Advantages of digital clinical trials: evidence-based decision support

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

In an analysis of comparative clinical trials, we compared key performance indicators (KPIs) of clinical trials in hybrid and fully digital decentralised (possibly also “virtual”) clinical trials of medical devices.

Important key performance indicators for the quality of clinical trials are

• 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 trials. 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.
• This significantly improved 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 (in MEDIACC) was required for ongoing recruitment and inclusion, which simplified coordination.

Optimisation of the study implementation

• Shortened recruitment phase: The recruitment phase only takes a third of the time compared to studies with on-site centres.
• Reduced effort
  • 20% fewer queries
  • 10% less monitoring effort
  • 80% less communication on case clarifications
• Accelerated time to market: The time from initial contact to data evaluation (time to market) was 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 required 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 24% of the centres approached were initiated, despite all effort involved.
• Of the initiated centres, only half were actually actively involved in enrolling patients.

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

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