IPHA urges major reforms in clinical research to help accelerate new medicines development

New survey shows Denmark is attracting three times as many clinical trials as Ireland as barriers here slow patient recruitment speeds

Major process reforms are needed in the clinical trials process to help accelerate new medicines development, according to the Irish Pharmaceutical Healthcare Association (IPHA) which represents the international originator biopharmaceutical industry.

The call, during Science Week, emerges as the IPHA Clinical Research Survey 2020 shows Denmark is attracting three times as many clinical trials as Ireland. Between 2013 and 2019, Ireland conducted 338 clinical trials across four phases, according to data from clinicaltrials.gov. In Denmark, the number was 918. Finland recorded 509 clinical trials.

IPHA gathered data from 181 industry-sponsored clinical trials, with most of the findings, or 72%,  emerging from Phase III. Cancer was the disease area that accounted for 61% of the clinical trials. That was followed by cardiovascular disease at 7% and then a range of therapy areas, including respiratory, neurology, immunology and diabetes.

The research shows a strong correlation in Denmark and Finland between the number of patients enrolled and the number of clinical trials undertaken.

It takes at least two months longer to recruit a patient on a clinical trial in Ireland compared with Denmark and Finland, according to the survey. The wait time in Ireland is, on average, 246 days. 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.

IPHA said that with the right process reforms Ireland can be a leader in Europe in clinical research.

“Ireland can have a lead role for clinical trials in Europe,” said Dr Rebecca Cramp, Scientific and Regulatory Affairs Manager at IPHA. “We have a strong base of international biopharmaceutical companies, alongside global clinical leaders, and a willing and adaptive policymaker community. Reforms are needed in the clinical trials process – and, if we get them right, more patients will benefit from breakthrough medicines innovation.”

IPHA outlined the process reforms it believes are needed. They include:

  • Introduce an Ireland-wide standard site contract (the Clinical Trial Agreement) so that trial start-up delays in hospitals are reduced;
  • Implement protected research time for clinicians and hospital staff;
  • Improve Recognised Ethics Committee (REC) review and approval timelines;
  • Standardise processes for all RECs, with no specific requirements at individual RECs;
  • Require that hospital sites adhere to patient recruitment commitments;
  • Demand consistency in the approach to clinical research across all institutions;
  • Establish the National Research Ethics Committee to drive performance and ensure accountability for all clinical trials;
  • Implement electronic patient records across all hospitals; and,
  • Facilitate sharing best practice across hospital sites.

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 and help us to attract global investments,” said Dr Cramp.

Professor Joe Eustace, Director of the HRB Clinical Research Facility at University College Cork and Chair of the Senior Management Team of HRB-CRCI, said: “Clinical trials are the critical process by which we determine whether potential medical interventions are safe and effective. The COVID-19 pandemic has given us an increased appreciation of their critical importance and of the need to continue to develop the Irish national clinical research infrastructure to facilitate the conduct of such trials.”

IPHA acknowledged public investment in clinical research over the past decade. The HRB-CRCI feasibility service has, in recent years, helped to process hundreds of clinical trials, with most of them sponsored by biopharmaceutical companies. Progress is being made in therapy areas including oncology, haematology, cardiology and respiratory, and infectious diseases. Ireland’s membership of the European Clinical Research Infrastructure Network should enable us to participate in more EU-wide research projects with increased collaborations across countries.

ENDS

About The Survey

Fifteen originator biopharmaceutical companies responded to the IPHA survey. All of them

conducted clinical trials between 2013 and 2019. The number of clinical trials the companies conducted overall was 181. The comparator countries of Demark and Finland were chosen on the basis of population and economic wealth.

About Clinical Trials

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

About IPHA

IPHA represents the international research-based pharmaceutical industry. Our members discover and develop innovative medicines for treating or curing medical conditions and diseases. We aim to improve people’s health through innovative medicines and technologies. Our public policy advocacy and reputation agenda is supported by the consumer healthcare division for over-the-counter medicines and by medicines.ie which provides accurate, regulator-approved medicines information.

ENDS