The European Medicines Agency (EMA) published a recommendation paper on Decentralised Clinical Trials (DCTs) with the aim of facilitating the conduct of DCTs while ensuring the protection of participants’ rights and well-being, as well as the reliability of the data collected.

According to the EMA, DCTs are clinical trials that “use remote or virtual methods to collect data from participants at sites other than the traditional clinical trial site”. The biggest potential benefit of this new approach is increased access and participation. By moving parts of clinical trials out of specialised hospitals and research centres into the community, it allows for a much broader and diverse pool of potential participants. This can help ensure trials represent the actual populations who will use the IPs, improving external validity. It also makes participation more convenient for those who cannot easily travel to research sites.

Another key advantage is cost reduction. Decentralised elements like remote monitoring, virtual visits, and digital data collection can lower the operational expenses of running trials. This may enable more trials to be conducted within constrained budgets. However, the upfront investment in digital infrastructure needs to be weighed against these potential savings.

While DCTs have many potential benefits, there are also some drawbacks that should be considered to ensure the validity and reliability of the study results.

Firstly, the paper emphasizes the limited regulatory oversight for DCTs as these types of studies may involve more sites and participants than traditional clinical trials, making it more challenging for sponsors and regulators to monitor and ensure compliance with the study protocol. This could lead to data quality issues and other problems that could affect the validity of the study results.

The second point is data security: DCTs rely heavily on technology and data transfer, which can increase the risk of data breaches and cyber-attacks. This is a significant concern for sponsors and regulators, as it could compromise the confidentiality and integrity of the study data.

Moreover, patient and healthcare personnel training is critical for the success of the experimental phase; on the one hand, participants should be taught how to use new technologies, such as wearable devices, mobile apps, or telemedicine platforms. On the other hand, study coordinators and site personnel may need instructions on remote monitoring tools, virtual visits, and data quality and integrity.

In summary, decentralised clinical trials present an opportunity to make medical research more inclusive, efficient, and representative. But a careful and validated implementation is required to maintain scientific rigour while harnessing the potential of new technologies. The EMA recommendations provide a framework for drug developers and regulators to evaluate how decentralised elements can be incorporated into future trials in ethical and effective ways.

At Evidilya, we have always been at the forefront of innovation, striving to engage patients and streamline the entire clinical trial process. Recognizing the potential of Decentralised Clinical Trials (DCTs) and the EMA’s recommendations, we are committed to integrating cutting-edge technologies and approaches to enhance patient access, reduce costs, and maintain the highest standards of data quality and security. Check out our website for more info!