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 Trials: Overview01:11

Clinical Trials: Overview

4.7K
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...
4.7K
Clinical Trials01:16

Clinical Trials

8.5K
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...
8.5K
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

1.6K
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.6K
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

413
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...
413
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

595
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...
595
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.7K
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...
4.7K

You might also read

Related Articles

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

Sort by
Same author

Assessing the risk of diabetic retinopathy progression with GLP-1 receptor agonists: a systematic review and meta-analysis.

BMC ophthalmology·2026
Same author

CTSS regulates macrophage lipid metabolic reprogramming and white matter repair after intracerebral hemorrhage.

Journal of translational medicine·2026
Same author

From Gold to Polymer: Latex Bead-Assisted CRISPR-Cas12a Platform for Next-Generation Protein Diagnostics.

ACS measurement science au·2026
Same author

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

Pharmaceutical statistics·2026
Same author

Complete ureteral duplication with occult calculi: A case report.

Experimental and therapeutic medicine·2026
Same author

A randomized controlled Phase I de-escalation trial of molnupiravir and nirmatrelvir/ritonavir combination for mild-moderate SARS-CoV-2 infection.

The Journal of antimicrobial chemotherapy·2026
Same journal

Assessing Financial Toxicity in Cancer: A Global Systematic Review and Meta-Analysis Using an Asset Framework.

Cancer medicine·2026
Same journal

Years of Life Lost of Patients With Early Adenocarcinoma of the Esophagogastric Junction Compared to Esophageal or Gastric Adenocarcinoma. A Registry-Based Study.

Cancer medicine·2026
Same journal

Elevation of Eosinophil Proportion After Pembrolizumab Increases the Risk of Immune-Related Adverse Events in Patients With Bladder Cancer.

Cancer medicine·2026
Same journal

Cholesterol-Lowering Treatment Blocks Epithelial-Mesenchymal Transition (EMT) Associated Invasiveness and Drug Resistance in Breast and Colorectal Adenocarcinoma Models.

Cancer medicine·2026
Same journal

Factors Associated With Optimal Patient-Clinician Communication Among Cancer Survivors.

Cancer medicine·2026
Same journal

Targeting Temozolomide-Resistant Glioblastoma: Therapeutic Potential of Neuronal Nitric Oxide Synthase Inhibitor.

Cancer medicine·2026
See all related articles

Related Experiment Video

Updated: Apr 25, 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

10.1K

Modern Clinical Trials: Seamless Designs and Master Protocols.

Abigail Burdon1, Thomas Jaki1,2, Xijin Chen1

  • 1MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.

Cancer Medicine
|April 24, 2026
PubMed
Summary
This summary is machine-generated.

Seamless clinical trials and master protocols accelerate cancer drug development. These innovative approaches streamline testing, helping patients access life-saving treatments faster by improving efficiency in Phase II/III trials.

Keywords:
adaptive designsefficient trialsinterim analysismaster protocolsseamless phase II/III

More Related Videos

In Silico Clinical Trials for Cardiovascular Disease
09:09

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

2.1K
Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
13:24

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

Published on: April 11, 2016

14.0K

Related Experiment Videos

Last Updated: Apr 25, 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

10.1K
In Silico Clinical Trials for Cardiovascular Disease
09:09

In Silico Clinical Trials for Cardiovascular Disease

Published on: May 27, 2022

2.1K
Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
13:24

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies

Published on: April 11, 2016

14.0K

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Drug Development

Background:

  • Drug development is lengthy and costly, especially for cancer Phase II/III trials, leading to high failure rates.
  • Challenges in cancer drug development necessitate streamlined approaches.
  • Seamless clinical trials and master protocols offer solutions to improve efficiency.

Purpose of the Study:

  • To explore the advantages of seamless clinical trials and master protocols.
  • To highlight principles contributing to the success of these innovative trial designs.
  • To acknowledge regulatory considerations and challenges associated with these methods.

Main Methods:

  • Seamless clinical trials allow for fluid transitions between trial phases, accelerating promising therapy development.
  • Master protocols provide a structured framework for investigating multiple treatments and patient subgroups within a single trial.
  • Real-world trial examples are used to illustrate the application and benefits of these methodologies.

Main Results:

  • Discussion of advantages through real trial examples.
  • Identification of key principles for successful implementation.
  • Acknowledgement of regulatory aspects and potential hurdles.

Conclusions:

  • Seamless designs and master protocols can significantly enhance confirmatory clinical trials.
  • These innovative approaches hold the potential to expedite patient access to life-saving cancer treatments.
  • Improved efficiency in cancer drug development is a key outcome.