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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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...
Crossover Experiments01:16

Crossover Experiments

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.
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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Related Experiment Video

Updated: Jul 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Balanced two-stage designs for phase II clinical trials.

Fei Ye1, Yu Shyr

  • 1Division of Cancer Biostatistics, Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.

Clinical Trials (London, England)
|October 19, 2007
PubMed
Summary

This study introduces a balanced two-stage phase II oncology trial design. It offers comparable sample sizes to Simon

Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Oncology Research

Background:

  • Traditional Simon's two-stage designs for phase II oncology trials assume independent observations and can result in unequal sample sizes between stages.
  • A need exists for phase II trial designs that balance sample sizes across stages, particularly when dealing with correlated observations.
  • Unequal sample sizes in Simon's designs may not be optimal in all clinical trial scenarios.

Purpose of the Study:

  • To develop a novel two-stage phase II clinical trial design that balances sample sizes between the first and second stages.
  • To ensure the proposed balanced design maintains control over type I and type II error rates.
  • To provide an alternative to existing designs for oncology phase II trials.

Main Methods:

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Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies

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Last Updated: Jul 10, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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  • Simulated two-stage designs using various response rates, null/alternative hypotheses, and type I/II error constraints.
  • Incorporated correlated data by adopting Sargent's method to account for intra-person correlation.
  • Generated design characteristics for independent and correlated data scenarios.

    • Main Results:

    • Developed a balanced two-stage design method applicable to both independent and correlated observations.
    • Compared the characteristics of the balanced design with Simon's optimal and minimax designs.
    • Demonstrated that the balanced design yields comparable total sample sizes to Simon's designs.

    Conclusions:

    • The balanced two-stage design offers a valuable alternative for phase II oncology trials, especially when monitoring near the study's midpoint is desired.
    • For correlated data, the developed designs were specifically produced for scenarios where half the participants have one observation and the other half have two.
    • The degree of intra-person correlation was evaluated at three distinct levels in the correlated data analysis.