Ireland Can Be A European Leader In Clinical Trials, IPHA Tells HRB-CRCI Conference

IPHA survey shows it takes about eight months to recruit the first patient into a clinical trial in Ireland

Ahead of International Clinical Trials Day, pharmaceutical innovators call for:

• The standardisation of site contracts (the Clinical Trial Agreement), in place in most other EU countries
• Protected research time for clinicians and hospital staff
• Realistic targets for clinical trials that are achievable and can be relied upon
• Partnership approach between clinicians, policymakers, patients and industry to eliminate delays recruiting patients

Ireland can have a lead role for clinical trials in Europe, the organisation representing pharmaceutical innovators, the Irish Pharmaceutical Healthcare Association (IPHA), told a conference today [Monday] ahead of International Clinical Trials Week.

Speaking at an event hosted by HRB-CRCI, in the Mansion House, Dublin, Dr Itziar Canamasas, Managing Director of the global life sciences company, Bayer, and representing IPHA urged clinicians, policymakers, patients and the innovator industry to continue to work together on steps that can improve Ireland’s performance on clinical trials.

Dr Canamasas said, “All of the key stakeholders including industry, must actively collaborative together to realise our shared ambition to make Ireland a leading location for clinical trials.”

The results of a recent IPHA survey presented today show that, on average, it takes about eight months to recruit the first patient into a clinical trial in Ireland. That figure is based on 90 trials set up between 2013 and 2018 across 11 therapy areas and all four phases of the clinical development process. The measure is the number of calendar days it takes to recruit a first patient into a trial from the date the company submits to a Recognised Ethics Committee – the international best practice structure for overseeing the conduct of ethical standards in healthcare research. In other countries, such as Denmark, the same process takes just  six months.

“Ireland can have a lead role for clinical trials in Europe,” said Dr Canamasas. “We can draw on our strong base of international pharmaceutical companies and highly regarded healthcare professionals who are experts in managing clinical trials together with a supportive public policy environment,” she added.

Patients have been shown to have significantly better outcomes by taking part in clinical trials.

“As well as the positive human health impact, clinical trials enhance the value proposition for innovation on which Ireland needs to keep working to secure future global investment in manufacturing and discovery activity against significant competition,” she said.

To help to continue taking steps to improve Ireland’s clinical trials performance, IPHA has called for:

• The standardisation of site contracts (the Clinical Trial Agreement) that is standard in a number of other EU countries. This will shorten delays and save on legal fees for both hospitals and companies;
• Protected research time for clinicians and hospital staff;
• Provide realistic targets for clinical trials that are achievable and can be relied upon.  This means meeting a lower target is better than partially meeting a higher target.

IPHA has welcomed the impending implementation of the Clinical Trial Regulation, and new ways of identifying and recruiting patients. It acknowledged investment in clinical research over the past decade. The HRB-CRCI feasibility service has processed 255 studies over the past four years. Most of these are pharmaceutical industry trials. Progress is being made in therapy areas including oncology, haematology, cardiology and respiratory and infectious diseases.

IPHA has also welcomed Ireland’s recent decision to join the European Clinical Research Infrastructure Network (ECRIN), with the potential to give us access to large populations of patients and collaborations across countries. The industry shares the Government’s hope that Ireland’s membership of ECRIN will help us to take on the country sponsor role for more pan-European clinical trials and ultimately benefit Irish patients.

Clinical trials are used to evaluate the safety and effectiveness of a medicine. Clinical trials can save lives and improve patient care. A strong clinical research infrastructure gives patients access to sometimes life-saving trials.