Decentralised Clinical Trials: Benefits, Challenges, and Future Prospects

Decentralised clinical trials (DCTs) are becoming a common feature of the life sciences sector. Accelerated by the COVID-19 pandemic, the number of DCTs increased by 28% between 2021 and 2022. And that figure is expected to rise to 66% within the next five years. So, why is this happening? And what does it mean for the industry?

The Benefits, Challenges, and Future Prospects of Decentralised Clinical Trials

Benefits of decentralised clinical trials

The primary reason why DCTs have become an increasingly valuable asset to the life sciences sector is that they offer a range of considerable benefits. 

• Increased patient accessibility – The potential participant pool for clinical trials immediately broadens when the process is decentralised. Patients no longer have to be within an easy distance of the trial. Those with travel issues or mobility problems can now be considered. This means greater access to relevant participants while bringing diversity to the participant pool.
  
  

• Improved participant retention – The easier you make trial participation for patients, the more likely they are to engage with and continue with the process.
  
  

• Cost effectiveness – Centralised clinical trials can be expensive because there are so many additional overheads to cover. By moving to digital processes, DCTs minimise costs while maximising value.
  
  

• Real-time data – The new technology – wearable monitors, mobile apps, electronic data capture (EDC) systems – commonly deployed in DCTs provide real-time data and insights for greater precision and faster decision-making.

All of these things are working to further the appeal and uptake of DCTs. However, for all the benefits, the process is not without its challenges.

Challenges of decentralised clinical trials

Perhaps the greatest challenge faced in the implementation of DCTs comes from the reliance on technology. While digital tools have made DCTs possible, they can bring their own limitations. Whether it’s comprehension and functionality when deployed with the older demographic, or connectivity problems in more remote areas. The latter point can also lead to problems with regulatory compliance.

All data collected in a DCT must be secure, in accordance with regulatory standards, such as HIPAA and GDPR. If a participant does not have access to a secure internet connection, the DCT cannot guarantee that this will be the case. These issues can also be impacted by the countries in which the participants reside. With different regulatory frameworks to adhere to, this can be a difficult process.

Additionally, there are the issues of data integrity and quality control. When data is being collected remotely, it can be difficult to verify that it is relevant and accurate. To address this, robust authentication mechanisms often need to be put in place to mitigate risks.

Another challenge relates to medical oversight. When trial participants are spread across a variety of locations, the direct medical oversight demonstrated in traditional clinical trials must necessarily be absent. This can make the identification and treatment of adverse reactions extremely complicated, limiting the scope of DCT application.  However, this is something that could potentially be addressed through virtual consultations.

What lies ahead for decentralised clinical trials?

The future of DCTs is heavily bonded to the future of technology. Artificial intelligence (AI) and machine learning (ML) are opening up a range of new possibilities, including enhanced safety, predictive outcomes, decision-making, and predictive modelling. While advances in wearable technologies hold the potential to enhance the patient experience while increasing and improving the potential for monitoring.

Additionally, we’re likely to see a global standardisation of DCT regulations. This will not only facilitate cross-border clinical trials, but enhance safety throughout the industry.

DCTs are changing the ways in which clinical research is conducted. But while the process offers significant benefits, there are still plenty of challenges to overcome. It’s going to be fascinating to watch the space develop, and the opportunities it brings for those involved in the sector.

Are you looking for a new and exciting role within clinical life sciences? Find out how MRL can help.