Goal 2
Advance Ireland’s clinical trial ecosystem
Building an effective and competitive clinical trials ecosystem in Ireland that delivers for patients, the healthcare system and the economy
Ireland has a strong foundation in clinical research, with a distributed network of clinical research facilities, excellent academic investigators and globally competitive life sciences and medtech-industries. We will work with others to support both investigator-led and commercial clinical trials and RWE studies across all healthcare settings to maximise people’s access to trials in trusted, regulated and safe environments.
We will work with partners to create a competitive, agile and responsive clinical trials ecosystem that delivers for patients, the healthcare system and the economy by:
- Engaging with the Department of Health and other agencies under the auspices of the Clinical Trials Advisory Council (CTAC) to co-invest in a coordinated network of trials delivery units that will increase the number of both commercial and investigator-led clinical trials and the number of people who can access trials in Ireland
- Enhancing the capabilities and capacity of practitioners and researchers to design, conduct, oversee and report on the full spectrum of investigator-initiated trial types required to deliver safe, more effective and more equitable care across acute, primary, public health and community settings
- Investing in methodological research, training and advisory capacity so that innovative, robust and inclusive trial designs underpin the way trials are conducted, embracing innovations such as data-enabled trials and decentralised trials
- Working with the CTAC to support the establishment of a national portal for metrics and a dashboard reporting system for clinical trials, so that key performance indicators are consistent across the ecosystem and information on trials can be accessed by patients and the public.
We will increase the number and quality of clinical trials available to patients in Ireland by:
Increasing funding for high-quality investigator-initiated trials across a range of types and settings
Supporting the advancement of high-quality, multicentre trials through research networks in priority areas
Working with European and international partners to fund multinational investigator-initiated trials
Advancing clinical trial participation and standards through active involvement in the European Clinical Research Infrastructure Network (ECRIN)
Promoting policies and practices that reduce research waste, improve trial informativeness, enhance transparent and timely reporting, and enable PPI and diversity and inclusion in trials
Promoting a pre-submission consultation service to support the research community in navigating the submission requirements for national ethics opinions and consent declarations decisions that will drive quality and efficiency for research studies commencing in Ireland
Continuing our leadership and activities at European level by contributing to the Accelerating Clinical Trials in the EU (ACT EU) initiative and the EU4Health programme Joint Actions to support the implementation of the Clinical Trials Regulations and the Clinical Trials Information System (CTIS) for an effective clinical trials system nationally and across the EU.
We will advance a robust, transparent and dynamic national research ethics review system for regulated clinical research areas by:
Enabling the delivery of a single national ethics opinion for regulated clinical research through the work of the National Office and the NRECs it supports, and ensuring streamlined efficiencies with the consent declaration process of the HRCDC as required
Working with the Health Products Regulatory Authority (HPRA) to deliver trusted, coordinated national decisions for clinical research on medicines, medical devices and diagnostics within the prescribed EU-regulated timelines
Developing and implementing agile and efficient national research ethics assessment operations in response to new EU Regulations; the Biotech Act and Simplification Regulations for medical and in vitro diagnostic devices
Developing a framework to deliver a coordinated national assessment for multi-country studies that combine medicines, medical devices and diagnostics in collaboration with the HPRA and the NRECs.