Irish patients excluded from drug trials for life-saving treatments due to barriers

Irish patients are being deprived of the chance of trialling potentially life-saving new drugs because of organisational and resource barriers in hospitals, new research suggests.

Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to analysis by the Irish Pharmaceutical Healthcare Association (IPHA).

Some 422 industry-sponsored clinical trials were carried out in Ireland between 2013 and 2021, with IPHA member companies involved in 294 of them.

Three out of every four trials were in phase three, the stage at which the medication can be tested on thousands of people against the performance of the best currently-available alternative. Cancer treatments accounted for just over half of all IPHA member-sponsored trials.

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According to the analysis, Ireland attracted fewer industry-sponsored interventional clinical trials in 2013-2021 than Finland and Denmark, whose populations and economic wealth are similar to the State's. Of 2,290 clinical trials carried out in the three countries, 18 per cent were conducted in Ireland compared to 29 per cent in Finland and 53 per cent in Denmark.

In all three countries, fewer clinical trials were conducted in 2019 and 2020 due to Covid-19.

"Ireland should aim to be a leader in clinical trials in Europe. This survey shows we are some distance off realising that goal," said Rebecca Cramp, director of code and regulatory affairs at the IPHA.

A standardised approach to conducting clinical research is being developed though a uniform agreement for clinical trials. “Standardisation means speed; the number of rounds of discussion and review for contracts should be reduced. That, in turn, should reduce the administrative and financial burden for hospitals and companies,” Dr Cramp said.

The IPHA has also called for standardised clinical trial start-up requirements and timelines for hospitals, designated signatories in each hospital with a standard sign-off process, and the appointment of one permanent clinical research nurse post for each teaching hospital. It also wants ring-fenced funding for clinical trials and dedicated working time for researchers.

According to a separate survey by Clinical Trials Ireland, three in five people would be willing to participate in a clinical trial, up from 48 per cent in 2020, and rising to four in five people if the person was very ill themselves.

Nine in 10 people think clinical trials are a good idea and three-quarters believe they have many safeguards, including ethical and regulatory review.