Ireland to streamline clinical trials to target faster patient access to treatments

By April Lara

May 22, 2024

Clinical trials

Ireland’s top pharmaceutical research firms have teamed up with the health service to launch a standardised site contract for tripartite clinical trials.

This comes hot on the heels of a report last week showing the country was falling behind similar sized EU countries in hosting clinical trials. That report said Denmark attracts almost three times as many industry clinical trials as Ireland.

The Health Service Executive (HSE) and Irish Pharmaceutical Healthcare Association (IPHA) have published the Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTA).

Ending the roadblock

Dr Rebecca Cramp, director of code and regulatory affairs at the IPHA, said: “We are pleased to announce the removal of a significant roadblock that negatively affected the conduct of clinical trials in Ireland.

“Today’s announcement represents the result of forward thinking by our government, close collaboration between the IPHA and HSE and dedication by all to a difficult-to-achieve outcome. Today’s roll out of the CRO-mCTA will reduce costs, decrease the administrative burden on hospitals and significantly increase the speed at which patients can get lifesaving interventions.”

Cutting through red tape

Clinical trials typically involve three key players:

• Sponsors who fund the trials, such as pharmaceutical firms
• Contract research organisations (CROs) that manage the trial logistics at the research site
• Research institutions such as hospitals, universities or other facilities where the trial occurs

Negotiating contracts between these parties can be time-consuming and complex. The CRO-mCTA provides a pre-defined agreement template for tripartite trials involving a CRO. This standardised format simplifies the contracting process by outlining clear terms and conditions for all parties involved.

The CRO-mCTA will be mandatory for any new mCTA negotiations with a CRO initiated after 20 May 2024. Negotiations started before then can continue under previously agreed terms.

By using the CRO-mCTA, hospitals, CROs, and sponsors can avoid lengthy negotiations and focus their efforts on setting up and conducting the clinical trial itself. This reduces delays and administrative burdens, which leads to faster access to potentially life-saving treatments for patients in Ireland.

More needs to be done

This focus on streamlining trials aligns with the IPHA's manifesto, which prioritises faster access to new medicines. In March this year ,the IPHA warned that lengthy approval delays, currently averaging more than two years for new drugs, can hinder patient care.

The IPHA says the CRO-mCTA is a step in the right direction but emphasises the need for a broader approach, including a more efficient European Medicines Agency and streamlined EU-wide clinical assessment processes.

Ireland's strong position in the pharmaceutical industry is no accident. The IPHA credits a consistent, long-term policy environment for attracting all the top 10 global pharmaceutical companies.

This, combined with Ireland's location within the EU and excellent global connectivity, positions the country as a prime location for clinical research. The CRO-mCTA is another building block in Ireland's ongoing commitment to innovation and improving patient outcomes.