Decentralized and Hybrid Clinical Trials: The Future of Clinical Research
Clinical trials are an essential component of the drug development process, but they can be time-consuming, expensive, and logistically challenging. Decentralized and hybrid clinical trials are emerging as a solution to these challenges. In this blog, we will explore what decentralized and hybrid clinical trials are, their differences, who they are for, and why a clinical platform is required.
What are Decentralized and Hybrid Clinical Trials?
Decentralized clinical trials (DCTs) are trials in which some or all trial activities are conducted at a site other than the investigator’s site, such as a patient’s home. DCTs leverage technology to enable remote communication and data collection. Hybrid clinical trials (HCTs) are a blend of traditional and decentralized trials, where some activities are conducted on-site, and others are conducted remotely.
Differences between Decentralized and Hybrid Clinical Trials
The main difference between DCTs and HCTs is the degree of decentralization. In DCTs, most, if not all, trial activities are conducted remotely, while in HCTs, some activities are conducted on-site. HCTs may be more suitable for studies that require a physical exam or monitoring, while DCTs may be better for studies that involve self-administration of drugs or patient-reported outcomes.
For Whom are Decentralized and Hybrid Clinical Trials?
DCTs and HCTs offer several benefits to patients, including reduced travel and time commitments, increased access to clinical trials, and greater convenience. They also benefit sponsors and investigators by reducing costs, increasing recruitment, and accelerating trial timelines. Regulators are also recognizing the value of decentralized and hybrid trials, with the FDA issuing guidance on the use of digital health technologies in clinical trials.
Why is a Clinical Platform Required?
To conduct DCTs and HCTs, sponsors and investigators need a clinical platform that can support remote communication, data collection, and monitoring. A clinical platform should provide a secure and compliant environment for data management, facilitate communication between patients and investigators, and allow for real-time monitoring of patient safety and trial progress.
In conclusion, decentralized and hybrid clinical trials are the future of clinical research. They offer several benefits to patients, sponsors, and investigators, and are increasingly being recognized by regulators. To conduct these trials successfully, a clinical platform is required that can support remote communication, data collection, and monitoring.
