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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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Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies

Proton Therapy Delivery and Its Clinical Application in Select Solid Tumor Malignancies

Published on: February 6, 2019

Minimum data elements for the Australian Particle Therapy Clinical Quality Registry.

Eunji Hwang^1,2, Peter Gorayski^3,4,5, David Thwaites²

¹Department of Radiation Oncology, Sydney West Radiation Oncology Network, Sydney, New South Wales, Australia.

Journal of Medical Imaging and Radiation Oncology

|July 7, 2023

Summary

A consensus identified 27 essential Minimum Data Elements (MDEs) for Australia's national particle therapy (PT) registry, ASPIRE. This registry is crucial for collecting data on PT patient and tumor outcomes.

Keywords:

Delphi method heavy ion therapy proton therapy registries routinely-collected data

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Area of Science:

Oncology
Medical Physics
Health Informatics

Background:

Australia is establishing its first particle therapy (PT) center.
A national registry, the Australian Particle Therapy Clinical Quality Registry (ASPIRE), is mandated for PT reimbursement.
This study aimed to define the core data for ASPIRE.

Purpose of the Study:

To establish a consensus set of Minimum Data Elements (MDEs) for the Australian national particle therapy registry (ASPIRE).
To ensure comprehensive data collection for quality assurance and clinical evidence development in particle therapy.

Main Methods:

A modified Delphi and expert consensus process was employed.
International PT registries were reviewed to identify common MDEs.
A three-round process involving surveys, polls, and expert discussions refined the MDEs.

Main Results:

123 unique MDEs were identified across four international registries.
A consensus process resulted in 27 essential MDEs for ASPIRE.
These include 14 patient factors, 4 tumor factors, and 9 treatment factors.

Conclusions:

The 27 MDEs form the mandatory core data for the ASPIRE registry.
Registry data is vital for building robust clinical evidence on PT outcomes.
This evidence will support the clinical benefit and cost-effectiveness of PT.