Conducting clinical trials is essential to medicines development. However, it can be a complex, costly and time-consuming process. From patient recruitment and retention to trial design and data management, there are multiple hurdles on the road to medical innovation. 

The best way to overcome them is by working together. This means supporting intensive and ongoing collaboration across the clinical trials ecosystem. 

Europe has a strong track record in public-private partnerships in the life sciences. The Innovative Health Innovative (IHI), and its predecessor – the Innovative Medicines Initiative (IMI) – supports projects that drive systemic changes which can improve the clinical trials process from beginning to end.  

Making trials better for patients 

Take, for example, the challenges patients often face when taking part in clinical research. Traditional trials require them to travel to a specific location, often multiple times over several years. This can make it difficult to attract patients. It also reduces the pool of patients who can take part if participation is prohibitively difficult for those who live in rural areas or other locations far from research sites. 

For those who sign up, the burden can become too much to endure, prompting them to leave a trial before it has concluded. For researchers, high dropout rates mean higher costs and extended timelines. This can delay medicines development.  

One way to address these challenges is to decentralise clinical trials. This means that instead of conducting research at a central location – such as a university medical centre – some or all of the research activity can take place closer to the patient. Through remote monitoring, virtual consultations or visits to the patients home, access to trials can expand significantly.   

When it comes to unlocking the full potential of decentralised clinical trials, the challenge is to ensure that research conducted remotely or at multiple locations meets the highest standards. The Trials@Home project offers a robust assessment of decentralised clinical trial methodologies, their implementation, and their impact on moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. 

It is delivering actionable results and recommendations that can enhance the European clinical trial landscape, making it more patient-centric and paving the way for faster and more inclusive development of new medical treatments. 

Making research more inclusive 

Several IMI and IHI projects are working with patients and under-served communities to make research more inclusive. This brings benefits not only for populations that have been traditionally under-represented in clinical research, but also for researchers who can generate more representative data. 

• READI brings together a 73-member consortium to identify and overcome barriers to participation for underserved populations, such as ethnicities, LGBTQ+ individuals, older adults, and those from socioeconomically disadvantaged backgrounds, among others. Working across 18 countries, this new project will foster a more cohesive and integrated clinical studies ecosystem.  
• EU Pearl has developed master protocols and other templates and tools for use in platform trials – a kind of clinical study that tests several compounds at once (and may continue running, testing new treatments). 
• RealiseD will explore the potential of real-world evidence and digital health technologies to accelerate the development of treatments for people living with rare and ultra-rare diseases. 
• Connect4Children aims to address the challenges of conducting paediatric trials, ultimately contributing to better medicines for babies, children and young adults. 

Taken together, these initiatives will help to de-risk clinical trial design. They will clear bottlenecks in ways that help the entire research community and the millions of patients who rely on innovation for new therapies. 

Public-private partnership works. IHI projects are delivering concrete tools and infrastructure, and establishing robust networks of research-driven partners that fulfil the needs and requirements of public and private sectors. Through simplification and capacity building, these collaborations can help Europe to become a more attractive place to conduct clinical research. 

All this fully aligns with the ACT EU vision for accelerating clinical trials in the EU, and with the Competitiveness Compass which seeks to reignite Europe’s economy.  

As we mark Clinical Trials Day, we should celebrate the role of public-private partnerships in catalysing the changes we need. We can make European research more efficient, effective and competitive, by doing more together. 

- - - 

Discover more on the Innovative Health Initiative on efpia.eu