Ireland Standardizes Clinical Trial Agreements to Boost Trial Performance
Key Insights
Ireland is introducing a standardized four-way model template for clinical trial agreements (CTAs) to enhance its clinical trial performance.
The new template involves commercial sponsors, contract research organizations (CROs), academic partners, and hospitals, aiming to reduce costs and delays.
Standardized CTAs are expected to streamline the setup of new trials, addressing Ireland's underperformance compared to other European countries.
Ireland is taking steps to improve its clinical trial performance by standardizing clinical trial agreements (CTAs). The Health Service Executive (HSE) is developing a new four-way model template for CTAs to include commercial sponsors, contract research organizations (CROs), academic partners, and hospitals. This initiative aims to reduce costs and delays in trial initiation, addressing Ireland's underperformance in attracting clinical trials (search) compared to similar European countries.
Standardizing CTAs for Efficiency
The new CTA template builds upon existing bipartite and tripartite models. The tripartite model, effective since May 20, 2024, is mandatory for trials involving a commercial sponsor, a CRO, and one or more hospitals, provided contract negotiations began after this date. The bipartite CTA, involving a commercial sponsor and a hospital, took effect on August 23, 2024. According to the IPHA, the existence of multiple CTA versions has led to increased costs and delays.
Addressing Ireland's Clinical Trial Performance
According to a report published by IPHA in May, Ireland has been attracting fewer clinical trials (search) than comparable European countries like Finland and Denmark. The report indicated that, of 2,411 interventional clinical trials conducted between 2014 and 2023, only 19% (460) were in Ireland, compared to 27% in Finland (661) and 54% in Denmark (1,290).
Industry Collaboration
IPHA collaborates with the HSE in creating model CTAs to ensure they are fit for purpose. Rebecca Cramp, Director of Code & Regulatory Affairs at IPHA, emphasized that standardized templates save legal costs and time, preventing administrative delays that could hinder patient access to potentially life-saving clinical trials (search).
Broader Efforts to Expedite Trials
Similar efforts to expedite trial initiation are underway in the UK, where the Health Research Authority has consulted on a draft contract template to facilitate investigator-initiated CTAs between commercial and non-commercial organizations.