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

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...

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, controlled...

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...

Hazard Ratio

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...

Comparing the Survival Analysis of Two or More Groups

Comparing the Survival Analysis of Two or More Groups

Survival analysis is a cornerstone of medical research, used to evaluate the time until an event of interest occurs, such as death, disease recurrence, or recovery. Unlike standard statistical methods, survival analysis is particularly adept at handling censored data—instances where the event has not occurred for some participants by the end of the study or remains unobserved. To address these unique challenges, specialized techniques like the Kaplan-Meier estimator, log-rank test, and Cox...

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.

You might also read

Related Articles

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

Sort by

Same author

Sotatercept reduces bone morphogenetic protein signaling in patients with pulmonary arterial hypertension.

Science translational medicine·2026

Same author

The Effect of an Educational Intervention on the Knowledge and Self-Care Skills of Adult Patients With Venous Leg Ulcers: Protocol for a Randomized Controlled Trial.

JMIR research protocols·2026

Same author

A burn-in(g) question: How long should an initial equal randomization stage be before Bayesian response-adaptive randomization?

Statistical methods in medical research·2026

Same author

Drug Development for Pulmonary Arterial Hypertension: Unleashing the Potential of Single-Patient Studies Using Continuous Monitoring.

Pulmonary circulation·2025

Same author

Implementing response-adaptive randomisation in stratified rare-disease trials: Design challenges and practical solutions.

Statistical methods in medical research·2025

Same author

Revisiting optimal allocations for binary responses: insights from considering type-I error rate control.

Biometrics·2025

Search research articles

Related Experiment Video

Updated: May 27, 2026

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

Safety-Driven Response Adaptive Randomization: An Application in Noninferiority Oncology Trials.

Maria Vittoria Chiaruttini¹, Lukas Pin², Sofía S Villar²

¹Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy.

Statistics in Medicine

|May 26, 2026

Summary

This study introduces SAFER, a new response-adaptive randomization (RAR) design using safety data for treatment allocation in oncology trials. SAFER improves patient safety while maintaining statistical power, especially in noninferiority studies.

Keywords:

FDA Project Optimus adverse events efficacy endpoints association patient‐benefit toxicity

More Related Videos

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

Related Experiment Videos

Last Updated: May 27, 2026

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

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Inverse Probability of Treatment Weighting (Propensity Score) using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

Area of Science:

Clinical Trials Methodology
Biostatistics
Oncology Research

Background:

Response-adaptive randomization (RAR) typically uses efficacy data for patient allocation.
Efficacy outcomes like survival often have delays, limiting traditional RAR applicability.
Prioritizing patient safety is crucial, especially in oncology trials.

Purpose of the Study:

Introduce SAFER, a novel RAR design using early safety data for treatment allocation.
Address the limitations of efficacy-based RAR in trials with delayed outcomes.
Balance statistical efficiency with safety-driven adaptations in noninferiority trials.

Main Methods:

Developed the SAFER (Safety-Adaptive Flexible Efficacy Response) design.
Leveraged early-emerging safety data to dynamically adjust patient allocation.
Simulated the SAFER design using data inspired by the CAPP-IT Phase III oncology trial.

Main Results:

SAFER preserves statistical power for efficacy endpoints.
The design effectively reduces the overall adverse event rate.
SAFER demonstrates flexible adaptation speed based on endpoint timing.

Conclusions:

SAFER offers a viable solution for RAR in settings with delayed efficacy outcomes.
The design is particularly beneficial for oncology noninferiority trials.
SAFER enhances patient safety without compromising trial statistical integrity.