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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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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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.
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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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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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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...
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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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...
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Corrigendum to "Ultra-high dose rate dosimetry for pre-clinical experiments with mm-small proton fields" [Phys. Med. 104 (2022) 101-111].

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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Defining robustness protocols: a method to include and evaluate robustness in clinical plans.

S E McGowan1, F Albertini, S J Thomas

  • 1Department of Oncology, University of Cambridge, Cambridge, UK.

Physics in Medicine and Biology
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We developed site-specific protocols to assess proton therapy plan robustness against errors. Range errors affected dose less than setup errors, guiding individualized treatment planning for better patient outcomes.

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Area of Science:

  • Medical Physics
  • Radiation Oncology
  • Proton Therapy

Background:

  • Clinical plan evaluation requires robust proton therapy protocols.
  • Skull base Intensity Modulated Proton Therapy (IMPT) plans need assessment for systematic range and random set-up errors.

Purpose of the Study:

  • To define site-specific robustness protocols for clinical IMPT plan evaluation.
  • To analyze plan robustness to range and set-up errors and explore strategies for improvement.

Main Methods:

  • Retrospective analysis of 16 skull base IMPT plans.
  • Calculation of error-bar dose distribution (ebDD) and definition of robustness metrics.
  • Creation of a database to aid in assessing plan robustness and identifying suboptimal plans.

Main Results:

  • Range errors had a smaller impact on dose distribution than set-up errors.
  • Organs at risk were more robust to range errors, while targets were more robust to set-up errors.
  • A new beam arrangement improved plan robustness and conformality for a specific case.

Conclusions:

  • Site-specific robustness protocols enhance clinical evaluation of IMPT plans.
  • Error-bar dose distribution (ebDD) and error-bar volume histogram are effective tools for robustness analysis.
  • Individualized treatment planning using robustness constraints and optimized beam arrangements can improve patient outcomes.