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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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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...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Phase-lead and Phase-lag Controllers01:22

Phase-lead and Phase-lag Controllers

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Understanding the working function of different types of controllers can be illustrated with practical analogies, such as adjusting a stereo's volume equalizer. Cranking up the bass involves a phase-lead controller, which functions as a high-pass filter, while increasing the treble uses a phase-lag controller, which acts as a low-pass filter. PD controllers, similar to high-pass filters, enhance the system's response to high-frequency components. PI controllers, akin to low-pass...
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Statistical Software for Data Analysis and Clinical Trials01:12

Statistical Software for Data Analysis and Clinical Trials

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Statistical software is pivotal in data analysis and clinical trials by providing tools to analyze data, draw conclusions, and make predictions. These software packages range from simple data management applications to complex analytical platforms, supporting various statistical tests, models, and simulation techniques. Their significance lies in their ability to handle vast amounts of data with precision and efficiency, enabling researchers to validate hypotheses, identify trends, and make...
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Muscles that Move the Arm01:31

Muscles that Move the Arm

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Nine muscles are involved in arm movements. Two of these, the pectoralis major and latissimus dorsi, originate from the axial skeleton and are called axial muscles. The other seven originate from the scapula and are called the scapular muscles.
The pectoralis major has two origins. Its clavicular head originates on the medial half of the clavicle. In contrast, the sternocostal head originates on the costal cartilages of ribs 1-6, the sternum, and the aponeurosis of the external oblique of the...
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Time and frequency -Domain Interpretation of Phase-lead Control01:24

Time and frequency -Domain Interpretation of Phase-lead Control

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Phase-lead controllers are commonly used in various control systems to enhance response speed and stability. Adjusting the brightness on a television screen offers a practical example of phase-lead control. When contrast is enhanced, a phase-lead controller is employed. Mathematically, phase-lead control is identified when the first parameter is smaller than the second.
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Related Experiment Video

Updated: Feb 8, 2026

An Objective and Child-friendly Assessment of Arm Function by Using a 3-D Sensor
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Control arm overperformance in phase 3 oncology clinical trials.

Ansel P Nalin1, Pavlos Msaouel2,3, Adam J Grippin1

  • 1Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Cancer
|February 7, 2026
PubMed
Summary

Control arm overperformance is common in phase 3 oncology randomized clinical trials (RCTs), impacting study power. This phenomenon is more prevalent when overall survival (OS) is the primary endpoint, suggesting potential underappreciation of postprogression therapies.

Keywords:
control arm estimatemethodologyoverall survivalphase 3 trialspostprogression therapyprimary end pointtrial design

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Area of Science:

  • Oncology Clinical Trials
  • Biostatistics
  • Meta-epidemiology

Background:

  • Accurate prediction of control arm outcomes is crucial for power calculations and enrollment targets in randomized clinical trials (RCTs).
  • Unexpected overperformance by the control arm can lead to underpowered studies, potentially affecting trial results and conclusions.

Purpose of the Study:

  • To estimate the prevalence of control arm overperformance in phase 3 oncology RCTs.
  • To assess the association between control arm overperformance and trial outcomes.

Main Methods:

  • A meta-epidemiological study was conducted on two-arm, superiority-design, phase 3 oncology RCTs.
  • Data on power calculations, justifications, and outcomes were extracted from publications and protocols.
  • Control arm performance was quantified as the ratio of observed to pretrial estimated outcomes; overperformance was defined as a 10% improvement.

Main Results:

  • Of 385 included RCTs, 43% exhibited overperformance.
  • Overperformance was associated with lower odds of meeting the primary endpoint (aOR, 0.989; P = 0.015).
  • RCTs using overall survival (OS) as the primary endpoint were more likely to show overperformance (56% vs. 33%; aOR, 2.43; P = 0.001).

Conclusions:

  • Control arm overperformance is frequent in phase 3 oncology RCTs and impacts study power.
  • The high prevalence of overperformance in OS-based trials may indicate underappreciation of postprogression therapies.
  • Alternative trial design strategies are needed for more reliable estimation of treatment effects.