CONCEPT

Japan Clinical Trial Transformation (CTX) Research Society aims to enhance participation in global clinical trials and resolve drug lag / drug loss issues by transforming the clinical trial environment in Japan through multi stakeholder engagement.

• PURPOSEEnhancing participation in global clinical trials by transforming the clinical trial environment in Japan through multi-stakeholder engagement.
• VISIONContributing to the advancement of pharmaceutical development in Japan through policy recommendations and initiatives that support the dissemination of CTX.
• MISSIONAdvancing the efficiency of clinical trials through CTX, while enhancing participation in global clinical trials, to deliver new therapeutic options to patients more quickly on a world level.

BACKGROUND

In recent years, the issue of drug lag/ drug loss*2 in Japan has once again become a concern, prompting a sense of urgency in government committees. One of the contributing factors is the low participation rate of Japan in global clinical trials (Japan's participation rate was 21.0% for 1,035 international collaborative trials conducted in 2018*3). To ensure access to new drugs, it is crucial for Japan to establish an environment for global clinical trials, in other words, to be "chosen for clinical trials." CTX is a key means to achieve this.

• ※2 Drug lag/ drug loss refer to the time lag or inability to use a drug in Japan that has already been approved and utilized in other countries.
• ※3 Office of Pharmaceutical Industry Research (July 2022), 「近年における国際共同治験の動向調査」政策研ニュースNo.66

PROSPECTS

First, we will focus on the recent topic of DCT and generate concrete achievements.
Then, we plan to gradually expand the scope of discussion in line with the objectives of our association to promote CTX in relevant areas. We will examine the significance of clinical trial participation in addressing drug lag/loss, ensuring equal opportunities for patients, and other aspects from the perspectives of DCT, QbD, FMV, and other methods.

• Issues in Japan's
  Clinical Trial Environment
• Transformaion to make clinical trials
  more efficient and effective
• Improving Japan's Participation
  in Global Clinical Trials
• Providing new drugs to Japanese Patients
  as Early as Possible

Discussion on Advancing CTX in Japan from the Perspectives of Industry, Government, Academia, and Patients

MEMBERS

Japan CTX　Research Society is composed of members from various stakeholders involved in clinical trials, including pharmaceutical companies, CROs, SMOs, IT vendors, academia, and others. Additionally, government officials and other relevant parties participate as observers (as of March 1, 2024)

• Aichi Cancer Center
• EPS Corporation
• A2 Healthcare Corporation
• Otsuka Pharmaceutical Co., Ltd.
• Okayama University Hospital
• Kindai University Hospital
• SUSMED, Inc.
• CMIC Co., Ltd.
• TechDoctor, Inc.
• Tokyo Center Clinic
• Nippon Medical School
• Eli Lilly Japan K.K.
• Pfizer R&D Japan G.K.
• Falma
• Mediford Corporation
• Merck Biopharma Co., Ltd.
• Janssen Pharmaceutical K.K.
• Linical Co., Ltd.
• Buzzreach Inc.
• IQVIA Site Solutions Japan G.K.
• Medical Research Network Japan K.K.
• MEDICOLAB Corp.
• MICIN, Inc.

Japan CTX Research Society is conducting its activities as part of the "Blockbuster TOKYO" program, Tokyo Metropolitan Government’s Startup Support Program specializing in pharmaceutical and medical startups.

Blockbuster TOKYO

Blockbuster TOKYO is a venture incubation support project in the pharmaceutical and medical field supported by the Tokyo Metropolitan Government. Based on an agreement with the Tokyo Metropolitan Government, promoters from various organizations collaborate to form an ecosystem, execute support measures, and establish an environment for creating global-level startups while focusing on brand building and effective communication. Mitsubishi Research Institute, Life Science Innovation Network Japan (Headquarters: Nihonbashi Muromachi, Chuo-ku, Tokyo; President: Hideyuki Okano), and CIC Institute (CIC Japan LLC) (Headquarters: Toranomon, Minato-ku, Tokyo; Executive Officer: Timothy Rowe) have been selected as joint promoters of Blockbuster TOKYO.

https://www.link-j.org/bbt/