hybrid trial designs – Clinical Research Made Simple

Decentralized Clinical Trials: Lessons from Recent Implementations

August 17, 2025

Decentralized Clinical Trials: Lessons from Recent Implementations Decentralized Clinical Trials: Implementation Lessons and Regulatory Oversight Introduction: The Rise of Decentralized Clinical Trials Decentralized Clinical Trials (DCTs) leverage digital technologies, telemedicine, and direct-to-patient logistics to reduce reliance on traditional site-based models. For US sponsors, the FDA encourages decentralized elements where appropriate, particularly under the 2020 FDA…

Clinical Trial Operations & Compliance, Clinical Trial Phases & Design

Decentralized Strategies for Reaching Rare Populations

August 2, 2025

digi

Decentralized Strategies for Reaching Rare Populations Reaching Rare Disease Patients Through Decentralized Trial Strategies Why Decentralization Matters in Rare Disease Clinical Trials Rare disease clinical trials often face the dual challenge of low patient numbers and wide geographic dispersion. Traditional site-based models are typically unviable due to the logistical burden placed on patients and families,…

Patient Recruitment Challenges, Rare and Orphan Disease Trials