Each year on 20th May, the international healthcare community recognises the work that has been accomplished in the field of clinical research and acknowledges the breakthroughs that have only been possible through true collaboration. In truth, these achievements should be celebrated year-round as they will impact the lives of each and every one of us in one way or another.
If I asked someone to name a type of cancer, they probably wouldn’t say multiple myeloma. Yet it is the second most common type of blood cancer and every year in Ireland around 350 people are diagnosed with this incurable disease.
Multiple myeloma is a complex condition that presents in myriad and often non-specific ways, beginning insidiously in the bone marrow and characterised by an excessive proliferation of plasma cells.
Historically, treatment options were limited and crude, but recent medical advances have completely transformed how multiple myeloma is managed. In the past two decades, survival rates for multiple myeloma have soared, thanks to a combination of advances in technology, a wave of innovative research, and heightened public awareness. Irish data shows that the five-year net survival for someone diagnosed with multiple myeloma has increased by 37 per cent, from 27 per cent to 64 per cent in the period from 1994-2018.
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Janssen has been at the forefront of these advances in the management of multiple myeloma. Our portfolio in multiple myeloma includes compounds with different modes of action and multiple combination options to best address the unmet needs that we and the multiple myeloma community have identified together through research. As our current medicines portfolio continues to expand, we will have the ability to treat all patients across all stages of the disease.
A complex disease, it requires complex management - nowadays most patients will receive a number of different treatments. This means balancing the combination of treatments - as well as the timing - to maximise the benefit of the agents but minimise their side effects is challenging for the treating clinician.
International Clinical Trials Day
Yet, these advances are worthless if Irish patients cannot access them. Tomorrow is International Clinical Trials Day, and while Ireland’s ability to attract and participate in major clinical trials has brought ground-breaking medicines to thousands of cancer patients, many thousands more are missing out due to delays in opening trials here and the lack of the necessary infrastructure.
Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to the latest IPHA Clinical Trials Performance Survey, capturing data from 2013 to 2021. The survey found that Ireland attracted fewer industry-sponsored interventional clinical trials than Finland and Denmark whose populations and economic wealth are similar to ours. Of the 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.
This poorer performance is all the more disappointing given that Ireland is a leading destination for the biopharmaceutical industry in terms of its manufacturing and development investment, yet it is failing to attract the proportion of clinical trials that could be expected to accompany this footprint. As an example, at our biopharmaceutical facility in Cork, we produce and supply medicines for clinical trials that other countries have successfully attracted.
Access to breakthrough medicines
A range of reforms are needed to allow greater access to beneficial breakthrough medicines for patients including appointing one permanent clinical research nurse post per teaching hospital and ring-fencing clinical trial funding and working time for multidisciplinary research. Some reforms are in progress, and in November 2022 IPHA collaborated with the State Claims Agency and the HSE in the creation of a standard Clinical Trial Indemnity Form and Clinical Trial Agreement which have already substantially improved the start-up efficiency of clinical trials.
This is not just an Irish problem – Europe is also falling behind international counterparts in prioritising pharmaceutical research and development (R&D) and the gap is growing ever wider. Pharmaceutical R&D expenditure in the US in 2020 exceeded that in Europe by over €20 billion. This gap is widening: 20 years ago, in 2002, the difference was only €2 billion. In 2020, Europe accounted for just 19.3 per cent of global clinical trials, compared with an average of 25.6 per cent over the last 10 years.
The new EU Pharmaceutical Strategy is a once-in-a-generation opportunity for Europe to reverse this trend and re-establish its global leadership in biomedical innovation, R&D and clinical trials. Ireland should take a stance with other Member States that will incentivise more R&D, clinical trials and new treatments for patients in Europe.
Advancing scientific knowledge
In recent years, Janssen Sciences Ireland has supported numerous Investigator Initiated Studies (IIS), including preclinical and clinical research and trials, led by Irish physicians, with the purpose of advancing scientific knowledge and investigating novel treatment options for multiple myeloma. For instance, the lead investigator for a recent international multiple myeloma trial, MAIA, was based in Galway. In January this year, the first ever clinical study in Ireland of CAR-T cell therapy for treating multiple myeloma opened at St James’s Hospital Dublin and brings the newest, most transformational approach to the way we tackle this complex disease.
We are eager to continue to collaborate with healthcare partners aligned with our vision in multiple myeloma, who can help us anticipate and address the unmet needs for healthcare providers and patients as we urgently work together to find curative regimens. Solving the clinical trials conundrum cannot be done in isolation and will require true partnership between industry leaders, policymakers, healthcare professionals and patients.
Curing multiple myeloma is our mission. We will never settle until we can get in front of cancer, deliver cures, and eliminate multiple myeloma.
I would like to thank the people who make clinical trials and the advancement of new medicines possible for Irish patients and their families. Together we aspire to make disease a thing of the past.
References available upon request.