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

Clinical Trials01:16

Clinical Trials

10.2K
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...
10.2K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.6K
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...
4.6K
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

217
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
217
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

187
Body: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...
187
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

270
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...
270
Crossover Experiments01:16

Crossover Experiments

4.5K
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.
4.5K

You might also read

Related Articles

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

Sort by
Same author

Comparing Methods to Assess Treatment Effect Heterogeneity in General Parametric Regression Models.

Statistics in medicine·2026
Same author

Clinical Diagnostics After Failed Hearing Screening in People With Intellectual Disabilities Do Not Often Take Place.

Journal of intellectual disability research : JIDR·2026
Same author

Using Individualized Treatment Effects to Assess Treatment Effect Heterogeneity.

Statistics in medicine·2025
Same author

Informative simultaneous confidence intervals for graphical test procedures.

Statistical methods in medical research·2025
Same author

Evaluating Causal Effects on Time-to-Event Outcomes in an RCT in Oncology With Treatment Discontinuation.

Biometrical journal. Biometrische Zeitschrift·2025
Same author

ADDIS-Graphs for Online Error Control With Application to Platform Trials.

Biometrical journal. Biometrische Zeitschrift·2025
Same journal

A comparison of methods for designing hybrid type 2 cluster-randomized trials with continuous effectiveness and implementation endpoints.

Statistical methods in medical research·2026
Same journal

Joint analysis of longitudinal and recurrent event data: A functional regression approach with autoregressive frailty.

Statistical methods in medical research·2026
Same journal

Empirical likelihood inference for the area under the receiver operating characteristic (ROC) curve with verification biased data.

Statistical methods in medical research·2026
Same journal

Maximum likelihood estimation in proportional odds regression model based on interval-censored event-time data.

Statistical methods in medical research·2026
Same journal

A bounded hazard ratio Cox model for the effect of time to treatment on mortality.

Statistical methods in medical research·2026
Same journal

Analysis of longitudinal zero-inflated count data using overall marginalized hurdle models.

Statistical methods in medical research·2026
See all related articles

Related Experiment Video

Updated: Jan 19, 2026

Diagonal Method to Measure Synergy Among Any Number of Drugs
12:08

Diagonal Method to Measure Synergy Among Any Number of Drugs

Published on: June 21, 2018

19.5K

Testing multiple dose combinations in clinical trials.

Saswati Saha1, Werner Brannath1, Björn Bornkamp2

  • 1Competence Centre for Clinical Trials, University of Bremen, Germany.

Statistical Methods in Medical Research
|September 25, 2019
PubMed
Summary
This summary is machine-generated.

New statistical methods offer confirmatory evidence for drug combination therapy effectiveness. These approaches ensure the combination of two drugs is superior to individual doses, controlling for familywise error rate.

Keywords:
Drug combinationfactorial designintersection union testsmultiple testing

More Related Videos

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
07:02

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Published on: February 11, 2019

10.2K
Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

12.7K

Related Experiment Videos

Last Updated: Jan 19, 2026

Diagonal Method to Measure Synergy Among Any Number of Drugs
12:08

Diagonal Method to Measure Synergy Among Any Number of Drugs

Published on: June 21, 2018

19.5K
A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
07:02

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Published on: February 11, 2019

10.2K
Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
15:04

Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation

Published on: January 19, 2019

12.7K

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacology

Background:

  • Drug combination therapies aim for enhanced efficacy by targeting diseases through multiple pathways.
  • Existing statistical methods for comparing fixed-dose combinations to individual components have limitations when extended to multiple dose levels.

Purpose of the Study:

  • To propose and validate novel statistical approaches for confirmatory drug combination trials.
  • To provide familywise error rate control when assessing the superiority of a two-drug combination over individual component doses.

Main Methods:

  • Development of two new statistical approaches for multilevel factorial designs.
  • Utilizing bootstrapping tests and union intersection tests under least favorable null configurations for Type 1 error control.

Main Results:

  • The proposed methods offer simple implementation for confirmatory assurance in drug combination trials.
  • Bootstrap methods showed power advantages but potential error rate inflation in small samples.
  • Simulations and a real-world blood pressure trial demonstrated the approaches' utility.

Conclusions:

  • The novel methods provide a robust framework for evaluating two-drug combination therapies.
  • These approaches facilitate reliable comparisons of combination treatments against monotherapies with controlled statistical error.