Implementation of a Fully Decentralized Clinical Trial Design in a Psycho-Oncology Trial

Introduction/Objectives We propose and conduct an infrastructure for a fully remote, decentralized Psycho-Oncology trial using smartphones. The data collection flow and mechanism are discussed. Methods The Decentralized Clinical Trial system was built by a multidisciplinary team of researchers, data center members, and vendors. We facilitated virtual trials through web-based systems and zero site visit, Web-recruiting, eConsent, ePRO, Apps, and Google Analytics. Results Virtual Clinical Trials enabled via technological levers spread and improved the efficiency of clinical trials. Considering the characteristics of the research, building part or all of the web-based system dramatically reduced the burden on patients and researchers. Conclusions We would like to emphasize the potential benefits of our novel strategy of conducting a fully decentralized clinical trial while it is always important to take every possible precaution to ensure that participants who are not proficient with digital technology are not disadvantaged.