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...

Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

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...

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...

Randomized Experiments

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...

You might also read

Related Articles

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

Sort by

Same author

Hidden diagnoses among patients with double seronegative myasthenia gravis.

Frontiers in neurology·2026

Same author

Elevated C1s/C1-INH in serum and plasma of myasthenia gravis patients.

Journal of neuroimmunology·2024

Same author

Developing a novel device based on a new technology for non-invasive measurement of blood biomarkers irrespective of skin color.

German medical science : GMS e-journal·2023

Same author

Visualization and Quantification of Post-stroke Neural Connectivity and Neuroinflammation Using Serial Two-Photon Tomography in the Whole Mouse Brain.

Frontiers in neuroscience·2019

Same author

Transfusing maternal blood to her newborn baby-irrespective of ABO mismatch.

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·2019

Same author

The Emerging Role of Inhaled Heroin in the Opioid Epidemic: A Review.

JAMA neurology·2018

Same journal

Abrocitinib as a Novel Therapeutic Option for Elastolytic Giant Cell Granuloma: A Case Report.

American journal of therapeutics·2026

Same journal

Dupilumab for Lichen Amyloidosis in an Elderly Multimorbid Patient.

American journal of therapeutics·2026

Same journal

Deucravacitinib for Generalized Pustular Psoriasis and Comorbid Polymyositis: Dual Efficacy and Favorable Safety.

American journal of therapeutics·2026

Same journal

Repurposed Drugs and Cardiovascular Morbidity: A Cost-Effectiveness Analysis.

American journal of therapeutics·2026

Same journal

Do Not Treat a Sequencing Report: Therapeutic Stewardship in Endometrial Microbiome Testing.

American journal of therapeutics·2026

Same journal

Right Side Accessory Pathway Mediated Cardiomyopathy Treated with Amiodarone: First Adult Case Report.

American journal of therapeutics·2026

See all related articles

Search research articles

Related Experiment Video

Updated: May 10, 2026

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

Shuffling Adaptive Clinical Trials.

Sanjay G Gokhale¹, Sankalp Gokhale

¹1Department of Pediatrics and Neonatology, Rajhans Hospital, Saphale, India; and 2Department of Neurology, Duke University, Durham, NC.

American Journal of Therapeutics

|June 12, 2013

Summary

This summary is machine-generated.

This study introduces a novel shuffling adaptive trial design for drug development. This method uses real-time data to improve trial efficiency and ensure patient population relevance without statistical modifications.

More Related Videos

Computerized Adaptive Testing System of Functional Assessment of Stroke

Computerized Adaptive Testing System of Functional Assessment of Stroke

Published on: January 7, 2019

Related Experiment Videos

Last Updated: May 10, 2026

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability

Published on: October 7, 2017

Computerized Adaptive Testing System of Functional Assessment of Stroke

Computerized Adaptive Testing System of Functional Assessment of Stroke

Published on: January 7, 2019

Area of Science:

Clinical research methodology
Pharmaceutical development
Biostatistics

Background:

Clinical trials are crucial for evaluating new medical technologies, but rising development costs and decreasing regulatory approvals necessitate innovative approaches.
Adaptive clinical trial designs offer improved efficiency and success rates by allowing mid-study modifications.

Purpose of the Study:

To propose a novel adaptive clinical trial design, the shuffling adaptive trial, that addresses limitations of existing methods.
To enhance the efficiency and integrity of clinical trials through real-time data utilization.

Main Methods:

Development of a mathematical model for a shuffling adaptive trial design.
Integration of real-time data analysis to minimize the gap between expected and observed data.
Elimination of the need for statistical modifications by aligning data collection with analysis.

Main Results:

The proposed shuffling adaptive trial design utilizes real-time data, eliminating the need for statistical modifications.
This approach ensures the patient population remains consistent with the original target population throughout the trial.
The design yields clinically relevant results by maintaining trial integrity and efficiency.

Conclusions:

The shuffling adaptive trial design offers a promising advancement in clinical trial methodology.
This innovative approach can improve drug development efficiency and success rates.
Real-time data integration in adaptive trials ensures validity and clinical relevance.