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

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...

You might also read

Related Articles

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

Sort by

Same author

Kaempferol-derived carbon dots as antiviral nanomodulators of TLR4 signalling and redox homeostasis in African swine fever virus infection.

Nanoscale·2026

Same author

MGF100 but not MGF300 family is a potential multigene-deleted target for ASFV attenuation and live attenuated vaccine development.

Virulence·2026

Same author

Oral GLP-1 receptor agonist promotes astrocyte-neuron lactate and lipid transfer with neuroprotective effects.

Cell metabolism·2026

Same author

Cefazolin for Methicillin-Susceptible <i>Staphylococcus aureus</i> Bacteremia.

The New England journal of medicine·2026

Same author

Torrefaction of Demineralized Wood with Flue Gas: Kinetics, Product Distribution, and Thermal Conversion.

Polymers·2026

Same author

Remote Monitoring Approaches to Reduce Readmissions After Infection and Sepsis: A Randomized Clinical Trial.

JAMA network open·2026

Search research articles

Related Experiment Video

Updated: Nov 1, 2025

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Published on: September 5, 2025

Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials.

Chengxing Cindy Lu¹, Xiaoyun Nicole Li², Kristine Broglio³

¹Analytics and Data Sciences, Biogen Inc, 300 Binney St, Cambridge, MA, 02142, USA. cindy.lu@biogen.com.

Therapeutic Innovation & Regulatory Science

|June 23, 2021

Summary

This summary is machine-generated.

Master protocols, including basket, umbrella, and platform trials, accelerate drug development. This review clarifies their designs, statistical methods, and operational challenges to promote wider adoption in clinical research.

Keywords:

Adaptive design Basket trial Complex clinical trial Master protocol Platform trial Umbrella trial

More Related Videos

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Profiling of Pre-micro RNAs and microRNAs using Quantitative Real-time PCR qPCR Arrays

Profiling of Pre-micro RNAs and microRNAs using Quantitative Real-time PCR qPCR Arrays

Published on: December 3, 2010

Related Experiment Videos

Last Updated: Nov 1, 2025

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Updated Protocol for the Assembly and Use of the Minibioreactor Array (MBRA)

Published on: September 5, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

Profiling of Pre-micro RNAs and microRNAs using Quantitative Real-time PCR qPCR Arrays

Profiling of Pre-micro RNAs and microRNAs using Quantitative Real-time PCR qPCR Arrays

Published on: December 3, 2010

Area of Science:

Clinical trial design
Drug development
Biostatistics

Background:

Master protocols (basket, umbrella, platform trials) offer innovative frameworks for clinical research.
Despite recognized advantages, their widespread adoption is limited.
Challenges include novel statistical designs, analysis considerations, and operational complexities.

Purpose of the Study:

To provide a comprehensive overview of the master protocol framework.
To unify definitions and present illustrative examples.
To review statistical methodologies for design and analysis.

Main Methods:

Literature review of master protocol designs and statistical approaches.
Discussion of practical considerations for implementation.
Synthesis of recommendations for practitioners.

Main Results:

Master protocols can significantly expedite drug development and improve trial efficiency.
Key statistical methods and analytical considerations are presented.
Practical guidance is offered to address operational challenges.

Conclusions:

Master protocols represent a significant advancement in clinical trial design.
Addressing statistical and operational challenges is crucial for successful implementation.
This work aims to facilitate broader use of master protocols for faster patient access to medicines.