Decentralized clinical trials (Decentralized Clinical Trials, DCTs) are clinical trials in which study activities take place wholly or partly outside a traditional trial site—for example, in participants’ homes, via telemedicine, or through mobile nursing services.
In practice, the hybrid trial model is often implemented: On-site visits (e.g., for screening, biospecimen collection, safety assessments) are combined with decentralized elements (e.g., home nursing, eConsent, remote patient monitoring via wearables). Hybrid designs offer the benefits of decentralized trials (improved patient recruitment, reduced burden) while maintaining clinical standards.
From a regulatory perspective, GDPR requirements for data protection in decentralized data collection must be observed. The EMA has published a recommendation paper on DCTs (EMA/DC/2022), and the FDA has issued guidance on Decentralized Clinical Trials (2023). For CROs, this creates a growing business area in technology integration (ePRO, eConsent, BYOD solutions) and the coordination of mobile nursing services.