Home Trial Support in Immunology Clinical Trials

This document is a case study that outlines the implementation of Home Trial Support (HTS) in a phase 3 immunology clinical trial conducted in the UK. The study highlights the challenges faced by participants in traditional immunology trials, such as long durations and frequent assessments, which can hinder patient retention and recruitment. HTS aims to alleviate these burdens by providing clinical activities in participants' homes, thereby enhancing accessibility and supporting long-term engagement. The case study reports that the biotechnology sponsor achieved 100% patient retention during the initial 12-month study period and maintained an 82% retention rate in the open-label extension phase. The study involved 75 patients and 1,349 HTS visits across three UK sites, demonstrating the effectiveness of the HTS model in improving recruitment timelines and patient experience while ensuring protocol compliance. The results indicate that HTS can significantly enhance patient-centered care in complex immunology studies.