P213: Pioneering Use of a Decentralized Clinical Trial Model Leading to Faster Patient Recruitment in a Rare Cancer Study in Japan
Poster Presenter
Hiroya Taniguchi
Department of Clinical Oncology
Aichi Cancer Center Hospital Japan
Objectives
Here, we present Japan's first fully remote clinical trial of an oral anticancer drug, a significant advancement allowing patients to participate in investigational new drug (IND) trials without traveling to distant sites.
Method
WJOG15221M/ALLBREAK is a phase II open-label, single-arm, basket study with a decentralized remote design, for which patients with advanced or recurrent ALK fusion-positive solid tumors (except NSCLC) are currently being enrolled. The target enrollment was 14 as an initial plan.
Results
Nationwide comprehensive genomic profiling identified ALK fusion cases, with patients referred to one of 10 investigational sites. ACCH facilitated remote enrollment for those unable to attend. Partner hospitals, meeting specific clinical trial experience and audit criteria, signed contracts for conducting protocol-specified tests, while ACCH retained medical care responsibility. Initial medical evaluations and informed consents were remotely coordinated by ACCH via video conferencing, with documentation sent to ACCH. Eligible patients received home-delivered brigatinib, with regular blood tests and CT scans performed locally and results sent to ACCH for treatment continuation and efficacy/safety assessment. As of January 31, 12 patients have been enrolled, including 5 (42%) with remote participation. Each patient undergo nvestigator's examination via video conference system at their nearby hospital.
Conclusion
This remote approach proved crucial for their enrollment, highlighting its potential to boost participation in clinical trials. No significant deviations have occurred, thanks to effective collaboration with partner physicians. This format allows patients to access new treatments while maintaining their existing doctor relationships, ensuring safe and comfortable participation in trials. Consequently, we maximized three-way telemedicine (D to P with D) for routine online visits, beyond the initial examination.
In Japan, comprehensive genomic profiling tests have been covered by the National Health Insurance since 2019, aiding personalized cancer therapy. However, only about 4%-13% of patients receive genomically matched therapy, partly due to limited access to early phase-matched clinical trials, usually in few urban centers. The reluctance of pharmaceutical companies to develop treatments for rare cancer subtypes identified by CGP, due to low profitability, is another barrier. Our DCT framework addresses these issues by enabling easier patient enrollment and reducing costs through fewer trial sites and personnel.
