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

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

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...

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...

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.

Measurement of Bioavailability: Pharmacodynamic Methods

Measurement of Bioavailability: Pharmacodynamic Methods

Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.

You might also read

Related Articles

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

Sort by

Same author

Conceptualising the experience of having TB: a global qualitative study.

IJTLD open·2026

Same author

Testing a 5-fraction Simultaneous Integrated Boost in Radiotherapy for Breast Cancer: The UK FAST-Forward Boost Trial Opens to Recruitment.

Clinical oncology (Royal College of Radiologists (Great Britain))·2025

Same author

Traceability and comparability through crosswalks with the NeuroMET Memory Metric.

Scientific reports·2023

Same author

Proton Beam Therapy in Breast Cancer Patients: The UK PARABLE Trial is Recruiting.

Clinical oncology (Royal College of Radiologists (Great Britain))·2023

Same author

Results of the c-TRAK TN trial: a clinical trial utilising ctDNA mutation tracking to detect molecular residual disease and trigger intervention in patients with moderate- and high-risk early-stage triple-negative breast cancer.

Annals of oncology : official journal of the European Society for Medical Oncology·2022

Same author

Five-fraction Radiotherapy for Breast Cancer: FAST-Forward to Implementation.

Clinical oncology (Royal College of Radiologists (Great Britain))·2021

Same journal

Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial.

Contemporary clinical trials communications·2026

Same journal

Implementation science and the clinical trial workforce: A national needs assessment of training and practice.

Contemporary clinical trials communications·2026

Same journal

Understanding recruitment challenges in Swiss oncology trials: Patient voices from focus groups.

Contemporary clinical trials communications·2026

Same journal

Effectiveness of couple-based maternity education on husbands' involvement in maternity continuum of care service utilization in rural communities of Central Ethiopia: Protocol of cluster randomized controlled trial.

Contemporary clinical trials communications·2026

Same journal

The design of a small Bayesian hybrid-controlled trial utilizing time-to-event data from six published sources that used best alternative care to treat liver-predominant metastasis from primary ocular melanoma.

Contemporary clinical trials communications·2026

Same journal

A family navigator model for foster parents to promote youth mental health wellness: Study development and protocol.

Contemporary clinical trials communications·2026

See all related articles

Search research articles

Related Experiment Video

Updated: Jan 2, 2026

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

Biomarker-guided trials: Challenges in practice.

M Antoniou¹, R Kolamunnage-Dona¹, J Wason²

¹University of Liverpool, UK.

Contemporary Clinical Trials Communications

|December 3, 2019

Summary

This summary is machine-generated.

Biomarker-guided clinical trials improve treatment benefits and drug development. Addressing practical challenges in funding, ethics, and data is crucial for advancing personalized medicine.

Keywords:

Biomarker Challenges Clinical trial Personalised medicine

More Related Videos

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Published on: January 28, 2014

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Published on: October 11, 2018

Related Experiment Videos

Last Updated: Jan 2, 2026

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

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies

Published on: January 28, 2014

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances

Published on: October 11, 2018

Area of Science:

Clinical Trials Methodology
Personalized Medicine
Biomarker Research

Background:

Biomarker-guided trials are increasingly important for optimizing treatment efficacy and drug development.
These trials aim to improve the benefit-risk ratio of medical interventions.
Numerous trial designs exist, with many already implemented in clinical practice.

Purpose of the Study:

To identify and discuss practical challenges encountered during the implementation of biomarker-guided trials.
To consolidate insights from experts reflecting on completed and ongoing biomarker-guided studies.

Main Methods:

A workshop was organized by the MRC Hubs for Trials Methodology Research Network's Stratified Medicine Working Group.
Participants shared experiences and reflections from real-world biomarker-guided trials.
Discussions focused on identifying practical hurdles in trial execution.

Main Results:

Key challenges identified include issues with funding, ethical and regulatory approvals, patient recruitment, and sample/laboratory monitoring.
Difficulties in biomarker assessment and data sharing/resource management were also highlighted.
Despite complexities, the consensus was that these trials are vital for progress.

Conclusions:

Biomarker-guided trials are essential for the advancement of personalized medicine.
Acknowledging and actively addressing the identified practical challenges is necessary for successful implementation.
Continued efforts are needed to overcome barriers in conducting these complex trials.