Advantages of digital clinical studies: evidence-based decision support

Digital clinical studies, also known as decentralised digital clinical trials (DDCTs), offer numerous advantages over traditional studies with on-site centres.

In an analysis of comparative clinical studies, we compared key performance indicators (KPIs) of clinical studies in hybrid and fully digital decentralised (possibly also "virtual") clinical studies.

Important key performance indicators for the quality of clinical studies are

(see here for details)

• Data quality and protocol compliance
• Recruitment (enrolment) and retention (keeping participants in the study) of study participants
• time management
• Cost control
• Regulatory compliance(adherence to legal requirements)
• Patient satisfaction
• Communication and collaboration
• Security and risk management

We used these key figures to compare hybrid with fully digital studies. Statistical corrections were made to ensure direct comparability and calculation.

Here are the figures:

• Accelerated recruitment:
• Digital studies enable 40 times as many inclusions per week with efficient international or cross-regional recruitment via digital media
• which significantly improves the ability to plan until the recruitment target is reached.

Increased efficiency in communication and recruitment

• Reduced communication effort: The internal and external communication effort per included patient is 8 times lower in digital studies.
• Centralised contact person: Only one contact person (MEDIACC) is required for ongoing recruitment and inclusion, which simplifies coordination.

Optimisation of the study implementation

• Shortened recruitment phase: The recruitment phase takes only a third of the time compared to studies with on-site centres.
• Reduced effort
  • :20% fewer queries10%
  • less monitoring effort80%
  • less communication on case clarifications
• Accelerated time to market: The time from initial contact to data evaluation (time to market) is reduced by 50%.

Improved patient eligibility and initiation

• Higher patient eligibility: Through pre-screening, we achieve 70% higher patient eligibility, which is roughly equivalent to the conversion rate.
• More efficient initiation: MEDIACC requires only half the time for initiation compared to on-site centres (four weeks versus eight weeks).

Challenges of traditional study models

• In hybrid studies, only 14% of the centres approached are initiated, despite the effort involved.
• Of the initiated centres, only half are actually actively involved in enrolling patients.

This data emphasises the significant benefits of digital clinical studies. MEDIACC utilises these insights to conduct more efficient, cost-effective and patient-friendly trials. By using digital technologies, we can not only optimise the conduct of studies, but also improve patient recruitment and retention, which ultimately leads to higher quality research results.

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