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

Precipitation Titration: Endpoint Detection Methods01:19

Precipitation Titration: Endpoint Detection Methods

6.0K
In argentometric precipitation titrations, endpoints can be detected visually by the Mohr, Volhard, and Fajans methods. In the Mohr method, adding a soluble chromate indicator gives an initial yellow color to the analyte solution. As the titrant is added, the first excess of silver ions forms a red silver chromate precipitate, marking the endpoint. The solution pH should be maintained at about 8 by adding solid CaCO3.
In the Volhard method, a standard excess of AgNO3 is first added to the...
6.0K
Group Design02:01

Group Design

10.7K
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...
10.7K
Factorial Design02:01

Factorial Design

14.1K
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...
14.1K
Stages of Infection01:26

Stages of Infection

65.5K
Stages of infection describe what happens to a susceptible host once a pathogen invades the human body. The stages of infection are incubation, prodromal, illness, stage of decline, and convalescence. The incubation stage is the period from exposure to a pathogen until symptoms start. The infected person is unaware of impending illness as the pathogens grow and multiply within the body. The duration may vary depending on the type of infection. The incubation period of measles averages ten to...
65.5K
Stages of Sleep01:22

Stages of Sleep

1.5K
Sleep progresses through distinct stages, each characterized by specific brain wave patterns and physiological responses ranging from wakefulness to stages of non-rapid eye movement, known as non-REM, to rapid eye movement, referred to as REM. Understanding these stages helps in recognizing how sleep supports various bodily and cognitive functions.
Before sleep begins, in wakefulness, the brain exhibits primarily beta waves, which are high in frequency and low in amplitude, indicating alertness...
1.5K
Stages of General Anesthesia01:22

Stages of General Anesthesia

1.8K
Various sedation levels offer significant advantages in facilitating procedural interventions for patients undergoing medical or invasive surgical procedures. These levels span from anxiolysis to general anesthesia, providing a spectrum of sedative effects to cater to specific patient needs. Anxiolysis reduces anxiety and is achieved through minimal sedation, enabling patients to remain awake and responsive while feeling more at ease during the procedure. This level can benefit minor...
1.8K

You might also read

Related Articles

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

Sort by
Same author

Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin Combined With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive, Early-Stage Breast Cancer.

Clinical breast cancer·2015
Same author

Phase 2 study of eribulin mesylate as first-line therapy for locally recurrent or metastatic human epidermal growth factor receptor 2-negative breast cancer.

Breast cancer research and treatment·2014
Same author

A two-stage patient enrichment adaptive design in phase II oncology trials.

Contemporary clinical trials·2013
Same author

Clinical trial design for mild-to-moderate community-acquired pneumonia--an industry perspective.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America·2008
Same author

Inference methods for saturated models in longitudinal clinical trials with incomplete binary data.

Pharmaceutical statistics·2006
Same author

Diagnostic criteria for postconcussional syndrome after mild to moderate traumatic brain injury.

The Journal of neuropsychiatry and clinical neurosciences·2005
Same journal

Prehabilitation in lung cancer patients undergoing lung resection surgery (Fit4LungNeo): study protocol.

Contemporary clinical trials communications·2026
Same journal

Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial.

Contemporary clinical trials communications·2026
Same journal

Implementation science and the clinical trial workforce: A national needs assessment of training and practice.

Contemporary clinical trials communications·2026
Same journal

Understanding recruitment challenges in Swiss oncology trials: Patient voices from focus groups.

Contemporary clinical trials communications·2026
Same journal

Effectiveness of couple-based maternity education on husbands' involvement in maternity continuum of care service utilization in rural communities of Central Ethiopia: Protocol of cluster randomized controlled trial.

Contemporary clinical trials communications·2026
Same journal

The design of a small Bayesian hybrid-controlled trial utilizing time-to-event data from six published sources that used best alternative care to treat liver-predominant metastasis from primary ocular melanoma.

Contemporary clinical trials communications·2026
See all related articles

Related Experiment Video

Updated: Feb 10, 2026

Primary Neuronal Cultures from the Brains of Late Stage Drosophila Pupae
15:12

Primary Neuronal Cultures from the Brains of Late Stage Drosophila Pupae

Published on: May 28, 2007

15.7K

A two-stage design with two co-primary endpoints.

James X Song1

  • 1100 Tice Blvd, Woodcliff Lake, NJ 07677, USA.

Contemporary Clinical Trials Communications
|May 9, 2018
PubMed
Summary
This summary is machine-generated.

This study introduces a new two-stage clinical trial design for oncology, extending Simon

Keywords:
Co-primary endpointsPhase II oncology trialsTwo-stage design

More Related Videos

Important Endpoints and Proliferative Markers to Assess Small Intestinal Injury and Adaptation using a Mouse Model of Chemotherapy-Induced Mucositis
07:05

Important Endpoints and Proliferative Markers to Assess Small Intestinal Injury and Adaptation using a Mouse Model of Chemotherapy-Induced Mucositis

Published on: May 12, 2019

6.6K
Visualizing the Early Stages of Phagocytosis
08:04

Visualizing the Early Stages of Phagocytosis

Published on: February 3, 2017

17.3K

Related Experiment Videos

Last Updated: Feb 10, 2026

Primary Neuronal Cultures from the Brains of Late Stage Drosophila Pupae
15:12

Primary Neuronal Cultures from the Brains of Late Stage Drosophila Pupae

Published on: May 28, 2007

15.7K
Important Endpoints and Proliferative Markers to Assess Small Intestinal Injury and Adaptation using a Mouse Model of Chemotherapy-Induced Mucositis
07:05

Important Endpoints and Proliferative Markers to Assess Small Intestinal Injury and Adaptation using a Mouse Model of Chemotherapy-Induced Mucositis

Published on: May 12, 2019

6.6K
Visualizing the Early Stages of Phagocytosis
08:04

Visualizing the Early Stages of Phagocytosis

Published on: February 3, 2017

17.3K

Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Oncology Drug Development

Background:

  • Two-stage designs are standard in phase II oncology trials to avoid ineffective drugs.
  • Current designs typically focus on a single efficacy endpoint, often response rate.
  • Controlling Type I and II errors is crucial when multiple endpoints are involved.

Purpose of the Study:

  • To propose a method for extending two-stage oncology trial designs to accommodate two co-primary efficacy endpoints.
  • To develop a simultaneous search for stopping boundaries that control overall Type I (α) and Type II (β) errors.
  • To provide a framework for selecting optimal designs based on objective functions.

Main Methods:

  • Utilizing binomial distribution to define stopping boundaries for two hypotheses.
  • Simultaneously searching for boundaries that satisfy predefined α and β error constraints.
  • Employing simulation studies to validate the proposed methodology and design characteristics.
  • Illustrating the application with a metastatic breast cancer trial example incorporating response rate and quality of life.

Main Results:

  • A novel method for designing two-stage oncology trials with two co-primary endpoints was developed.
  • The method allows for simultaneous optimization of stopping rules while controlling overall error rates.
  • Simulation results confirm the validity and efficiency of the proposed approach.

Conclusions:

  • The proposed design is a practical extension of the Simon Two-Stage Design for phase II oncology trials.
  • This methodology is suitable for trials with two independent co-primary efficacy endpoints.
  • The approach facilitates more robust trial designs when multiple efficacy measures are critical.