Purpose of the FTLI pathway
Cancer Trials Ireland’s Fast-Track Low-Interventional (FTLI) pathway provides a proportionate approach to sponsoring suitable low-risk, unregulated investigator-initiated studies. Selected collaborative studies may also be considered.
The pathway is intended for studies that do not require the full Cancer Trials Ireland study-management model, where investigators and study teams can undertake much of the study development, set-up and delivery work, with clearly defined support and oversight from Cancer Trials Ireland.
Which studies may be suitable?
FTLI may be appropriate for studies that have:
A well-developed concept or draft protocol
A low-risk study design with proportionate Sponsor requirements
An investigator and study team with the resources to lead set-up and delivery
A limited requirement for central Cancer Trials Ireland support
Studies should be able to use Cancer Trials Ireland templates and standard processes wherever possible.
How to submit an enquiry
Investigators who have a potential FTLI study should contact fasttrack@cancertrials.ie with a short description of the proposed study and any available protocol or supporting documentation.
Cancer Trials Ireland will assess the potential suitability of the study and discuss the proposal with the relevant Chief Investigator and Cancer Trials Ireland Clinical Lead or Vice Clinical Lead.
What Cancer Trials Ireland can provide
Depending on the study’s requirements and available resources, Cancer Trials Ireland may provide:
Sponsorship, insurance and proportionate Sponsor oversight and governance
Support with ethics, contracts, data protection and site activation
Biometrics support, including database development, data management and statistics, where appropriate
The investigator and study team retain responsibility for scientific leadership and much of the work involved in developing and delivering the study.
How are studies assessed?
Cancer Trials Ireland considers a range of factors when assessing suitability for the FTLI pathway, including study design and risk, Sponsor responsibilities, investigator and site-team resources, funding, data requirements and operational capacity.
FTLI is supported by a limited pool of shared Cancer Trials Ireland resources rather than dedicated resources for individual studies. Suitable studies may therefore need to be prioritised or progressed in sequence, depending on available capacity.
FTLI is a proportionate operational pathway and does not replace the usual DSSG scientific review and prioritisation processes. Normal DSSG approval continues to apply, and studies are noted at SMG.
Further information
For further information about the FTLI pathway, or to discuss whether a proposed study may be suitable, please contact fasttrack@cancertrials.ie.
