2026.7.3 NEWS
Launch of a New Investigator-Initiated Clinical Trial in Collaboration with Community Healthcare Institutions – Publication of a Trial Protocol Paper Incorporating a Decentralized Clinical Trial (DCT) Framework and a Single IRB Model –

【summary】
Submacular hemorrhage can lead to severe visual impairment.

Supported by the Japanese Agency for Medical Research and Development (AMED), we have launched the SACLA trial, an investigator-initiated clinical trial to evaluate the efficacy and safety of tissue plasminogen activator (monteplase) for submacular hemorrhage. Led by nine university hospitals in Kyushu, this trial incorporates a decentralized clinical trial (DCT) framework through role-sharing with community healthcare institutions to reduce patient burden associated with investigational site visits and improve trial accessibility. In addition, by conducting centralized review process through a single Institutional Review Board (IRB), this trial aims to facilitate the efficient and high-quality conduct of an investigator-initiated clinical trial.

This study has been published as a protocol paper in PLOS One, and is expected to contribute to international discussions on innovative approaches to investigator-initiated clinical trials.

Embargoed until July 2, 2026, 2 pm ET
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0353127

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