A Decentralized Clinical Trial (DCT) is a model where some or all of the clinical trial activities take place remotely, outside of a traditional clinical trial site. This is achieved through the use of technology, such as telemedicine, mobile healthcare providers, and digital health tools (e.g., wearable sensors, apps, and electronic consent or e-Consent).
The primary goal of a DCT is to bring the study to the patient, rather than requiring the patient to travel repeatedly to a central research facility. This approach significantly improves patient recruitment and retention by reducing the burden of participation, thereby increasing the diversity and representativeness of the study population. For the pharmaceutical industry, DCTs can accelerate timelines and reduce logistical costs. However, they require careful implementation to ensure Data Integrity and strict adherence to regulatory standards like Good Clinical Practice (GCP), which must be adapted for remote data collection and monitoring. DCTs represent a future-focused strategy for making clinical research more agile and patient-centric.
