label trial.

Contemporary clinical trials·2026
Same journal

Evaluating clinical outcomes of using Undermyfork mobile app with Dexcom G7: Protocol for CGM-Undermyfork randomized controlled trial.

Contemporary clinical trials·2026
Same journal

Outcomes of dyadic recruitment in the promoting re-engagement in meaningful activity (PRIMA) trial.

Contemporary clinical trials·2026
Same journal

Overview of the linking exercise for advancing daily stress (LEADS) management and resilience randomized controlled trial in African American families.

Contemporary clinical trials·2026
See all related articles

Related Experiment Video

Updated: Sep 17, 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

16.6K

Software for complex group sequential designs.

Yujie Zhao1, Keaven Anderson1

  • 1Merck & Co., Inc., Rahway, NJ, USA.

Contemporary Clinical Trials
|July 2, 2025
PubMed
Summary
This summary is machine-generated.

Group sequential designs (GSD) allow early stopping of clinical trials using interim analyses. This study introduces R packages, gsDesign2 and simtrial, to handle complex GSD calculations for varying treatment effects.

Keywords:
Clinical trialsGroup sequential designR packages

More Related Videos

Analyzing Multifactorial RNA-Seq Experiments with DiCoExpress
05:22

Analyzing Multifactorial RNA-Seq Experiments with DiCoExpress

Published on: July 29, 2022

3.7K
Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
05:53

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Published on: June 21, 2018

10.2K

Related Experiment Videos

Last Updated: Sep 17, 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

16.6K
Analyzing Multifactorial RNA-Seq Experiments with DiCoExpress
05:22

Analyzing Multifactorial RNA-Seq Experiments with DiCoExpress

Published on: July 29, 2022

3.7K
Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
05:53

Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry

Published on: June 21, 2018

10.2K

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Software

Background:

  • Group sequential design (GSD) is a statistical methodology for clinical trials, enabling interim analyses (IA) and early termination.
  • GSD enhances decision-making and expedites the development of effective treatments.
  • Recent GSD implementations face increasing complexity, with treatment effects varying over time and strata.

Purpose of the Study:

  • To introduce R packages for group sequential designs.
  • To demonstrate the utility of these packages using examples and simulations.
  • To address the computational challenges in complex GSD scenarios.

Main Methods:

  • Introduction of R packages gsDesign2 and simtrial.
  • Application of packages through illustrative examples.
  • Validation via simulation studies.

Main Results:

  • The R packages gsDesign2 and simtrial provide robust tools for GSD calculations.
  • Demonstrated ability to handle complex GSD scenarios, including time- and strata-varying treatment effects.
  • Facilitated efficient and accurate statistical analysis for advanced clinical trial designs.

Conclusions:

  • gsDesign2 and simtrial are valuable resources for researchers implementing complex group sequential designs.
  • These R packages simplify the computational aspects of GSD, supporting rigorous clinical trial conduct.
  • The use of appropriate software is crucial for the successful application of advanced statistical methodologies in clinical research.