Measuring the added benefits of decentralized trial elements (SHASTA): impact on enrollment, demographics, and data completeness through a single sponsor

Abstract This paper explores the impact of decentralized clinical trial (DCT) elements through a single Sponsor’s perspective, measuring outcomes such as enrollment rate, baseline demographics, and data quality. Analyzing data from six studies – including four interventional and two observational – provides insights into the efficacy and challenges of implementing DCTs. While decentralized approaches offer enhanced data completeness due to direct access to medical records and ancillary care, they also present significant data collection burden. For example, obtaining and abstracting relevant information from medical records is a substantial effort. The study highlights that while DCTs are promising, they are not a universal solution. Having more tangible metrics around benefits and limitations will help researchers design more fit-for-purpose approaches. Moreover, the skills and infrastructure developed for DCTs can pave the way for future decentralized healthcare. As patients become increasingly digitally savvy, the integration of technology into clinical trials is expected to enhance convenience and improve informed health decisions.