Realizing Equitable Precision Oncology via Remote Participation - Japan's First Fully Decentralized Trial

Sep 29, 2026

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Decentralized clinical trials (DCTs) aim to expand access to precision oncology for patients with rare genomic alterations constrained by geography or logistics. The letter describes successful implementation of WJOG15221M/ALLBREAK, Japan’s first fully remote investigator-initiated oncology trial, targeting ALK fusion-positive solid tumors excluding non-small cell lung cancer. Using oral brigatinib and embedding trial options in the national CGP program, remote participation enabled faster accrual and equitable trial access across dispersed patients.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

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Letter to the Editor

Background and need for DCTs

Trial overview: WJOG15221M/ALLBREAK

National CGP pathway integration

Remote implementation methods

Accrual results and impact

Cancer Science LETTER TO THE EDITOR OPEN ACCESS Realizing Equitable Precision Oncology via Remote Participation: Japan's First Fully Decentralized Trial (WJOG15221M) Hiroya Taniguchi1 | Toshiki Masuishi1 | Tomoki Sakakida1,2 | Takatsugu Ogata1,3 | Nobumasa Mizuno4,5 | Masashi Ando1,4 | Kei Muro1 | Hidetoshi Hayashi6 1Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan | 2Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan | 3Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan | 4Department of Clinical Research Support Section, Aichi Cancer Center Hospital, Nagoya, Japan | 5Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan | 6Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan Correspondence: Hiroya Taniguchi ([hiroya.taniguchi@aichi-cc.jp](hiroya.taniguchi@aichi-cc.jp)) Received: 8 August 2025 | Revised: 8 October 2025 | Accepted: 16 October 2025 Funding: This work was supported by Takeda Pharmaceutical Company Limited, which also supplied the investigational drug, brigatinib. This study was also partially supported by a research grant from the Japan Agency for Medical Research and Development (AMED) under Grant Number 23yk0126021h0001 and 24yk0126028h0001, as part of its initiative to promote innovative cancer clinical trials. Dear Editor, Decentralized clinical trials (DCTs) offer a potential solution to broaden access to precision oncology, particularly for patients with rare genomic alterations facing geographic or logistical barriers [1]. However, implementing DCTs in oncology remains challenging, illustrated by the early termination of the TELEPIK trial (assessing remote toxicity monitoring for PIK3CA-mutant breast cancer), which enrolled only two patients in 6 months due to recruitment and operational difficulties [2] . Against this backdrop, we report the successful implementation of the WJOG15221M/ALLBREAK (jRCT2041210148) trial, Japan's first fully remote, investigator-initiated oncology trial. This study targeted patients with ALK fusion-positive solid tumors (excluding non-small cell lung cancer)—a rare subgroup with limited options—using oral brigatinib, a well-tolerated ALK inhibitor suitable for decentralized administration. Japan's national comprehensive genomic profiling (CGP) program, reimbursed since 2019, identifies patients with actionable mutations after standard therapy [3]. As of May 2025, ~280 designated hospitals performed ~20,000 tests annually, with results reviewed by molecular tumor boards and shared with referring institutions. For ALK fusions, reports explicitly listed WJOG15221M as an option, offering on-site or remote participation. Embedding trial information in CGP reports effectively expanded access for geographically dispersed patients. Details of the remote implementation methods have been previously described in our prior publication [4] . Briefly, remote enrollment was conducted via agreements with local institutions, enabling standard assessments and hybrid consent, with oversight maintained through telemedicine and centralized review. These institutions, referred to as partner hospitals, were not predetermined but were contracted on a case-by-case basis when candidate patients were identified. To qualify as a partner, institutions needed to be able to conduct protocol-specified CT and blood examinations and to conclude agreements compliant with Article 39-2 of Japan's GCP. Notably, the contracts were executed within 1 month using pre-established frameworks, and investigational drugs were shipped directly to patients. WJOG15221M was initially designed in 2022 as a traditional, site-based trial across 10 institutions, targeting 14 patients over 30 months. Patient enrollment began in May 2022. The initial target of 14 patients was achieved in March 2025. A subsequent protocol amendment,

FAQs

What problem do decentralized clinical trials address in precision oncology?

They broaden access for patients with rare genomic alterations who face geographic or logistical barriers, enabling participation beyond traditional site-based recruitment.

Which patient population and therapy were studied in WJOG15221M/ALLBREAK?

The trial targeted ALK fusion-positive solid tumors excluding non-small cell lung cancer, using oral brigatinib for decentralized administration.

How was remote participation operationalized in the trial?

Partner hospitals were contracted case-by-case to perform protocol-specified assessments and execute GCP-compliant agreements, with oversight via telemedicine and centralized review; investigational drugs were shipped directly to patients.

Sep 29, 2026

Uploaded by Aria