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

Crossover Experiments01:16

Crossover Experiments

2.9K
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.
2.9K
Dose-Response Relationship: Potency and Efficacy01:22

Dose-Response Relationship: Potency and Efficacy

4.6K
The potency of a drug is the measure of its ability to produce a biological response and can be compared by looking at the half-maximum effective concentration or EC50 values of different drugs. A lower EC50 value indicates higher potency of the drug. In the dose–response curve of two antihypertensive drugs, candesartan and irbesartan, a significant difference is observed in their EC50 values. A lower EC50 value for candesartan indicates that it is more potent than irbesartan, as it...
4.6K
Comparing the Survival Analysis of Two or More Groups01:20

Comparing the Survival Analysis of Two or More Groups

232
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...
232
Clinical Trials01:16

Clinical Trials

6.9K
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...
6.9K
Clinical Trials: Overview01:11

Clinical Trials: Overview

3.1K
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...
3.1K
Dose-Response Relationship: Selectivity and Specificity01:25

Dose-Response Relationship: Selectivity and Specificity

7.1K
Drugs exert their therapeutic effects by interacting with receptors, enzymes, or ion channels that are present throughout the human body. The strength and duration of the interaction between a drug and its target receptor are characterized by the selectivity and specificity of the drug. Selectivity refers to a drug's strong preference for its intended target over other targets. For instance, isoprenaline, a non-selective β-adrenergic agonist, interacts with both β1- and...
7.1K

You might also read

Related Articles

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

Sort by
Same author

Orientational Switching as an Extra Degree of Freedom in Self-Assembled C<sub>70</sub> and Octanethiol on Au(111).

Langmuir : the ACS journal of surfaces and colloids·2026
Same author

Super-resolution multimodal spatial transcriptomics reveals an ovoid stem cell niche structuring de novo shoot regeneration.

Molecular plant·2026
Same author

Laminar patterning transcription factors orchestrate spatial metabolite partitioning in Capsicum fruit.

Nature plants·2026
Same author

Rationale for incorporating short-term endpoints in interim futility analysis of phase 3 oncology trials: a simulation study.

BMC medical research methodology·2026
Same author

Unnoticed Entry, Noticed Transmission: Epidemiological Insights into China's First clade Ib MPXV cluster.

The Journal of infectious diseases·2026
Same author

Mechanical Strength: An Unrecognised Target in the Genetic Improvement of Crops.

Plant biotechnology journal·2026

Related Experiment Video

Updated: Jul 31, 2025

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction
09:44

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction

Published on: January 29, 2019

10.1K

A comparative study of adaptive trial designs for dose optimization.

Jingyi Zhang1, Xin Chen1, Bosheng Li1

  • 1Research Center of Biostatistics and Computational Pharmacy, China Pharmaceutical University, Nanjing, China.

Pharmaceutical Statistics
|May 8, 2023
PubMed
Summary

Project Optimus aims to improve cancer drug development by moving beyond maximum tolerated dose (MTD) to find the optimal biological dose (OBD). Model-assisted designs are recommended for their ease of use and accuracy in identifying the OBD.

Keywords:
dose optimizationmodel-assisted designsoptimal biological dosephase I-II designsrisk-benefit tradeoff

More Related Videos

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

10.7K
Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform
07:57

Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform

Published on: March 24, 2022

2.8K

Related Experiment Videos

Last Updated: Jul 31, 2025

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction
09:44

Pretargeted Radioimmunotherapy Based on the Inverse Electron Demand Diels-Alder Reaction

Published on: January 29, 2019

10.1K
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

10.7K
Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform
07:57

Positron Emission Tomography-based Dose Painting Radiation Therapy in a Glioblastoma Rat Model using the Small Animal Radiation Research Platform

Published on: March 24, 2022

2.8K

Area of Science:

  • Oncology
  • Clinical Pharmacology
  • Biostatistics

Background:

  • The US FDA's Project Optimus seeks to update oncology drug development paradigms.
  • Current maximum tolerated dose (MTD) methods are insufficient for novel therapies like targeted agents and immunotherapies.
  • Identifying the optimal biological dose (OBD) is crucial for balancing risk and benefit in these treatments.

Approach:

  • Reviewed representative dose optimization designs, including model-based and model-assisted approaches.
  • Compared design operating characteristics using 10,000 simulated scenarios with varied dose-toxicity and dose-efficacy profiles.
  • Evaluated performance across diverse dose-response relationships.

Key Points:

  • Model-assisted designs demonstrated superior ease of implementation compared to model-based designs.
  • Model-assisted methods showed robustness and high accuracy in identifying the optimal biological dose (OBD).
  • Simulation results provide quantitative comparisons of different dose-finding strategies.

Conclusions:

  • Model-assisted dose optimization designs offer practical advantages for oncology trials.
  • Guidance is provided for selecting appropriate dose optimization methods in clinical practice.
  • The findings support the transition towards optimal biological dose determination in cancer drug development.