Presentation (CTI)

OBJECTIVES: In Ireland, a Rapid Review (RR) is an accelerated mechanism to assess clinical effectiveness of an intervention against a comparator. Due to the rapid nature, it is often impossible to fully assess networks of data and is therefore often based on direct head-to-head trials. Without a robust assessment of comparative effectiveness, there remains uncertainty on how effective new treatments are relative to existing ones. Joint Clinical Assessments (JCA) include ITC in their scope and provide independent assessment of relative effectiveness. This research aimed to assess how JCAs may inform the RR process by identifying the proportions of JCAs initiated under the EU HTAR that include pivotal trials with direct comparisons against treatments representing the SoC in Ireland, and those that require an ITC.
METHODS: Ongoing JCAs were identified from the publicly available list dated June 9th, 2026. Pivotal trials were sourced from the International Horizon Scanning Initiative (IHSI) database and/or clinicaltrials.gov. Relevant comparators were extracted from the national response to the corresponding PICO surveys.
RESULTS: Among the initiated JCAs (n=16), pivotal trials in 12.5% (n=2) included direct comparisons against all relevant comparators in the Irish national PICO, and 18.75% (n=3) included direct comparison against some of the comparators. In pivotal trials for 11 JCAs there was no direct evidence to address any of the PICOs of relevance for Ireland.
CONCLUSIONS: The results show that most pivotal trials supporting products undergoing JCA do not include direct comparisons against the Irish SoC, hence most JCA reports will provide relative effectiveness evidence based on ITC. These outputs will become available inputs to national procedures providing a broader evidence base for RRs and earlier information on comparative effectiveness for decision-making. Additionally, this will benefit full health technology assessments (HTA) since clinical evidence would have been completed at the EU level prior to assessment at the national level.