Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)

Decentralized Clinical Trials (DCTs) are fundamentally transforming clinical data collection, introducing both significant opportunities and complex challenges regarding data quality, management, and integration5.

The DCT model leverages technologies such as telemedicine, remote monitoring, wearable devices, and AI-powered analytics to enhance patient accessibility, engagement, and real-time data capture25.

DCT adoption accelerated following the COVID-19 pandemic, with the market projected to grow at over a 14% CAGR, surpassing $21 billion globally by 20305.

Recent studies show that key data quality metrics and patient safety are not adversely affected by DCT elements; protocol deviations and dropouts even decreased during the initial pandemic implementation phase3.

Adoption of DCTs has improved participant diversity, especially by reducing geographic and logistical barriers for patients in rural areas or those with limited site access13.

Despite their benefits, most DCTs remain single-country (over 80%), with limited multiregional trials due to regulatory, technical, and operational challenges5.

Data from the Tufts CSDD and the PACT consortium suggests that DCT-supported trials often achieve improved timelines for patient enrollment and more diverse participant demographics compared to traditional models1.

Regulatory agencies are now emphasizing risk-based oversight, robust data traceability, and greater flexibility to accommodate the complexity of decentralized models52.

Sponsors must rethink trial data architectures, integrating disparate data streams from digital solutions while maintaining compliance and ensuring reliability, accuracy, and patient privacy5.

Sources:

1. https://curavit.io/press/decentralized-clinical-trials-bust-or-breakthrough/

2. https://www.healthcareittoday.com/2025/05/07/ai-and-decentralized-trials-a-new-era-in-drug-development/

3. https://www.asco.org/news-initiatives/policy-news-analysis/decentralized-cancer-trials-safe-adopt-without-hurting-data-increasing-risk

5. https://www.fiercebiotech.com/sponsored/rethinking-clinical-trial-data-era-decentralization