Clinical trials tranformation intiative-decentralized clinical trials: a review article

Abstract

In clinical research, Decentralized clinical trials (DCTs) can provide opportunities to maximize efficiencies. Unlike the traditional clinical trial model, Decentralized Clinical Trials (DCTs) promote telemedicine, mobile/local healthcare providers (HCPs), mobile/web-based technology, and direct distribution of Investigational Medicinal Products (IMP) to patients, among other things.  Hence, DCTs are in the spotlight as technology, infrastructure, and knowledge providing a backbone in clinical research. Background: Advances in electronic communication, data storage, emerging technologies, and biosensor development provides new opportunities to exchange information, such as the patient is tested from their home locations and are with locations distant from the investigator. Trials that take place at locations distant from the investigator (i.e., spectrum: CCTs → Hybrid Models → DCTs) in any or all study-related procedures and data is collected electronically fall in the category of the decentralized clinical trial. Trials should be designed to integrate the current healthcare system of the study subject, optimize convenience for study subjects and take advantage of existing programs and data sources including The study subjects themselves through the utilization of telecommunication, videoconferences, mobile or internet-based tools for patient reporting, mobile technology tools and biosensors. Local healthcare providers, home-based healthcare services, pharmacies, clinics, regional hospitals, their perceived obstacles have impeded the widespread use of mobile devices in clinical trials. To encourage solutions to these challenges, The Clinical Trial Transformation Initiative (CTTI) has released best practices and practical methods to advance solutions to these issues that clinical trial sponsors can now use. Conclusion: Decentralized clinical trials are not only operationally feasible and show high recruitment rates, have better compliance, lower dropout rates, and are conducted faster. DCT meets the goal of the industry in being low-risk, high returns trials and can offer a reliable, time-based, and cost-effective approach.