Description
To facilitate the adoption and appropriate use of mobile technology in clinical trials, the Clinical Trials Transformation Initiative (CTTI) initiated the Mobile Clinical Trials (MCT) Program, which includes four projects focused on the following topics: Decentralized Clinical Trials (DCTs), Novel Endpoints, Stakeholder Perceptions, and Mobile Technologies. The MCT DCT Project concentrates on the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States.
For the purposes of these recommendations, DCTs are defined as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product [IMP] is shipped directly to the trial participant).
