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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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Related Experiment Video

Updated: Jun 23, 2025

Irradiator Commissioning and Dosimetry for Assessment of LQ α and β Parameters, Radiation Dosing Schema, and in vivo Dose Deposition
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Quality Assurance in Radiotherapy (RT)-Specific Trials: Indian Scenario.

A Mahata1, S Chakraborty1, S Mandal1

  • 1Department of Radiation Oncology, Tata Medical Center, Kolkata, West Bengal, 700156, India.

Clinical Oncology (Royal College of Radiologists (Great Britain))
|June 19, 2024
PubMed
Summary
This summary is machine-generated.

Radiotherapy trial quality assurance (RTTQA) is inconsistently reported in Indian randomized controlled trials (RCTs). This study reviews RTTQA practices, highlighting diverse approaches and challenges in implementing effective quality assurance for improved patient outcomes.

Keywords:
Dosimetryradiotherapyradiotherapy trial quality assurancerandomised trials

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Area of Science:

  • Radiation Oncology
  • Clinical Trial Methodology
  • Quality Assurance in Healthcare

Background:

  • Proper radiotherapy trial quality assurance (RTTQA) is linked to better patient outcomes.
  • Current RTTQA practices in clinical trials are heterogeneous and vary significantly.
  • There is a need to understand the implementation and challenges of RTTQA in the Indian context.

Purpose of the Study:

  • To review radiotherapy trial quality assurance (RTTQA) reports for randomized controlled trials (RCTs) conducted in India.
  • To present the experience and findings of RTTQA implementation in various clinical trials.
  • To identify key achievements and challenges associated with RTTQA in Indian clinical trials.

Main Methods:

  • A literature search was conducted for RCTs published between 2019-2024, focusing on radiotherapy and Indian affiliations.
  • Reporting of RTTQA procedures and dosimetric goals from publications and protocols was documented.
  • RTTQA procedures and results from four representative clinical trials at Tata Medical Center were evaluated.

Main Results:

  • Only one out of 24 RCTs formally reported RTTQA.
  • Formal dosimetric goals were pre-specified in 9 of 13 trials using Intensity-Modulated Radiation Therapy (IMRT).
  • RTTQA was tailored for each trial, focusing on homogeneity, dose spillage avoidance, dose delivery constraints, and target volume segmentation.

Conclusions:

  • Demonstrates varied RTTQA procedures tailored for specific clinical trial needs.
  • Highlights significant challenges encountered during the implementation of RTTQA.
  • Emphasizes the importance of customized RTTQA for ensuring trial integrity and patient safety.