Decentralised digital clinical studies (DDCT)

Decentralised digital clinical trials (DDCTs) are clinical studies or investigations in which processes are digitalised and decentralised (outside a study centre). These studies are currently transforming clinical studies, as they offer enormous advantages over traditional clinical trials.

In DDCTs, digital technologies and methods are used to conduct parts or the entire study outside of traditional study centres.

Key aspects of a DDCT are:

• Use of technologies such as telemedicine, wearables, apps and electronic data capture
• Enabling study participation from home or in local health institutions
• Challenges: Data protection, quality assurance, regulatory requirements
• Agile processes and services.

DCTs can include various decentralised elements:

• Pre-checks for suitability
• Electronic consent (eConsent)
• Direct delivery of medication to participants
• Recording of endpoints via video consultations
• Telemedical visits
• Use of wearables for data collection
• Electronic patient questionnaires (ePRO)

Regulatory authorities such as the FDA and EMA have issued guidelines for DCTs.

The advantages of a decentralised digital clinical study

• They are more time and cost efficient.
• They are patient-centred, facilitate participation, are therefore more inclusive and increase participation.
• They lead to higher recruitment figures and, thanks to more diverse and representative samples, provide a better data basis for decisions in the healthcare system.
• They are less prone to errors, which saves time and, above all, frustrating work in monitoring and data management.
• They not only relieve the burden on us, but above all on the already overburdened medical study staff in the clinics.
• They save paper and many journeys and are therefore more environmentally friendly.

In December 2022, the ACT EU initiative published its first guideline on decentralised digital clinical studies, which provides initial guidance for all stakeholders. We have summarised the guideline for you. Read the most important points in brief.

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