Cancer Trials Ireland is leading a new national initiative focused on reducing the time it takes to open regulated cancer clinical trials at sites in Ireland.
The Site Start-up Timelines Working Group brings together Cancer Trials Ireland’s operational and clinical expertise with investigators and research professionals from sites across the country. Its focus is on identifying and testing practical changes that could make the trial start-up process faster and more efficient.
The need for improvement is clear. For clinical trials commenced in Ireland between 2023 and 2025, the average time from EU approval to the first site being ready was 213 days.
The National Clinical Trials Oversight Group has recommended a target of 70 days from approval to first patient recruited, including 42 days from approval to contract sign-off.
A number of processes must be completed before a clinical trial can open at a site. At present, many of these take place sequentially after regulatory approval. The Working Group will examine where activities could instead be progressed in parallel, including before anticipated approval, with the aim of reducing unnecessary delays.
Rather than revisiting barriers that have already been well documented, the initiative is designed around implementation and testing.
The group will map the current activation pathway across a representative sample of cancer trials and Irish sites, establish baseline performance, identify common and trial-specific bottlenecks, and design an accelerated parallel workflow. This revised approach will then be piloted on one or two trials progressing through the approval process, with its impact assessed against the baseline.
The programme will run through the second half of 2026, with a pilot of the accelerated workflow planned for October. Early findings will be reviewed in November, followed by a final report and recommendations in December.
Success measures will include a reduction in approval-to-activation timelines, moving more activities from sequential to parallel processing, greater streamlining of site “green light” processes, and adoption of agreed workflow recommendations.
As Ireland’s national cancer trials network, Cancer Trials Ireland has a central role in bringing together expertise from across the system and helping translate national recommendations into practical improvements.
The Working Group is chaired by Jacinta Marron, Head of Operations, Cancer Trials Ireland.
Its members are:
- Prof Seamus O’Reilly, Clinical Lead, Cancer Trials Ireland
- Olivia McLoughlin, Head of Start-up, Cancer Trials Ireland
- Emer Mulvaney, Contracts Manager, Cancer Trials Ireland
- Dr Anne Fortune, Consultant Haematologist, Mater Misericordiae University Hospital
- Dr Lynda Corrigan, Consultant Medical Oncologist, Tallaght University Hospital
- Keith Egan, Programme Manager, Cancer Clinical Trials & Research Unit, Beaumont Hospital
- Claire Brady, Research Manager, Cork University Hospital
- Caroline Kelly, Senior Manager, Clinical Research & Development Office, HSE West and North-West Health Region, University Hospital Galway
Rinu Mary Thomas, Study Start Up Specialist, University Hospital Galway
Olivia McLoughlin also serves as Secretariat and Coordinator for the group.
The Working Group will report through Cancer Trials Ireland’s Clinical Executive Committee, with its final report and recommendations submitted to the Cancer Trials Ireland Board at the conclusion of the programme.