Ireland steps up efforts to improve clinical trial performance by standardising CTAs :: Pink Sheet

According to the Irish Department of Health, a new four-way template for Clinical Trial Agreements (CTAs) is currently being developed to improve the country's clinical trial performance.

“Work has begun on producing a template CTA for four-party engagements involving a commercial sponsor, a contract research organisation (CRO), an academic partner and one or more hospitals and we hope to publish this template soon,” the HSE said.

The new template, which is being developed in collaboration with the pharmaceutical industry association, the Irish Pharmaceutical Healthcare Association (IPHA), will complement the existing two- and three-tier templates.

The tripartite CTA model came into effect on 20 May this year and is mandatory for trials involving a commercial sponsor, a CRO and one or more hospitals if contract negotiations begin after that date. However, if negotiations began before 20 May, “the CTA that is already the subject of negotiations may still be used for that specific clinical trial,” the HSE noted.

The bilateral CTA involving the commercial sponsor and a hospital entered into force on August 23 (with the same reservation regarding ongoing negotiations).

According to a report published by IPHA in May, fewer clinical trials are conducted in Ireland than in some European countries with similar populations and economies, including Finland and Denmark.

Of the 2,411 interventional clinical trials conducted in the three countries in the ten years between 2014 and 2023, “19 percent were conducted in Ireland (460), compared with 27 percent in Finland (661) and 54 percent in Denmark (1,290),” the report said.

IPHA sees one way to improve the situation in standardised CTAs for studies with CROs – an approach that is already common practice in many other EU countries.

“Until now, there have been several slightly different versions of these CRO CTAs, each of which has been subject to review, costing hospitals money and delaying the start of clinical trials,” the association said when the tripartite CTA came into effect.

IPHA is working with the HSE to produce the model CTAs, “with both organisations ensuring the templates are fit for purpose,” Rebecca Cramp, IPHA’s Director of Code & Regulatory Affairs, told the Pink leaf“A standardized template saves legal costs, saves time and ensures that our patients are not prevented by administrative delays from participating in sometimes life-saving clinical trials.”

In the UK, measures are currently being taken to speed up the start of certain trials. Over the summer, the Health Research Authority put out for consultation a model contract designed to help commercial and non-commercial organisations set up investigator-initiated CTAs more easily. (See also “Model contract to speed up UK clinical trial negotiations between non-commercial sponsors and companies” – Pink Sheet, 8 April 2024.)