A new piece of the puzzle strengthens Sweden’s position in clinical trials.
An updated knowledge base on decentralised processes in clinical trials (DCT) has now been presented, further strengthening the view of Sweden as an attractive environment for the clinical trials of the future. The knowledge base has been developed by a working group with representatives from academia, healthcare and the pharmaceutical industry, with support from Swetrial.
At the core of this development is not the technology itself, but the opportunity to make clinical trials more accessible. Traditionally, participation has often required repeated visits to specialist clinics. With decentralised components – such as video visits, digital consent, home visits and remote follow-up – more patients can participate, regardless of where in the country they live. When parts of a trial can be conducted closer to the patient, barriers to participation are reduced and more people have the opportunity to contribute to and benefit from research.
– Decentralised approaches make it easier for patients to participate while also strengthening the conditions for conducting clinical trials in Sweden. This is crucial if we are to attract more trials and ensure that research and investment remain here, says Frida Lundmark, Director of Research Policy at Lif.
Trials closer to the patient
Decentralised elements in a clinical trial are not a separate model, but a natural further development of how clinical trials are already conducted today. However, not all clinical trials are suitable to be conducted fully decentralised. In many cases, a hybrid model, where some activities take place at a clinic and others remotely, is the most appropriate solution. Decentralised components should be used where they add value – for the patient, the conduct of the study and data quality.
– Decentralised clinical trials are crucial for creating the healthcare of the future. With more people in need of care, it is becoming increasingly important to care for the patients we can in their homes. This makes everyday life easier for patients and requires fewer resources from hospitals, but to get there, new research is needed, says Elham Hedayati, Director of Research, Education, Development and Innovation at Södersjukhuset in Region Stockholm, who was involved in developing the knowledge base.
Collaboration as an enabler
A key success factor for decentralised elements in a trial is collaboration. Experience shows that patients, healthcare providers and trial sites need to be involved early and in a structured way for decentralised elements to work in practice. This is a clear strength for Sweden. The established collaboration between industry, healthcare, academia, authorities and patient organisations creates strong conditions for developing and implementing new ways of working.
This means that decentralised trials can not only be designed, but also conducted in a safe and efficient way.
– This project is an excellent example of how Sweden can strengthen its position as a clinical trial country, and that strengthened collaboration in partnership is a recipe for success, says Helena Lüning, Head of Unit at Swetrial.
Sharing Sweden’s strong conditions
The working group consists of representatives from Uppsala Clinical Research Center, Region Stockholm and Lif, the trade association for the research-based pharmaceutical industry.
An English translation of the knowledge base will be available shortly. This material can be used to highlight to parent companies and colleagues around the world that Sweden has experience of, and is highly suitable for, DCT.
Would you like to know more about how UCR can support the development of clinical studies – for example through decentralised approaches, register-based randomised clinical trials (RRCT) or the use of quality registries? Please feel free to get in touch.