National Clinical Trials Quality Assurance Porgramme

The Irish Research Radiation Oncology Group (IRROG) was established in 2022 to build and support a national network for radiotherapy clinical trials. As part of The Health Research Board (HRB) grant objectives a national Quality Assurance (QA) programme for clinical trials has now been established.

This programme ensures the highest standards of accuracy, consistency and safety are applied in radiotherapy clinical trials. It represents an important step forward for cancer research in Ireland, enabling radiotherapy centres to collaborate on high-quality clinical studies both nationally and interantionally.

This programme was made possible through a generous charitable donation, which funded an additional staff physicist within the St Luke’s Radiation Oncology Network. This temporary post provided the resources required to design and deliver the project over a six-month period.

 

Achievements

  1. Building a Centralised Database

A centralised database has been developed to collect key information from each radiotherapy centre participating in clinical trials through IRROG. This includes details about each centre’s equipment, software, clinical staff, and current trials.

Having this information in one place makes it easier to coordinate national trials, maintain consistent quality standards, and avoid duplication of effort when new studies are launched.

 

  1. Developing QA Processes for Investigator-Initiated Trials (IITs)

A key goal of the project was to ensure that hospitals across Ireland follow best practice in radiotherapy clinical trial Quality Assurance.

The new national standards define:

  • How radiotherapy plans are prepared and reviewed.
  • How patient cases are checked before treatment.
  • How radiation dose measurements are verified and audited.
  • How feedback and communication are managed between centres.

This shared framework ensures that every patient in a trial receives the same high-quality treatment, no matter where they are treated.

These standards have already been applied to several IRROG-managed IITs, including SOURCE Lung, OPTIMISE Lung SABR, DP-IMRT Pancreas, and Spine SABR.

 

 

 

 

  1. Creating National Guidance for Future Trials

A concise national guidance document has been produced to support centres in developing and launching new IITs. It outlines how to include QA in every stage of trial design and delivery, supporting both clinicians and physicists involved in new research.

 

  1. Strengthening Collaboration and Communication

The QA programme has already encouraged stronger collaboration among radiotherapy centres across Ireland. Examples include the planning group for the Fast Forward Boost trial and the planning study group for the INSPIRE Prostate SABR IIT.

IRROG QA physicists also participate in the activities of the Global Harmonisation Group to strengthen ties with the various international QA groups such as IROC, RTTQA and EORTC, ensuring Ireland remains aligned with global best practice in radiotherapy quality assurance.

 

  1. Advancing Data Analysis

The introduction of the ProKnow software package provides a modern and efficient system for analysing radiotherapy data from clinical trials, facilitating more rapid and impactful research outputs. Funding for this package was generously provided by the Friends of St Luke’s.

 

Conclusion

The IRROG Quality Assurance programme establishes, for the first time, a coordinated national approach to radiotherapy QA in clinical trials. It ensures that every participating centre across Ireland meets the same high standards, enabling the country to run high-quality Investigator-Initiated Trials and to contribute to international studies.

The IRROG QA service now provides a strong foundation for future growth, supporting the ongoing development of trials such as INSPIRE Prostate SABR, and strengthening Ireland’s contribution to global advances in radiotherapy research.