Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Preclinical Development: Overview

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...

Clinical Trials: Overview

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 Trials

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...

Pharmacogenomics: Identification of New Drug Targets

Pharmacogenomics: Identification of New Drug Targets

Advances in genomics have profoundly influenced drug discovery by increasing both the speed and accuracy of pharmaceutical development. Pharmacogenomics, which examines how genetic variation influences drug response, facilitates the identification of novel therapeutic targets and enables patient stratification for personalized treatment. These strategies contribute to improved drug efficacy, minimized adverse effects, and more efficient clinical trial design.Mapping genetic differences...

Dosage Regimen: Individualization

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...

You might also read

Related Articles

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

Sort by

Same author

Monitoring overall survival in pivotal trials in indolent cancers.

Statistics in biopharmaceutical research·2025

Same author

Ribociclib plus Endocrine Therapy in Early Breast Cancer.

The New England journal of medicine·2024

Same author

Methodology for Good Machine Learning with Multi-Omics Data.

Clinical pharmacology and therapeutics·2023

Same author

Quantitative Assessment of Ribociclib Exposure-Response Relationship to Justify Dose Regimen in Patients with Advanced Breast Cancer.

Journal of clinical pharmacology·2023

Same author

Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy

Therapeutic advances in medical oncology·2023

Same author

Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.

The New England journal of medicine·2022

Search research articles

Related Experiment Video

Updated: Mar 8, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Patient subgroup identification for clinical drug development.

Xin Huang¹, Yan Sun¹, Paul Trow¹

¹AbbVie, Inc., North Chicago, IL, U.S.A.

Statistics in Medicine

|February 2, 2017

Summary

This study introduces methods for creating multivariate biomarker signatures with thresholds to predict clinical outcomes. These signatures aid precision medicine by stratifying patients for tailored therapies.

Keywords:

clinical trial cross-validation cutoff estimation precision medicine predictive modeling predictive significance subgroup identification variable selection

More Related Videos

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Published on: November 22, 2021

Related Experiment Videos

Last Updated: Mar 8, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

Published on: March 20, 2021

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Profiling Sensitivity to Targeted Therapies in EGFR-Mutant NSCLC Patient-Derived Organoids

Published on: November 22, 2021

Area of Science:

Biostatistics
Clinical Trial Design
Translational Medicine

Background:

Understanding biomarker-clinical outcome relationships is crucial for precision medicine.
Current methods often require complex modeling for prognostic and predictive signatures.
Simpler, interpretable signatures are needed for clinical practice.

Purpose of the Study:

To propose methods for developing multivariate biomarker signatures with thresholds.
To enable easier interpretation and implementation of predictive signatures in clinical practice.
To address signatures for continuous, binary, and time-to-event endpoints.

Main Methods:

Development of statistical methods for multivariate biomarker signature creation.
Utilizing thresholds (cutoffs) on individual biomarkers for signature definition.
Application to various clinical endpoint types: continuous, binary, and time-to-event.

Main Results:

Proposed methods demonstrated through simulations.
Case study illustration provided for practical application.
Validation of signature development approaches for clinical utility.

Conclusions:

Multivariate biomarker signatures with thresholds offer a practical approach for precision medicine.
These signatures facilitate patient stratification and tailored therapeutic strategies.
The proposed methods enhance the interpretability and implementation of predictive biomarkers in clinical trials.