NEW AGENT DEVELOPMENTS IN ‘EARLY-STAGE AND EXPLORATORY CLINICAL TRIAL CENTER’

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Abstract

In 2011, Ministry of Health, Labor, and Welfare designated five ‘early-stage and exploratory clinical trial centers’ and our National Cancer Center was selected as only one center in the oncology field. With the budget, we have organized ‘NCC-Phase I Center’ for the three purposes: to conduct phase I studies including first-in-human (FIH) study, investigator-initiated trials (IIT) with unapproved agents (so-called ‘ishi-syudou chiken’), and translational researches (TRs) during the early clinical studies.

In regard to phase I studies, more than 30 phase I studies have been newly initiated with more than 300 patients recruited in 2011. To date, we have already conducted six industry-sponsored FIH studies and are planning another three FIH studies. Several seeds developed in academic institutions in Japan including our originals are also being planned to start FIH studies either as venture-industry sponsored or as IIT within 1 or 2 years.

As for IIT, we have already organized data centers composed of various specialists for regulation, intellectual properties, biostatistics, pharmacology, monitor, project/data management, advertisement, etc. The first IIT with unapproved agents has been already started and several IITs are being conducted either as domestic or as international studies, which will be initiated within 1 year.

The TR project team composed of basic and clinical researchers has been organized to support preclinical, biomarker, and PK/PD researches, which will support the early developmental studies. Two projects have been already started: to conduct gene-oriented individualized therapy with full exon sequencing and clinical trial for newly developed fusion gene.

The goal of NCC-phase I center is to develop new original agents either from industry or from academia in Japan as well as from the world. More collaborations with industries and other academic institutions including overseas are needed to become the top phase I center in the world.

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