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

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.
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...
Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis00:59

Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis

Noncompartmental analyses offer an alternative method for describing drug pharmacokinetics without relying on a specific compartmental model. In this approach, the drug's pharmacokinetics are assumed to be linear, with the terminal phase log-linear. This assumption allows for simplified analysis and interpretation of the drug's behavior in the body.
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This relationship...
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...

You might also read

Related Articles

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

Sort by
Same author

Rituximab, Acalabrutinib, and Durvalumab for Primary Central Nervous System Lymphoma: A Single-arm, Phase 1b, Multi-center Study.

Clinical cancer research : an official journal of the American Association for Cancer Research·2026
Same author

A nomogram for predicting recurrence-free survival in patients with high-risk GIST receiving adjuvant imatinib: A nationwide registry study.

Experimental and therapeutic medicine·2026
Same author

Identifying expression and DNA methylation biomarkers for lung adenocarcinoma risk in East Asia.

Journal of the National Cancer Institute·2026
Same author

SLOG versus modified FOLFIRINOX as first-line treatment for advanced pancreatic cancer: A randomized phase II trial (TCOG T5217).

European journal of cancer (Oxford, England : 1990)·2026
Same author

Stratifying lung adenocarcinoma risk with multi-ancestry polygenic risk scores in East Asian never-smokers.

Journal of the National Cancer Institute·2025
Same author

Nivolumab plus ipilimumab for potentially resectable hepatocellular carcinoma: Long-term efficacy and biomarker exploration.

Journal of hepatology·2025
Same journal

Impact of Information Leakage in Platform Trials With Survival Endpoints on Type I Error Control.

Pharmaceutical statistics·2026
Same journal

Harmonic Fowlkes-Mallows Index for Medical Diagnostics Tests and Optimal Cut-Off Point Selection of Binary Diseases.

Pharmaceutical statistics·2026
Same journal

Early Phase Dose-Finding Designs for CAR-T Cell Therapies.

Pharmaceutical statistics·2026
Same journal

Optimizing Randomization Ratios in Clinical Trials With Survival Endpoints.

Pharmaceutical statistics·2026
Same journal

CUI-MET: A Clinical Utility Index Based Analysis and Decision Framework for Dose Optimization in Multiple-Dose, Multiple-Outcome Randomized Trials.

Pharmaceutical statistics·2026
Same journal

Will the Pharmaceutical Industry Need Statisticians in an AI World?

Pharmaceutical statistics·2026
See all related articles

Related Experiment Video

Updated: Jun 15, 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

An alternative phase II/III design for continuous endpoints.

Wong-Shian Huang1, Jen-pei Liu, Chin-Fu Hsiao

  • 1Institute of Statistics, National Chiao Tung University, Hsinchu, Taiwan.

Pharmaceutical Statistics
|February 27, 2010
PubMed
Summary
This summary is machine-generated.

This study introduces a novel adaptive phase II/III clinical trial design to improve drug development success rates. The proposed method reduces sample sizes and trial duration by integrating dose selection and confirmation stages.

More Related Videos

Cutoff Value of Phase Angle by Bioelectrical Impedance Analysis at Admission as a Prognostic Factor in Patients with Acute Heart Failure
05:16

Cutoff Value of Phase Angle by Bioelectrical Impedance Analysis at Admission as a Prognostic Factor in Patients with Acute Heart Failure

Published on: June 10, 2025

Related Experiment Videos

Last Updated: Jun 15, 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

Cutoff Value of Phase Angle by Bioelectrical Impedance Analysis at Admission as a Prognostic Factor in Patients with Acute Heart Failure
05:16

Cutoff Value of Phase Angle by Bioelectrical Impedance Analysis at Admission as a Prognostic Factor in Patients with Acute Heart Failure

Published on: June 10, 2025

Area of Science:

  • Clinical Trials
  • Pharmaceutical Development
  • Biostatistics

Background:

  • Declining success rates in drug development necessitate innovative methodologies.
  • Current drug development paradigms are insufficient, requiring strategies to minimize sample sizes and shorten timelines.

Purpose of the Study:

  • To propose an alternative, adaptive phase II/III clinical trial design.
  • To enhance drug development efficiency by reducing sample size and trial duration.
  • To improve the overall success rate of drug development.

Main Methods:

  • A two-stage adaptive design incorporating a selection stage and a confirmation stage.
  • Utilizes continuous efficacy endpoints with a randomized parallel design for dose selection.
  • Integrates cumulative data analysis across both stages while controlling Type I and II error rates.

Main Results:

  • The proposed adaptive design allows for determination of sample sizes and critical values at each stage.
  • Demonstrates potential for reducing overall sample size compared to traditional designs.
  • Offers a method to improve the success rate of drug development.

Conclusions:

  • The adaptive phase II/III design offers a promising alternative to traditional drug development approaches.
  • This methodology can lead to more efficient and successful drug development processes.
  • The design provides a framework for optimizing clinical trial efficiency and outcomes.